{"eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":28,"description":"Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.\n\ndaratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.\n\ncarfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16\n\nlenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days\n\ndexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16","id":"EG000","otherNumAffected":28,"otherNumAtRisk":28,"seriousNumAffected":16,"seriousNumAtRisk":28,"title":"Cohort 1"},{"deathsNumAffected":5,"deathsNumAtRisk":41,"description":"Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.\n\ndaratumumab: Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.\n\ncarfilzomib: Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16\n\nlenalidomide: Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days\n\ndexamethasone: Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15","id":"EG001","otherNumAffected":35,"otherNumAtRisk":41,"seriousNumAffected":14,"seriousNumAtRisk":41,"title":"Cohort 2"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":28},{"groupId":"EG001","numAffected":6,"numAtRisk":41}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":3,"numAtRisk":41}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric 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disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":28},{"groupId":"EG001","numAffected":11,"numAtRisk":41}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":28},{"groupId":"EG001","numAffected":6,"numAtRisk":41}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":28},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28},{"groupId":"EG001","numAffected":4,"numAtRisk":41}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28},{"groupId":"EG001","numAffected":0,"numAtRisk":41}],"term":"Atrial enlargement"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac 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polyps)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Carcinoid bronchial mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28},{"groupId":"EG001","numAffected":2,"numAtRisk":41}],"term":"Chest pain- cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth 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infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28},{"groupId":"EG001","numAffected":0,"numAtRisk":41}],"term":"Coronavirus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":28},{"groupId":"EG001","numAffected":9,"numAtRisk":41}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28},{"groupId":"EG001","numAffected":0,"numAtRisk":41}],"term":"Cutaneous candidiasis to bilateral axilla"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Decreased neutrophils"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Deep vein thrombosis (left leg)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28},{"groupId":"EG001","numAffected":1,"numAtRisk":41}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28},{"groupId":"EG001","numAffected":0,"numAtRisk":41}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric 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