Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT00520767
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2007-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075363', 'term': 'Immunoglobulin Light-chain Amyloidosis'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D005434', 'term': 'Flow Cytometry'}], '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'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'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'}, {'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zonderj@karmanos.org', 'phone': '313-576-8732', 'title': 'Jeffrey Zonder, M.D.', 'organization': 'Barbara Ann Karmanos Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Mix of previously treated \\& newly diagnosed pts (populations which may have different prognoses), plus the relatively small trial size limit conclusions one can draw re: relative efficacy of MDV (vs CyBorD or Mel-Dex, for example)'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4\n\nbortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22\n\ndexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23\n\nmelphalan: Melphalan 9 mg/m2/day days 1-4\n\nmicroarray analysis: ≤28 days prior to enrollment\n\nflow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.\n\nlaboratory biomarker analysis: ≤28 days prior to enrollment\n\nquality-of-life assessment: Start of each cycle', 'otherNumAtRisk': 35, 'otherNumAffected': 3, 'seriousNumAtRisk': 35, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with Normal ANC-Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain-chest wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mental Status Change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain-Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with Normal ANC-Catheter related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with Normal ANC-Skin (cellulitis)-shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Hematologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4\n\nbortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22\n\ndexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23\n\nmelphalan: Melphalan 9 mg/m2/day days 1-4\n\nmicroarray analysis: ≤28 days prior to enrollment\n\nflow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.\n\nlaboratory biomarker analysis: ≤28 days prior to enrollment\n\nquality-of-life assessment: Start of each cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals evaluable for response'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4\n\nbortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22\n\ndexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23\n\nmelphalan: Melphalan 9 mg/m2/day days 1-4\n\nmicroarray analysis: ≤28 days prior to enrollment\n\nflow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.\n\nlaboratory biomarker analysis: ≤28 days prior to enrollment\n\nquality-of-life assessment: Start of each cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '45.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'time from day of registration until 72 months.', 'description': 'time from day of registration until day of death.', 'unitOfMeasure': 'month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4\n\nbortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22\n\ndexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23\n\nmelphalan: Melphalan 9 mg/m2/day days 1-4\n\nmicroarray analysis: ≤28 days prior to enrollment\n\nflow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.\n\nlaboratory biomarker analysis: ≤28 days prior to enrollment\n\nquality-of-life assessment: Start of each cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '34.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'start of treatment until 72 months', 'description': 'Time from start of treatment until date of documented disease progression, removal from protocol due to toxicity, or death from any cause.', 'unitOfMeasure': 'month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Organ Response Rate (OrR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4\n\nbortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22\n\ndexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23\n\nmelphalan: Melphalan 9 mg/m2/day days 1-4\n\nmicroarray analysis: ≤28 days prior to enrollment\n\nflow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.\n\nlaboratory biomarker analysis: ≤28 days prior to enrollment\n\nquality-of-life assessment: Start of each cycle'}], 'timeFrame': 'Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.', 'reportingStatus': 'POSTED', 'populationDescription': 'Not collected not analyzed.'}, {'type': 'SECONDARY', 'title': 'Overall Hematologic Response Rate (OHR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4\n\nbortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22\n\ndexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23\n\nmelphalan: Melphalan 9 mg/m2/day days 1-4\n\nmicroarray analysis: ≤28 days prior to enrollment\n\nflow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.