Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-25 @ 4:16 PM
Study NCT ID:
NCT02100657
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2014-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C098980', 'term': 'plitidepsin'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@pharmamar.com', 'phone': '00 34 91846 60 00', 'title': 'Pharma Mar S.A.', 'organization': 'Pharma Mar S.A.'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed through study completion, approximately 4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 1, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'asthenia/fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 24, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 62, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'feeling of body temperature change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'scapula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 36, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 17, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 23, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 21, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'aphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 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'MedDRA (16.0)'}, {'term': 'escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recommended Dose of Plitidepsin in Combination With Bortezomib and Dexamethasone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who received at least 1 dose of plitidepsin as a 3-hour i.v. infusion on Days 1 and 15 in combination with BTZ administered s.c. on Days 1, 4, 8 and 11, and DXM orally on Days 1, 8, 15 and 22 q4wk in patients with relapsed and/or refractory MM'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 28-day cycle', 'description': 'To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.', 'unitOfMeasure': 'mg/m^2 of plitidepsin', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose study treatment'}, {'type': 'PRIMARY', 'title': 'Recommended Dose of Bortezomib in Combination With Plitidepsin and Dexamethasone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who received at least 1 dose of plitidepsin as a 3-hour i.v. infusion on Days 1 and 15 in combination with BTZ administered s.c. on Days 1, 4, 8 and 11, and DXM orally on Days 1, 8, 15 and 22 q4wk in patients with relapsed and/or refractory MM'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 28-day cycle', 'description': 'To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.', 'unitOfMeasure': 'mg/m^2 of bortezomib', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose study treatment'}, {'type': 'PRIMARY', 'title': 'Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who received at least 1 dose of plitidepsin as a 3-hour i.v. infusion on Days 1 and 15 in combination with BTZ administered s.c. on Days 1, 4, 8 and 11, and DXM orally on Days 1, 8, 15 and 22 q4wk in patients with relapsed and/or refractory MM'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 28-day cycle', 'description': 'To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.', 'unitOfMeasure': 'mg of dexamethasone', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose study treatment'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 28-day cycle', 'description': 'DLTs were defined as:\n\nHematological Toxicity\n\n* Grade 3/4 neutropenia associated with fever or lasting\\>7 days related to the study treatment\n* Grade 3/4 thrombocytopenia accompanied by grade 3/4 hemorrhage\n* Extensive bone marrow (BM) infiltration, DLT was defined as grade 4 thrombocytopenia with grade 3/4 hemorrhage or grade 4 neutropenia lasting \\>7 days or with fever Non-hematological Toxicity\n* Grade 3/4 nausea and vomiting refractory to antiemetic therapy\n* Grade≥3 muscular Adverse events (AE) (myalgia, muscular weakness, muscle cramps, myopathy)\n* Grade≥3 alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) lasting more than 1 week\n* Grade≥3 bilirubin increase\n* Grade≥3 creatine phosphokinase (CPK) increase\n* Cardiac toxicity\n\n * Symptomatic or treatment-requiring grade ≥1 cardiac arrhythmia related to plitidepsin\n * Grade≥1 left ventricular systolic dysfunction related to plitidepsin\n* Neuropathic pain and peripheral sensory neuropathy related to BTZ', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response According to International Myeloma Working Group Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'categories': [{'title': 'sCR', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'CR', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'VGPR', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'PR', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'MR', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'SD≥4 months', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'SD<4 months', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'PD', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years', 'description': 'Stringent complete response (sCR) normal Free Light Chains (FLC) ratio. No clonal cells Complete response (CR) no serum/urine M-protein, no evidence of soft tissue plasmacytoma. \\<5% clonal plasma cells Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \\>90% reduction in serum M-protein and urine M-protein \\<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \\<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \\>11.5 mg/dL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '22.2', 'groupId': 'OG002', 'lowerLimit': '6.4', 'upperLimit': '47.