Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-29 @ 1:43 AM
Study NCT ID:
NCT02921802
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2016-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Special Use Results Surveillance of Revlimid 5mg Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D064793', 'term': 'Teratogenesis'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D015275', 'term': 'Tumor Lysis Syndrome'}], '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'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4626}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2013-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2016-09-30', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'Up to 6 months', 'description': 'Number of participants with adverse events for 6 month treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Teratogenicity', 'Thrombocytopenia and haemorrhage', 'Neutropenia and infection', 'Venous thromboembolism', 'Allergic reactions', 'Diarrhoea or constipation', 'Peripheral neuropathy', 'Cardiac failure', 'Arrhythmia', 'Renal failure', 'Myocardial infarction', 'Interstitial lung disease', 'Tumour lysis syndrome', 'Transformation from myelodysplastic syndrome to acute myeloid leukemia'], 'conditions': ['Multiple Myeloma', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.\n\n1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached.\n2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Pomalyst will be targeted in this surveillance.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT02921802', 'briefTitle': 'A Study of Special Use Results Surveillance of Revlimid 5mg Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'Revlimid 5 mg Capsules Special Use-results Surveillance (All-case Surveillance)', 'orgStudyIdInfo': {'id': 'NIS-Celgene-JP-PMS-001a'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who received Revlimid', 'description': 'Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '651-0072', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Shinko Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}