{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":33,"description":"All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm.\n\nDaratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after.\n\nDexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.","id":"EG000","otherNumAffected":31,"otherNumAtRisk":33,"seriousNumAffected":4,"seriousNumAtRisk":33,"title":"A: Daratumumab & Dexamethasone"},{"deathsNumAffected":1,"deathsNumAtRisk":12,"description":"Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle.\n\nDaratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after.\n\nDexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.\n\nLenalidomide Pill: Lenalidomide will be given orally on days 1-21 of a 28 days cycle.\n\nSpecifically patients with a creatinine clearance ≥ 50 ml/min will receive 25 mg of lenalidomide PO Days 1-21. Patients with a creatinine clearance ≥ 30 but less than 50 ml/min will receive 10 mg of lenalidomide.\n\nPatients with a creatinine clearance \\< 30 ml/min are not eligible but patients who experience a deterioration in the renal function during screening or treatment may continue on lenalidomide therapy as long as the risk / benefit profile is deemed acceptable.","id":"EG001","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":6,"seriousNumAtRisk":12,"title":"B: Daratumumab, Dexamethasone and Lenalidomide"},{"deathsNumAffected":0,"deathsNumAtRisk":7,"description":"Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m\\^2 Days 1,8 and 15 of each 28 day treatment cycle.\n\nDaratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after.\n\nDexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.\n\nBortezomib Injection: Bortezomib will be given weekly subcutaneously in an effort to decrease the toxicity of the therapy. Specifically patients will receive a starting dose of bortezomib of 1.3 mg/m\\^2 Days 1,8,15 of a 28 day cycle. Bortezomib will be administered in the cancer center per standard of care procedures.","id":"EG002","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":2,"seriousNumAtRisk":7,"title":"C: Daratumumab, Dexamethasone and Bortezomib"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":33,"numEvents":106},{"groupId":"EG001","numAffected":8,"numAtRisk":12,"numEvents":51},{"groupId":"EG002","numAffected":6,"numAtRisk":7,"numEvents":32}],"term":"Investigations, Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":33,"numEvents":33},{"groupId":"EG001","numAffected":5,"numAtRisk":12,"numEvents":7},{"groupId":"EG002","numAffected":4,"numAtRisk":7,"numEvents":11}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":33,"numEvents":14},{"groupId":"EG001","numAffected":5,"numAtRisk":12,"numEvents":13},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":33,"numEvents":10},{"groupId":"EG001","numAffected":7,"numAtRisk":12,"numEvents":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":3}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":12,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":12,"numEvents":9},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":2}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":12,"numEvents":13},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":5}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":13},{"groupId":"EG001","numAffected":2,"numAtRisk":12,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":7},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":2}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hemoglobin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":33,"numEvents":45},{"groupId":"EG001","numAffected":10,"numAtRisk":12,"numEvents":27},{"groupId":"EG002","numAffected":3,"numAtRisk":7,"numEvents":8}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":33,"numEvents":19},{"groupId":"EG001","numAffected":6,"numAtRisk":12,"numEvents":12},{"groupId":"EG002","numAffected":4,"numAtRisk":7,"numEvents":7}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":7},{"groupId":"EG001","numAffected":8,"numAtRisk":12,"numEvents":21},{"groupId":"EG002","numAffected":3,"numAtRisk":7,"numEvents":3}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":33,"numEvents":18},{"groupId":"EG001","numAffected":6,"numAtRisk":12,"numEvents":13},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":33,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":7,"numEvents":6}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":33,"numEvents":8},{"groupId":"EG001","numAffected":5,"numAtRisk":12,"numEvents":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":2}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":33,"numEvents":16},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":7,"numEvents":10}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":33,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hyperphosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Metabolism and nutrition disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":2}],"term":"Hyperlipidemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":2}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":33,"numEvents":10},{"groupId":"EG001","numAffected":9,"numAtRisk":12,"numEvents":41},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":3}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":33,"numEvents":10},{"groupId":"EG001","numAffected":5,"numAtRisk":12,"numEvents":9},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":33,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":12,"numEvents":7},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":2}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":12,"numEvents":7},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":12,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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Per Protocol, Adverse Events are collected from \"On Treatment\" date to 30 days after \"Off Treatment\" date (on average of 2 years)"}