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years', 'description': 'Overall response rate (ORR), including stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR) according to the International Myeloma Working Group (IMWG) criteria', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '26.6'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '14.4'}, {'value': '12.3', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '23.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first documentation of response to the date of PD or further therapy or death, up to 4 years', 'description': 'Duration of response (DR) was analyzed for all patients in whom a response had been observed and was calculated from the date of the first documentation of response to the date of PD or further therapy or death', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '27.6'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '15.3'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '4.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years', 'description': 'Time to progression (TTP) was calculated from the date of the first infusion to the date of documented PD or death due to PD.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Progression Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'title': 'At 3 months', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '59.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '44.4', 'groupId': 'OG002', 'lowerLimit': '21.5', 'upperLimit': '67.4'}]}]}, {'title': 'At 6 months', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '38.0', 'upperLimit': '100.0'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '100.0'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '47.6'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '74.5'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '100.0'}, {'value': '13.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years', 'description': 'Time to progression (TTP) was calculated from the date of the first infusion to the date of documented PD or death due to PD.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '27.6'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '15.3'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '4.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from the date of the first infusion to the date of documented PD or death, up to 4 years', 'description': 'Progression-free survival (PFS) was calculated from the date of the first infusion to the date of documented PD or death (regardless of the reason), whichever comes first', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'title': 'At 3 months', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '59.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '44.4', 'groupId': 'OG002', 'lowerLimit': '21.5', 'upperLimit': '67.4'}]}]}, {'title': 'At 6 months', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '38.0', 'upperLimit': '100.0'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '100.0'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '47.6'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '74.5'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '100.0'}, {'value': '13.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the date of the first infusion to the date of documented PD or death, up to 4 years', 'description': 'Progression-free survival (PFS) was calculated from the date of the first infusion to the date of documented PD or death (regardless of the reason), whichever comes first', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '27.6'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '15.3'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '4.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first infusion to the date of documented PD or death, up to 4 years', 'description': 'Event-free survival (EFS) was calculated from the date of first infusion to the date of documented PD or death, but could include additional events besides death and PD that were considered of importance', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event-free Survival Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'OG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'classes': [{'title': 'At 3 months', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '59.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '44.4', 'groupId': 'OG002', 'lowerLimit': '21.5', 'upperLimit': '67.4'}]}]}, {'title': 'At 6 months', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '38.0', 'upperLimit': '100.0'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '100.0'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '47.6'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '74.5'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '100.0'}, {'value': '13.