Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
Study NCT ID:
NCT00793650
Status:
TERMINATED
Last Update Posted:
2012-08-30
First Post:
2008-11-17
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D008558', 'term': 'Melphalan'}], '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': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sloni01@emory.edu', 'phone': '404-727-5572', 'title': 'Dr. Sagar Lonial', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bortezomib Before HD Melphalan', 'description': 'All patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Bortezomib After HD melphalanAll', 'description': 'patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2', 'otherNumAtRisk': 20, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Muscositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Liver Toxicities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Clostridium diificile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Renal toxicities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Cognitive disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'DVT/PE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pulmonary toxicities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Incontinenece', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Gastrointestinal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Neutopenic colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Blisters on Feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Urinary retension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'A.fib', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}], 'seriousEvents': [{'term': 'Expired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Acute pulmonary embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hemorrhage/Bleeding-Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib Before HD Melphalan', 'description': 'All patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2'}, {'id': 'OG001', 'title': 'Bortezomib After HD melphalanAll', 'description': 'patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2'}], 'classes': [{'title': 'Median time for platelet recovery', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '23'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '58'}]}]}, {'title': 'Median time for neutrophil recovery', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '18'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 30 after transplant', 'description': 'Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10\\^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'As per the protocol'}, {'type': 'SECONDARY', 'title': 'Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib Before Melphalan', 'description': 'All patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2'}, {'id': 'OG001', 'title': 'Bortezomib After Melphalan', 'description': 'patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2'}], 'classes': [{'title': 'Complete response (CR)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'VGPR-Very good partial remission', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days after transplant', 'description': 'CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and \\<=5% plasma cells in bone marrow.\n\nVGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\<100mg per 24 hour.\n\nPartial Response:\\>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \\>=90% or to \\<200mg per 24 hour.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As per the protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bortezomib Before HD Melphalan', 'description': 'All patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2'}, {'id': 'FG001', 'title': 'Bortezomib After HD melphalanAll', 'description': 'patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bortezomib Before HD Melphalan', 'description': 'All patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2'}, {'id': 'BG001', 'title': 'Bortezomib After HD melphalanAll', 'description': 'patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\\^2'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.32', 'spread': '7.92', 'groupId': 'BG000'}, {'value': '58.75', 'spread': '8.05', 'groupId': 'BG001'}, {'value': '58.54', 'spread': '7.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-17', 'studyFirstSubmitDate': '2008-11-17', 'resultsFirstSubmitDate': '2012-03-14', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-16', 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Engraftment', 'timeFrame': 'Day 30 after transplant', 'description': 'Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10\\^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.'}], 'secondaryOutcomes': [{'measure': 'Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.', 'timeFrame': '100 days after transplant', 'description': 'CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and \\<=5% plasma cells in bone marrow.\n\nVGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\<100mg per 24 hour.\n\nPartial Response:\\>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \\>=90% or to \\<200mg per 24 hour.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer', 'Multiple Myeloma', 'Peripheral Blood Stem Cell Transplant'], 'conditions': ['Cancer', 'Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with multiple myeloma who are eligible for an autologous peripheral blood progenitor transplant\n* Male and female subjects between the age of 18 and 70 years.\n* Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care\n* Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements\n* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.\n* Male subjects agrees to use an acceptable method for contraception for the duration of the study.\n* Biopsy proven diagnosis of multiple myeloma from bone marrow aspirate and biopsy prior to study initiation\n* Patient has achieved less than 90% disease reduction from previous treatment prior to transplant (as measured by serum or urine protein electrophoresis) and has more than 5% plasma cells in the bone marrow, or patient has progressed and has more than 5% plasma cells in the bone marrow.\n* Karnofsky Performance Status score of ≥ 60%\n* Patient has met the following laboratory requirements prior to Day -4\n* Platelet count ≥ 50, 000/mm3\n* Absolute Neutrophil Count ≥ 500/mm3\n* Hemoglobin ≥ 10 g/dL (transfusion allowed to meet this criterion)\n* Calculated creatinine clearance ≥ 30mL/min\n* Toxic effects of previous therapy or surgery resolved to Grade 2 or better\n\nExclusion Criteria:\n\n* Unsupportable anemia with \\< 10b/dL\n* Patient has a calculated or measured creatinine clearance of \\< 30mL/min within 14 days before enrollment\n* Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment\n* Patient has hypersensitivity to bortezomib, boron or mannitol\n* Patient has had an allergic reaction to melphalan or chlorambucil\n* Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.\n* Patient has received other investigational drugs with 14 days before enrollment\n* Serious medical or psychiatric illness likely to interfere with participation in this clinical study\n* Cardiac or pulmonary dysfunction such that patients do not meet institutional pre-transplant evaluation criteria\n* Known central nervous system involvement or suspicion of involvement with Myeloma\n* Other active malignancies (with the exception of basal and squamous cell skin cancer) within 5 years of study entry. Patients with treated prostate or cervical cancer in situ who are 2 or more years from therapy and remain free of disease may be entered into the study at the investigator's discretion.\n* Known to be HIV positive, HIV-1 positive"}, 'identificationModule': {'nctId': 'NCT00793650', 'briefTitle': 'Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study', 'orgStudyIdInfo': {'id': '080-2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bortezomib before Melphalan', 'description': 'Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan.', 'interventionNames': ['Drug: Bortezomib', 'Drug: Melphalan', 'Procedure: Autologous PBSC Transplant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bortezomib after Melphalan', 'description': 'Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.', 'interventionNames': ['Drug: Bortezomib', 'Drug: Melphalan', 'Procedure: Autologous PBSC Transplant']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Bortezomib or Velcade'], 'description': 'Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B.', 'armGroupLabels': ['Bortezomib after Melphalan', 'Bortezomib before Melphalan']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Bortezomib or Velcade'], 'description': 'All patients received melphalan (100 mg/m\\^2/day × 2; days\n\n-3 and -2), for a total dose of 200 mg/m\\^2.', 'armGroupLabels': ['Bortezomib after Melphalan', 'Bortezomib before Melphalan']}, {'name': 'Autologous PBSC Transplant', 'type': 'PROCEDURE', 'description': 'Day 0 consists of the stem cell infusion.', 'armGroupLabels': ['Bortezomib after Melphalan', 'Bortezomib before Melphalan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Sagar Lonial, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Winship Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sagar Lonial', 'investigatorAffiliation': 'Emory University'}}}}