\n\nlaboratory biomarker analysis: ≤28 days prior to enrollment\n\nquality-of-life assessment: Start of each cycle'}], 'timeFrame': 'Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.', 'reportingStatus': 'POSTED', 'populationDescription': 'Not collected not analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4\n\nbortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22\n\ndexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23\n\nmelphalan: Melphalan 9 mg/m2/day days 1-4\n\nmicroarray analysis: ≤28 days prior to enrollment\n\nflow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.\n\nlaboratory biomarker analysis: ≤28 days prior to enrollment\n\nquality-of-life assessment: Start of each cycle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4\n\nbortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22\n\ndexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23\n\nmelphalan: Melphalan 9 mg/m2/day days 1-4\n\nmicroarray analysis: ≤28 days prior to enrollment\n\nflow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.\n\nlaboratory biomarker analysis: ≤28 days prior to enrollment\n\nquality-of-life assessment: Start of each cycle'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2007-08-24', 'resultsFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2007-08-24', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-18', 'studyFirstPostDateStruct': {'date': '2007-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Hematologic Response', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'time from day of registration until 72 months.', 'description': 'time from day of registration until day of death.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'start of treatment until 72 months', 'description': 'Time from start of treatment until date of documented disease progression, removal from protocol due to toxicity, or death from any cause.'}, {'measure': 'Organ Response Rate (OrR)', 'timeFrame': 'Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.'}, {'measure': 'Overall Hematologic Response Rate (OHR)', 'timeFrame': 'Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['primary systemic amyloidosis', 'light chain deposition disease'], 'conditions': ['Primary Systemic Amyloidosis', 'Light Chain Deposition Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.gov/clinicaltrials', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Giving bortezomib together with melphalan and dexamethasone may be an effective treatment for primary amyloidosis and light chain deposition disease.\n\nPURPOSE: This phase II trial is studying how well giving bortezomib together with melphalan and dexamethasone works in treating patients with primary amyloidosis or light chain deposition disease.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the complete hematologic response rate at 12 months.\n\nSecondary\n\n* Determine the overall hematologic response rate.\n* Determine the organ response rate.\n* Determine time to treatment failure.\n* Determine the overall survival.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oral melphalan on days 1-4, bortezomib IV on days 1, 8, 15, and 22, and dexamethasone orally or IV on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every 4-6 weeks for up to 20 courses in the absence of disease progression or unacceptable toxicity.\n\nBlood, urine, and bone marrow aspirates are collected at baseline and periodically after treatment to permit the correlation of clinical results with measured molecular events. A single baseline peripheral blood DNA sample is collected for future association studies linking disease onset, progression, and response to administered therapy with single nucleotide polymorphisms. Blood plasma and urine samples are evaluated for proteomic markers associated with disease progression and therapeutic response. Peripheral blood RNA samples are evaluated for transcriptional response to treatment of peripheral blood lymphocytes. Bone marrow aspirates are collected to extract plasma cells by flow cytometry for gene expression profiling.\n\nQuality of life is assessed at the beginning of each course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Biopsy-proven diagnosis of 1 of the following:\n\n * Primary systemic amyloidosis\n\n * Histochemical diagnosis of amyloidosis determined by polarizing microscopy of green bi-refringent material in Congo red-stained tissue specimens or characteristic electron microscopy appearance\n * Light chain deposition disease\n* Measurable disease as defined by one or more of the following:\n\n * Serum monoclonal protein ≥ 0.5 g/dL by serum electrophoresis\n * Urine monoclonal protein \\> 200 mg/tv in a 24 hr urine electrophoresis\n * Serum immunoglobulin free-light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa lambda free light chain ratio\n* Must meet 1 of the following criteria:\n\n * Clonal population of plasma cells in the bone marrow (≤ 30%)\n * Immunohistochemical stain with anti-light chain anti-sera of amyloid fibrils\n* Must not meet the following diagnostic criteria for symptomatic\\* multiple myeloma:\n\n * Lytic lesions on skeletal survey\n * Plasmacytoma\n * Increase in bone marrow plasma cells ≥ 30% NOTE: \\*Patients who meet the International Myeloma Working Group definition of symptomatic multiple myeloma with symptoms attributable only to associated amyloidosis and who do not otherwise meet the criteria for diagnosis of smoldering myeloma are potentially eligible upon approval of the principal investigator.