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from the date of first infusion to the date of documented PD or death, up to 4 years', 'description': 'Event-free survival (EFS) was calculated from the date of first infusion to the date of documented PD or death, but could include additional events besides death and PD that were considered of importance', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'FG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'FG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}], 'periods': [{'title': 'Cohort 1: Dose Level 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treatment-related adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Cohort 2: Dose Level 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treatment-related adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Cohort 3: Dose Level 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-treatment related adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Never were treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Treatment-related adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '39 patients were enrolled at 7 sites in Spain and France and 36 of them were treated with the combination of plitidepsin, bortezomib (BTZ) and dexamethasone (DXM). Patients who participated between 18Jun2014-30Aug2018 (cutoff date). The first dose of the first cycle was administered on 7Jul2014 and the last cycle was administered on 25May2018', 'preAssignmentDetails': 'Age≥18;Consent Informed (CI) signed;Confirmed diagnosis of MM according to the Durie-Salmon criteria;Relapsed and/or refractory disease;Eastern Cooperative Oncology Group performance status (ECOG PS)≤2'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'BG001', 'title': 'Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'BG002', 'title': 'Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)', 'description': 'Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '57', 'upperLimit': '80'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '58', 'upperLimit': '76'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '80'}, {'value': '66', 'groupId': 'BG003', 'lowerLimit': '51', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG PS', 'classes': [{'categories': [{'title': 'PS 0', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'PS 1', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'PS 2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead', 'unitOfMeasure': 'Participants'}, {'title': 'Multiple myeloma type at diagnosis', 'classes': [{'categories': [{'title': 'Non-secretory', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Oligosecretory', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Secretory', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Durie-Salmon stage at diagnosis', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Stage II', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Stage III', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Stage I: small number of myeloma cells. All are present:\n\n* Hemoglobin \\>100 g/L\n* Blood calcium \\<2.8 mmol/L\n* No areas of bone damage or a solitary plasmacytoma of the bone\n* Immunoglobulin G (IgG) \\<50 g/L\n* Immunoglobulin A (IgA) \\<30 g/L\n* Urine M-protein \\<4 g\n\nStage II: Moderate number of myeloma cells. The features are between stage 1 and 3\n\nStage III: Large number of myeloma cells. One/more are present:\n\n* Hemoglobin \\<85 g/L\n* Blood calcium \\>2.8 mmol/L\n* Several areas of bone damage\n* IgG \\>70 g/L\n* IgA \\>50 g/L\n* Urine M-protein \\>12 g', 'unitOfMeasure': 'Participants'}, {'title': 'Durie-Salmon stage at diagnosis', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Stage II', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Stage III', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Stage I: small number of myeloma cells. All are present:\n\n* Hemoglobin more than 100 g/L\n* Blood calcium less than 2.8 mmol/L\n* No areas of bone damage or a solitary plasmacytoma of the bone\n* IgG less than 50 g/L\n* IgA less than 30 g/L\n* Urine M-protein less than 4 g\n\nStage II: Moderate number of myeloma cells. The features are between stage 1 and 3\n\nStage III: Large number of myeloma cells. One/more are present:\n\n* Hemoglobin less than 85 g/L\n* Blood calcium more than 2.8 mmol/L\n* Several areas of bone damage\n* IgG more than 70 g/L\n* IgA more than 50 g/L\n* Urine M-protein more than 12 g', 'unitOfMeasure': 'Participants'}, {'title': 'Durie-Salmon subclassification at diagnosis', 'classes': [{'categories': [{'title': 'Substage A', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Substage B', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The stages of multiple myeloma are further divided according to creatinine level in the blood, which shows how well the kidneys are working.\n\nSubstage A: Kidney function is normal. Creatinine level is less than 180 µmol/L.\n\nSubstage B: Kidney function is abnormal. Creatinine level is 180 µmol/L or more.', 'unitOfMeasure': 'Participants'}, {'title': 'International Staging System at diagnosis', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Stage II', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Stage III', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The International Staging System uses the results of 2 blood tests: albumin and beta-2-microglobulin level.\n\nStage 1: Beta-2-microglobulin level less than 3.5 mg/L and albumin level more equal than 35 g/L.\n\nStage 2: Beta-2-microglobulin level less than 3.5 mg/L and Albumin level less than 35 g/L or beta-2-microglobulin level is more than 3.5 mg/L but less than 5.5 mg/L and any albumin level.