Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01355705
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2011-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C055866', 'term': 'amrubicin'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'C455861', 'term': 'pegfilgrastim'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}, {'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': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mliedtke@stanford.edu', 'phone': '650-498-6000', 'title': 'Michaela Liedtke, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks treatment, plus a minimum of 30 days follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Amrubicin + Lenalidomide + Dexamethasone', 'description': 'Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2', 'otherNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Deep venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Elevated AST/ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Muscle cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Graft vs host diseae (GvHD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Decreased ejection fraction (transient)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Progressive disease', 'notes': 'Hospitalization for infusional chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amrubicin + Lenalidomide + Dexamethasone', 'description': 'Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2'}], 'classes': [{'title': 'Complete Response (CR) rate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Very Good Partial Response (VGPR) Rate', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Total CR + VGPR', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response (PR) Rate', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}]}]}, {'title': 'Overall Response Rate (ORR = CR + VGPR + PR)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Modified International Myeloma Working Group Uniform Response Criteria:\n\nComplete (CR)=\n\n* Negative for monoclonal protein (MP) in urine (U) and serum (S) +\n* No tissue plasmacytomas (PC) +\n* \\<5% plasma cells (PCs) in marrow (M)\n\nStringent CR (sCR)= CR with normal light chain ratio+ no PCs in M\n\nNear CR (nCR)= CR, except MP persists in U and S\n\nPartial (PR)= S MP ≤50%, + U MP ≤90% or \\<200 mg/24 hours (hr)\n\nVery Good PR (VGPR)= in S MP ≤90%, + U MP \\<100 mg/24 hr\n\nMinimal (MR)=\n\n* S MP ≤51-75%, +\n* If light chain is excreted, reduced 50-89%/24 hr that is also \\>200 mg/24 hr, +\n* No increase in lytic bone lesions\n\nProgressive disease (PD)= any of:\n\n* S MP ≥125% and/or ≥+0.5 g/dL,\n* U MP ≥125% and/or ≥+200 mg/24 hr\n* New or increased bone lesions/PC\n* S calcium \\>11.5 mg/dL (attributed to increased PCs)\n\nPD after CR/sCR=\n\n* Reappearance of S or U MP\n* ≥5% clonal PCs in M\n* New PC, lytic bone lesions, hypercalcemia\n\nStable Disease (SD)= Not CR, VGPR, MR, PR, or PD', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amrubicin + Lenalidomide + Dexamethasone', 'description': 'Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2\n\nAmrubicin: 40, 60, or 80 mg/m2 intravenous (IV)\n\nLenalidomide: 15 mg daily by mouth\n\nDexamethasone: 40 mg weekly by mouth\n\nAspirin: 81 or 325 mg daily by mouth\n\nPegfilgrastim: 6 mg subcutaneous on Day 2'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000', 'lowerLimit': '129', 'upperLimit': '140'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '140 days', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amrubicin + Lenalidomide + Dexamethasone', 'description': 'Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '232'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '9 months', 'description': 'Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of:\n\n* Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline,\n* Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline\n* New or increased bone lesions or plasmacytomas\n* Serum calcium \\> 11.5 mg/dL (attributed to increased plasma cells)', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time-to-next Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amrubicin + Lenalidomide + Dexamethasone', 'description': 'Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '281'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '9 months', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amrubicin + Lenalidomide + Dexamethasone', 'description': 'Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'comment': '1 subject completed but was not evaluable.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Amrubicin + Lenalidomide + Dexamethasone', 'description': 'Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2011-05-16', 'resultsFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2011-05-17', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-11', 'studyFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria', 'timeFrame': '12 weeks', 'description': 'Modified International Myeloma Working Group Uniform Response Criteria:\n\nComplete (CR)=\n\n* Negative for monoclonal protein (MP) in urine (U) and serum (S) +\n* No tissue plasmacytomas (PC) +\n* \\<5% plasma cells (PCs) in marrow (M)\n\nStringent CR (sCR)= CR with normal light chain ratio+ no PCs in M\n\nNear CR (nCR)= CR, except MP persists in U and S\n\nPartial (PR)= S MP ≤50%, + U MP ≤90% or \\<200 mg/24 hours (hr)\n\nVery Good PR (VGPR)= in S MP ≤90%, + U MP \\<100 mg/24 hr\n\nMinimal (MR)=\n\n* S MP ≤51-75%, +\n* If light chain is excreted, reduced 50-89%/24 hr that is also \\>200 mg/24 hr, +\n* No increase in lytic bone lesions\n\nProgressive disease (PD)= any of:\n\n* S MP ≥125% and/or ≥+0.5 g/dL,\n* U MP ≥125% and/or ≥+200 mg/24 hr\n* New or increased bone lesions/PC\n* S calcium \\>11.5 mg/dL (attributed to increased PCs)\n\nPD after CR/sCR=\n\n* Reappearance of S or U MP\n* ≥5% clonal PCs in M\n* New PC, lytic bone lesions, hypercalcemia\n\nStable Disease (SD)= Not CR, VGPR, MR, PR, or PD'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR)', 'timeFrame': '140 days'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': '9 months', 'description': 'Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of:\n\n* Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline,\n* Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline\n* New or increased bone lesions or plasmacytomas\n* Serum calcium \\> 11.5 mg/dL (attributed to increased plasma cells)'}, {'measure': 'Time-to-next Treatment', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '29802551', 'type': 'DERIVED', 'citation': 'Dinner S, Dunn TJ, Price E, Coutre SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.'