\n* If not previously treated, patient is either not a candidate for autologous stem cell transplantation (ASCT) or has declined the option of ASCT\n\n * Patients who have undergone prior ASCT and have subsequently progressed are eligible, provided other eligibility criteria are met\n* No secondary or familial amyloidosis\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-3\n* Creatinine \\< 5 mg/dL\n* Bilirubin \\< 2.5 times upper limit of normal (ULN)\n* ALT and AST \\< 3 times ULN\n* Absolute neutrophil count ≥ 1,000/mm³\n* Platelet count ≥ 80,000/mm³\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Peripheral sensory neuropathy \\< grade 3\n* No myocardial infarction within the past 6 months\n* No New York Heart Association class III or IV heart failure\n* No uncontrolled angina\n* No severe uncontrolled ventricular arrhythmias\n* No EKG\\* evidence of acute ischemia or active conduction system abnormalities (not including 1st degree AV-block, Wenckebach type 2nd degree heart block, or left bundle branch block) NOTE: \\*Prior to study entry, any EKG screening abnormality must be documented by the investigator as not medically relevant; there is no lower limit of LVEF below which patients are excluded from participation\n* No hypersensitivity to bortezomib, boron, or any of the other agents utilized in this study\n* No serious concurrent illness (e.g., stroke) within the past 30 days\n* No psychiatric illness likely to interfere with study participation\n* No untreated HIV infection\n\n * Patients with asymptomatic HIV infection on active antiretroviral therapy are potentially eligible\n* No diagnosis or treatment of another malignancy within the past 3 years, except completely resected basal cell or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No other investigational drugs within the past 14 days'}, 'identificationModule': {'nctId': 'NCT00520767', 'briefTitle': 'Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease', 'organization': {'class': 'OTHER', 'fullName': 'Barbara Ann Karmanos Cancer Institute'}, 'officialTitle': 'A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease', 'orgStudyIdInfo': {'id': '2006-132'}, 'secondaryIdInfos': [{'id': 'P30CA022453', 'link': 'https://reporter.nih.gov/quickSearch/P30CA022453', 'type': 'NIH'}, {'id': 'MILLENNIUM-WSU-2006-132', 'domain': 'Barbara Ann Karmanos Cancer Institute'}, {'id': 'WSU-HIC-060907M1F', 'type': 'OTHER', 'domain': 'Wayne State University - Human Investigation Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melphalan, Dexamethasone, Bortezomib,', 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4', 'interventionNames': ['Drug: bortezomib', 'Drug: dexamethasone', 'Drug: melphalan', 'Genetic: microarray analysis', 'Other: flow cytometry', 'Other: laboratory biomarker analysis', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'Bortezomib 1.3 mg/m2 days 1, 8, 15, 22', 'armGroupLabels': ['Melphalan, Dexamethasone, Bortezomib,']}, {'name': 'dexamethasone', 'type': 'DRUG', 'otherNames': ['Dexasone', 'Decadron', 'Diodex', 'Hexadrol', 'Maxidex', 'Dexamethasone Sodium Phosphate', 'Dexamethasone Acetate'], 'description': 'Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23', 'armGroupLabels': ['Melphalan, Dexamethasone, Bortezomib,']}, {'name': 'melphalan', 'type': 'DRUG', 'otherNames': ['Alkeran®', 'L-PAM', 'L-Sarcolysin', 'Phenylalanine Mustard'], 'description': 'Melphalan 9 mg/m2/day days 1-4', 'armGroupLabels': ['Melphalan, Dexamethasone, Bortezomib,']}, {'name': 'microarray analysis', 'type': 'GENETIC', 'description': '≤28 days prior to enrollment', 'armGroupLabels': ['Melphalan, Dexamethasone, Bortezomib,']}, {'name': 'flow cytometry', 'type': 'OTHER', 'description': 'Day 1 of cycles 6, 12, 18 and at end of study.', 'armGroupLabels': ['Melphalan, Dexamethasone, Bortezomib,']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': '≤28 days prior to enrollment', 'armGroupLabels': ['Melphalan, Dexamethasone, Bortezomib,']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'Start of each cycle', 'armGroupLabels': ['Melphalan, Dexamethasone, Bortezomib,']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers/Rocky Mountain Blood & Marrow Transplant Program', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Cancer Research Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201-1379', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Josephine Ford Cancer Center at Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Providence Cancer Institute at Providence Hospital - Southfield Campus', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Centers', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jeffrey A. Zonder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jeffrey Zonder', 'investigatorAffiliation': 'Barbara Ann Karmanos Cancer Institute'}}}}