\n\nStage 3: Beta-2-microglobulin is 5.5 mg/L or more and any albumin level.', 'unitOfMeasure': 'Participants'}, {'title': 'Disease status with respect to last prior therapy', 'classes': [{'categories': [{'title': 'Relapsed', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Total refractory', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Best response to last prior anticancer therapy', 'classes': [{'categories': [{'title': 'CR', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'VGPR', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'PR', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'SD', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'PD', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'UK', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'CR, complete response; PD, progressive disease; PR, partial response; RD, recommended dose; SD, stable disease; UK, unknown; VGPR, very good partial response.', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '70.9', 'groupId': 'BG000', 'lowerLimit': '55.5', 'upperLimit': '81.7'}, {'value': '65.1', 'groupId': 'BG001', 'lowerLimit': '53.0', 'upperLimit': '80.9'}, {'value': '72.0', 'groupId': 'BG002', 'lowerLimit': '46.2', 'upperLimit': '90.0'}, {'value': '70.8', 'groupId': 'BG003', 'lowerLimit': '46.2', 'upperLimit': '90.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body surface area', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'BG000', 'lowerLimit': '1.5', 'upperLimit': '1.9'}, {'value': '1.7', 'groupId': 'BG001', 'lowerLimit': '1.6', 'upperLimit': '2.0'}, {'value': '1.8', 'groupId': 'BG002', 'lowerLimit': '1.4', 'upperLimit': '2.1'}, {'value': '1.8', 'groupId': 'BG003', 'lowerLimit': '1.4', 'upperLimit': '2.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from diagnosis to first infusion', 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '150'}, {'value': '55.8', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '133'}, {'value': '64.5', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '196'}, {'value': '64.5', 'groupId': 'BG003', 'lowerLimit': '26', 'upperLimit': '196'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from last progressive disease to first infusion', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '16.5'}, {'value': '5.3', 'groupId': 'BG001', 'lowerLimit': '0.7', 'upperLimit': '5.9'}, {'value': '1.6', 'groupId': 'BG002', 'lowerLimit': '0.4', 'upperLimit': '53.9'}, {'value': '1.6', 'groupId': 'BG003', 'lowerLimit': '0.4', 'upperLimit': '53.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Lines of prior chemotherapy', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '4', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'lines of chemotherapy', 'dispersionType': 'FULL_RANGE'}, {'title': 'Agents of prior chemotherapy', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '11'}, {'value': '5.0', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '8.0', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '7.0', 'groupId': 'BG003', 'lowerLimit': '2', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Agents of chemotherapy', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-08', 'size': 942833, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-22T05:53', 'hasProtocol': True}, {'date': '2016-04-22', 'size': 1276290, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-22T05:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-17', 'studyFirstSubmitDate': '2014-03-21', 'resultsFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2014-03-27', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-17', 'studyFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recommended Dose of Plitidepsin in Combination With Bortezomib and Dexamethasone', 'timeFrame': 'After 28-day cycle', 'description': 'To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.'}, {'measure': 'Recommended Dose of Bortezomib in Combination With Plitidepsin and Dexamethasone', 'timeFrame': 'After 28-day cycle', 'description': 'To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.'}, {'measure': 'Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib', 'timeFrame': 'After 28-day cycle', 'description': 'To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.'}, {'measure': 'Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'After 28-day cycle', 'description': 'DLTs were defined as:\n\nHematological Toxicity\n\n* Grade 3/4 neutropenia associated with fever or lasting\\>7 days related to the study treatment\n* Grade 3/4 thrombocytopenia accompanied by grade 3/4 hemorrhage\n* Extensive bone marrow (BM) infiltration, DLT was defined as grade 4 thrombocytopenia with grade 3/4 hemorrhage or grade 4 neutropenia lasting \\>7 days or with fever Non-hematological Toxicity\n* Grade 3/4 nausea and vomiting refractory to antiemetic therapy\n* Grade≥3 muscular Adverse events (AE) (myalgia, muscular weakness, muscle cramps, myopathy)\n* Grade≥3 alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) lasting more than 1 week\n* Grade≥3 bilirubin increase\n* Grade≥3 creatine phosphokinase (CPK) increase\n* Cardiac toxicity\n\n * Symptomatic or treatment-requiring grade ≥1 cardiac arrhythmia related to plitidepsin\n * Grade≥1 left ventricular systolic dysfunction related to plitidepsin\n* Neuropathic pain and peripheral sensory neuropathy related to BTZ'}], 'secondaryOutcomes': [{'measure': 'Response According to International Myeloma Working Group Criteria', 'timeFrame': 'Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years', 'description': 'Stringent complete response (sCR) normal Free Light Chains (FLC) ratio. No clonal cells Complete response (CR) no serum/urine M-protein, no evidence of soft tissue plasmacytoma. \\<5% clonal plasma cells Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \\>90% reduction in serum M-protein and urine M-protein \\<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \\<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \\>11.5 