}]}, 'descriptionModule': {'briefSummary': 'To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES\n\n* Establish the maximum tolerated dose (MTD) and toxicity profile for the combination of amrubicin with lenalidomide and dexamethasone in previously treated adult patients with multiple myeloma during Phase I\n* Determine the combined rate of complete response (CR) and very good partial response (VGPR) for this combination in this population as defined by the International Myeloma Working Group Uniform Response Criteria (IMWGURC)\n\nSECONDARY OBJECTIVES\n\n* Determine the overall response rate (CR, VGPR and PR)\n* Assess additional evidence of ant-tumor activity as measured by duration of response (DOR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsed or refractory multiple myeloma that has progressed following at least 1 prior therapy.\n* Measurable disease defined as one of the following:\n\n * Serum M-protein ≥ 1 g/dL\n * Urine M-protein ≥ 200 mg/24 hours\n* Received at least 1 prior line of systemic treatment that may have included lenalidomide and/or an anthracycline.\n* No cytotoxic chemotherapy within 4 weeks prior to first dose of amrubicin. This interval may be reduced to 14 days for thalidomide, lenalidomide, bortezomib or corticosteroids, provided other entry criteria are met.\n* Age ≥ 18 at the time of consent.\n* Life expectancy of more than ≥ 3 months.\n* No known central nervous system involvement by myeloma.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 at study registration during phase 1. Once safety is confirmed, ECOG performance status 0 to 2 at study registration during phase 2.\n* No poorly-controlled intercurrent illness.\n* Platelets \\> 100 x 10\\^9/L\n* Hemoglobin \\> 8.0g/dL\n* Absolute neutrophil count (ANC) \\>1.5 x 10\\^9/L\n* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 x ULN\n* Calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by Echocardiogram (ECHO) or multiple gate acquisition scan (MUGA)\n* All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the Requirements of RevAssist.\n* Disease-free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.\n* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 U/mL within 10 to 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.\n* Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Able to take aspirin (81 or ≥ 25 mg) daily as prophylactic anticoagulation. Patients intolerant to aspirin may use warfarin or low molecular weight heparin (LMWH). Patients with previous thromboembolic event on lenalidomide or thalidomide may be started on warfarin or LMWH. Patients already taking warfarin or LMWH do not require additional aspirin..\n* Lactating females must agree not to breast-feed while taking lenalidomide\n\nExclusion Criteria:\n\n* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.\n* Pregnant or breastfeeding females.\n* Any concurrent severe or uncontrolled medical disease which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.\n* Use of any other experimental drug or therapy within 28 days of first dose of amrubicin.\n* Known hypersensitivity to thalidomide or lenalidomide.\n* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.\n* LVEF ≤ 50%.\n* Concurrent use of other anti-cancer agents or treatments.\n* Known positive for HIV, or infectious hepatitis, type B or C.\n* Cranial radiotherapy ≤ 21 days prior to first dose of amrubicin; radiotherapy to all other areas ≤ 7 days prior to first dose of amrubicin.'}, 'identificationModule': {'nctId': 'NCT01355705', 'briefTitle': 'Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Phase 1 Study of Amrubicin in Combination With Lenalidomide and Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'IRB-19092'}, 'secondaryIdInfos': [{'id': 'AR_MM_PI_007', 'type': 'OTHER', 'domain': 'Celgene Corporation'}, {'id': 'SU-05062011-7711', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': 'HEMMYL0018', 'type': 'OTHER', 'domain': 'OnCore ID'}, {'id': 'IRB-19092', 'type': 'OTHER', 'domain': 'Stanford IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amrubicin + Lenalidomide + Dexamethasone', 'description': 'Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2', 'interventionNames': ['Drug: Amrubicin', 'Drug: Lenalidomide', 'Drug: Dexamethasone', 'Drug: Aspirin', 'Drug: Pegfilgrastim']}], 'interventions': [{'name': 'Amrubicin', 'type': 'DRUG', 'otherNames': ['SM-5887'], 'description': '40, 60, or 80 mg/m2 intravenous (IV)', 'armGroupLabels': ['Amrubicin + Lenalidomide + Dexamethasone']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['CC-5013', 'Revlimid'], 'description': '15 mg daily by mouth', 'armGroupLabels': ['Amrubicin + Lenalidomide + Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron', 'Dexamethasone Intensol', 'Dexpak Taperpak'], 'description': '40 mg weekly by mouth', 'armGroupLabels': ['Amrubicin + Lenalidomide + Dexamethasone']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['acetylsalicylic acid'], 'description': '81 or 325 mg daily by mouth', 'armGroupLabels': ['Amrubicin + Lenalidomide + Dexamethasone']}, {'name': 'Pegfilgrastim', 'type': 'DRUG', 'otherNames': ['Neulasta', 'PEG-GCSF'], 'description': '6 mg subcutaneous on Day 2', 'armGroupLabels': ['Amrubicin + Lenalidomide + Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Michaela Liedtke', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michaela Liedtke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Medicine/Hematology', 'investigatorFullName': 'Michaela Liedtke', 'investigatorAffiliation': 'Stanford University'}}}}