Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-28 @ 5:28 AM
Study NCT ID:
NCT00112827
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2005-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000075122', 'term': 'Smoldering 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'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D017404', 'term': 'In Situ Hybridization, Fluorescence'}, {'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D017403', 'term': 'In Situ Hybridization'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pfrankel@coh.org', 'phone': '626-218-5265', 'title': 'Paul Frankel, Ph.D.', 'organization': 'City of Hope'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events occurred over a period of 14 years and 3 months.', 'description': '"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 33, 'seriousNumAtRisk': 36, 'deathsNumAffected': 20, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 4, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 85, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 28, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Lymphatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Conduction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Mobitz type I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Wolff-Parkinson-White syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'External ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Dry eye syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Flashing vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Constipation', 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'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Rash desquamating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks from start of treatment, up to 2 years', 'description': 'The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD.', 'unitOfMeasure': 'cGy', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients enrolled in the dose-finding portion of the study.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'OG001', 'title': 'Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'OG002', 'title': 'Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'OG003', 'title': 'Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'OG004', 'title': 'Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Evaluated after each course until completion of treatment.', 'description': 'Response defined as complete response or very good partial response. Complete response defined as the absence of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval. Thus all evidence of serum and urinary M-components must disappear on electrophoresis as well as by immunofixation studies. The follow-up bone marrow may not contain more than 5% plasma cells on aspiration or core biopsy and no evidence of increasing anemia. Skeletal X-rays must either show recalcification or no change in osteolytic lesions. Resolution of soft tissue plasmocytomas. Very good partial response defined as reduction of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval by greater than or equal to 90%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'comment': 'Upper 95% confidence interval was not reached.', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of treatment until the date of death from any cause, assessed up to 14 years', 'description': 'Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall survival was calculated for aggregated arms, due to small number of patients in most treatment arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'FG001', 'title': 'Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'FG002', 'title': 'Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'FG003', 'title': 'Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'FG004', 'title': 'Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'BG001', 'title': 'Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'BG002', 'title': 'Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'BG003', 'title': 'Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'BG004', 'title': 'Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)', 'description': 'See Detailed Description\n\ntotal marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy\n\nmelphalan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nfilgrastim: Given IV\n\nfluorescence in situ hybridization: Correlative studies\n\ncytogenetic analysis: Correlative studies\n\ncyclophosphamide: Given IV\n\nautologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation\n\nlenalidomide: Given orally'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '53'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '66'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '62'}, {'value': '54', 'groupId': 'BG003', 'lowerLimit': '31', 'upperLimit': '67'}, {'value': '54', 'groupId': 'BG004', 'lowerLimit': '36', 'upperLimit': '64'}, {'value': '54', 'groupId': 'BG005', 'lowerLimit': '31', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-10', 'size': 1023680, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-21T19:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2005-06-02', 'resultsFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2005-06-02', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-25', 'studyFirstPostDateStruct': {'date': '2005-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': '8 weeks from start of treatment, up to 2 years', 'description': 'The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD.'