mg/dL'}, {'measure': 'Overall Response Rate', 'timeFrame': 'Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years', 'description': 'Overall response rate (ORR), including stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR) according to the International Myeloma Working Group (IMWG) criteria'}, {'measure': 'Duration of Response', 'timeFrame': 'From the date of the first documentation of response to the date of PD or further therapy or death, up to 4 years', 'description': 'Duration of response (DR) was analyzed for all patients in whom a response had been observed and was calculated from the date of the first documentation of response to the date of PD or further therapy or death'}, {'measure': 'Time to Progression', 'timeFrame': 'From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years', 'description': 'Time to progression (TTP) was calculated from the date of the first infusion to the date of documented PD or death due to PD.'}, {'measure': 'Time to Progression Rates', 'timeFrame': 'From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years', 'description': 'Time to progression (TTP) was calculated from the date of the first infusion to the date of documented PD or death due to PD.'}, {'measure': 'Progression-free Survival', 'timeFrame': 'from the date of the first infusion to the date of documented PD or death, up to 4 years', 'description': 'Progression-free survival (PFS) was calculated from the date of the first infusion to the date of documented PD or death (regardless of the reason), whichever comes first'}, {'measure': 'Progression-free Survival Rates', 'timeFrame': 'From the date of the first infusion to the date of documented PD or death, up to 4 years', 'description': 'Progression-free survival (PFS) was calculated from the date of the first infusion to the date of documented PD or death (regardless of the reason), whichever comes first'}, {'measure': 'Event-free Survival', 'timeFrame': 'From the date of first infusion to the date of documented PD or death, up to 4 years', 'description': 'Event-free survival (EFS) was calculated from the date of first infusion to the date of documented PD or death, but could include additional events besides death and PD that were considered of importance'}, {'measure': 'Event-free Survival Rates', 'timeFrame': 'from the date of first infusion to the date of documented PD or death, up to 4 years', 'description': 'Event-free survival (EFS) was calculated from the date of first infusion to the date of documented PD or death, but could include additional events besides death and PD that were considered of importance'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple myeloma', 'plitidepsin', 'APLIDIN'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma.', 'detailedDescription': 'Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM), to determine the efficacy of the combination plitidepsin/bortezomib/dexamethasone, to evaluate the safety and tolerability of the combination in patients with relapsing and/or refractory MM and to study the pharmacokinetics (PK) and pharmacodynamics (PDy) of plitidepsin in combination with bortezomib and dexamethasone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Prior autologous transplantation (HSCT) patients are allowed.\n* Patients must have received at least one previous treatment line of induction, chemotherapy, chemotherapy and transplantation or previous treatment with bortezomib or another proteasome drug\n\nExclusion Criteria:\n\n* Previous treatment with plitidepsin.\n* Active or metastatic primary malignancy other than MM.\n* Serious concomitant systemic disorders\n* History of hypersensitivity reactions to bortezomib, polyoxyl 35 castor oil or mannitol\n* Neuropathy\n* Pregnant and/or lactating women\n* HIV infection\n* Active hepatitis B or C virus infection.\n* Treatment with any Investigational Medicinal Product (IMP) in the 30 days before inclusion in the study\n* Plasma cell leukemia at the time of study entry\n* Contraindication for the use of steroids'}, 'identificationModule': {'nctId': 'NCT02100657', 'briefTitle': 'Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmaMar'}, 'officialTitle': 'Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'APL-A-012-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'plitidepsin + bortezomib + dexamethasone', 'description': 'Plitidepsin will be administered as a 3-hour (h) intravenous (i.v.) infusion on Day (D) 1 and 15, every four weeks (q4wk).\n\nBortezomib will be administered as a subcutaneous (s.c.) injection on D1, 4, 8 and 11, q4wk, for a maximum of eight cycles.\n\nDexamethasone will be taken orally on D1, 8, 15 and 22, q4wk', 'interventionNames': ['Drug: Plitidepsin', 'Drug: Bortezomib', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Plitidepsin', 'type': 'DRUG', 'armGroupLabels': ['plitidepsin + bortezomib + dexamethasone']}, {'name': 'Bortezomib', 'type': 'DRUG', 'armGroupLabels': ['plitidepsin + bortezomib + dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['plitidepsin + bortezomib + dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Germans Trias I Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clínica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'MD Anderson Cancer Center Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politècnic la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmaMar', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}