}, {'measure': 'Number of Subjects With Response', 'timeFrame': 'Evaluated after each course until completion of treatment.', 'description': 'Response defined as complete response or very good partial response. Complete response defined as the absence of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval. Thus all evidence of serum and urinary M-components must disappear on electrophoresis as well as by immunofixation studies. The follow-up bone marrow may not contain more than 5% plasma cells on aspiration or core biopsy and no evidence of increasing anemia. Skeletal X-rays must either show recalcification or no change in osteolytic lesions. Resolution of soft tissue plasmocytomas. Very good partial response defined as reduction of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval by greater than or equal to 90%.'}, {'measure': 'Overall Survival', 'timeFrame': 'From date of treatment until the date of death from any cause, assessed up to 14 years', 'description': 'Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Refractory Multiple Myeloma', 'Smoldering Multiple Myeloma', 'Stage I Multiple Myeloma', 'Stage II Multiple Myeloma', 'Stage III Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Melphalan, a chemotherapeutic agent, has been found to be an effective treatment choice for destroying myeloma cells, especially when given at high (bone marrow ablative) doses. Total marrow irradiation (TMI)/ablative dose radiation therapy is another modality capable of destroying myeloma cells. Autologous peripheral blood/stem cell transplant (ASCT) given after either melphalan or following TMI (aimed at the bone marrow containing areas of the skeleton, the site of origin of myeloma cells) will shorten the duration/alleviate the severity of both melphalan and marrow irradiation-associated side effects. Lenalidomide, an effective agent on its own right for the treatment of myeloma, has been shown to further enhance the beneficial effects of autologous stem cell transplants when given as maintenance therapy.\n\nPURPOSE: This previously phase I trial established the maximum tolerated dose of TMI at 1600 cGy. The phase II part of this study is ongoing and is studying the effects of high-dose melphalan and ASCT, followed by TMI and a second ASCT, with subsequent maintenance lenalidomide. The study is conducted in patients with stages I-III myeloma, with specific emphasis on assessing complete and very good partial response rate conversions, progression-free and overall survival, and safety/feasibility of delivering the planned treatment regimen.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the feasibility and toxicities of tandem cycle ablative therapy consisting first of high-dose melphalan and then escalating doses of fractionated total marrow irradiation (TMI) using helical tomotherapy in patients with advanced multiple myeloma.\n\nII. To establish the maximum tolerated dose of TMI using helical tomotherapy. III. To assess response rate, progression free and over-all survival following treatment with tandem cycle ablative therapy consisting first of high-dose melphalan and then escalating doses of TMI using helical tomotherapy with Dexamethasone/Thalidomide maintenance therapy in patients with advanced multiple myeloma.\n\nIV. To assess the feasibility of adding decadron and thalidomide as maintenance following the second cycle of high-dose therapy.\n\nSECONDARY OBJECTIVES:\n\nI. To perform cytogenetic, gene rearrangement, and fluorescence in situ hybridization (FISH) studies on baseline and post-treatment bone marrow and blood specimens and correlate the presence/persistence of these features with treatment outcome.\n\nII. To bank/develop cell lines developed for future investigations of tumor biology, and for potential assessment of efficacy of novel therapeutic agents.\n\nOUTLINE: This is a dose-escalation study of total marrow irradiation (TMI).\n\nPRIMING AND APHERESIS: Patients receive cyclophosphamide IV over 2 hours. Patients also receive filgrastim IV or subcutaneously daily beginning 24 hours after the administration of cyclophosphamide and continuing until apheresis is complete. Patients undergo apheresis until an adequate number of peripheral blood stem cells are collected.\n\nABLATIVE THERAPY:\n\nCourse 1: Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1. Patients then undergo autologous PBSC transplantation on day 0 and receive filgrastim IV or subcutaneously beginning on day 5 and continuing until blood counts recover.\n\nCourse 2: Beginning 6-18 weeks later, patients undergo TMI once or twice daily on days -4 to -1. Patients then undergo autologous peripheral blood stem cell transplant and receive filgrastim IV or subcutaneously beginning on day 5 and continuing until blood counts recover.\n\nMAINTENANCE THERAPY: Beginning within 6-8 weeks of day 0 of course 2 (TMI), patients receive oral lenalidomide daily. Courses repeat every 28 days for approximately 3 years in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed at 30 days, every 6 months for 1 year, and then annually for at least 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Criteria\n\n* Patients with multiple myeloma (stages I-III) will be eligible if they are either in response, or have stable disease\n* Patients with smoldering myeloma are eligible if there is evidence of progressive disease requiring therapy (\\>= 25% increase in M protein levels or Bence Jones excretion; Hgb =\\< 10.5 g/dl; frequent infections; hypercalcemia; rise in serum creatinine above normal on two separate occasion)\n* Patients with non-quantifiable monoclonal proteins are eligible provided they meet other criteria for multiple myeloma, or smoldering myeloma, and they have evaluable or measurable disease by other (radiographic) means\n* Unlimited prior chemotherapy regimens allowed\n* KPS \\>= 70%\n* Patients with Waldenstrom's macroglobulinemia are not eligible\n* Less than 18 months since diagnosis\n* No contraindication to the collection of a minimum of 4 x 10\\^6 CD34+ cells/kg by apheresis\n* All patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines\n* Adequate hepatic function as demonstrated by bilirubin, =\\< 1.5 mg/dl, and SGOT and SGPT \\< 2.5 x upper limits of normal\n* Adequate renal function as demonstrated by: creatinine of measured or calculated creatinine clearance of \\> 50 cc/min\n* Absolute neutrophil count of \\> 1000/ul, platelet count of \\> 100,000/ul\n* Cardiac ejection fraction \\>= 50% by MUGA scan and/or by echocardiogram\n* Adequate pulmonary function as demonstrated by FEV1 \\> 60% and DLCO \\> 50% of predicted lower limit\n* Hepatitis B antigen, Hepatitis C RNA and HIV antibody tests negative\n* No other medical, or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen\n* Females of reproductive age not using adequate birth control measures/ or who are pregnant are not eligible\n* History of other malignancies within the last 3 years, as long as patients have remained in complete remission for at least 2 years, except for non-melanoma skin cancer and in situ carcinoma of the cervix\n* Patients should have finished their prior chemotherapy at least 14 days prior to cyclophosphamide priming, and should have received their last dose of thalidomide, dexamethasone, or bisphosphonate \\> 10 days prior to cyclophosphamide priming\n* Pre-treatment tests must have been performed within 6 weeks prior to initiation of cyclophosphamide; A CBC, platelet count and comprehensive chemistry panel should be performed within 1 week prior to initiating cyclophosphamide priming\n* Known hypersensitivity to Filgrastim or to E. coli derived proteins is an exclusion\n* Inability to lie supine in a full body cast for approximately 30 minutes, the anticipated duration of each treatment session, is an exclusion\n* Previous radiation therapy to more than 20% of bone marrow containing areas, or to any area exceeding 2000 cGy, is an exclusion\n* Patients must be fully aware of the teratogenic potential of thalidomide and agree to fully comply with the mandated guidelines regarding contraception as stated in the informed consent and the patient warning document attached to the consent form\n* Women of childbearing potential must have a negative pregnancy test performed within 24 hours prior to beginning thalidomide, except for woman who have been postmenopausal for at least 2 years, or underwent hysterectomy\n* Use of effective means of contraceptive should be started at least 2 weeks prior to initiating thalidomide"}, 'identificationModule': {'nctId': 'NCT00112827', 'briefTitle': 'Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Tandem High-Dose Therapy With Melphalan and Total Marrow Irradiation (TMI) With Peripheral Blood Progenitor Cell Support and Lenalidomide Maintenance in Multiple Myeloma: A Phase I/II Trial', 'orgStudyIdInfo': {'id': '04064'}, 'secondaryIdInfos': [{'id': 'CDR0000428410', 'type': 'OTHER', 'domain': 'NCI PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'See Detailed Description', 'interventionNames': ['Radiation: total marrow irradiation', 'Drug: melphalan', 'Procedure: peripheral blood stem cell transplantation', 'Biological: filgrastim', 'Genetic: fluorescence in situ hybridization', 'Genetic: cytogenetic analysis', 'Drug: cyclophosphamide', 'Procedure: autologous-autologous tandem hematopoietic stem cell transplantation', 'Drug: lenalidomide']}], 'interventions': [{'name': 'total marrow irradiation', 'type': 'RADIATION', 'description': 'Undergo irradiation', 'armGroupLabels': ['Arm I']}, {'name': 'melphalan', 'type': 'DRUG', 'otherNames': ['Alkeran', 'CB-3025', 'L-PAM', 'L-phenylalanine mustard', 'L-Sarcolysin', 'Melfalan'], 'description': 'Given IV', 'armGroupLabels': ['Arm I']}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE', 'otherNames': ['PBPC transplantation', 'PBSC transplantation', 'peripheral blood progenitor cell transplantation', 'transplantation, peripheral blood stem cell'], 'description': 'Undergo transplantation', 'armGroupLabels': ['Arm I']}, {'name': 'filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['G-CSF', 'granulocyte colony-stimulating factor', 'Neupogen', 'r-metHuG-CSF', 'Recombinant Methionyl Human Granulocyte Colony Stimulating Factor'], 'description': 'Given IV', 'armGroupLabels': ['Arm I']}, {'name': 'fluorescence in situ hybridization', 'type': 'GENETIC', 'otherNames': ['fluorescence in situ hybridization (FISH)'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I']}, {'name': 'cytogenetic analysis', 'type': 'GENETIC', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['CPM', 'CTX', 'Cytoxan', 'Endoxan', 'Endoxana', 'Enduxan'], 'description': 'Given IV', 'armGroupLabels': ['Arm I']}, {'name': 'autologous-autologous tandem hematopoietic stem cell transplantation', 'type': 'PROCEDURE', 'description': 'Undergo transplantation', 'armGroupLabels': ['Arm I']}, {'name': 'lenalidomide', 'type': 'DRUG', 'otherNames': ['CC-5013', 'IMiD-1', 'Revlimid'], 'description': 'Given orally', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'George Somlo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}