{"description":"Risk of zero relates to arm that did not have enrollment since all participants were transplant eligible","eventGroups":[{"deathsNumAffected":15,"deathsNumAtRisk":123,"description":"Cycle 1-Dexamethasone 40mg orally days 1/8/15/22; Lenalidomide 25mg orally days 1-21; Carfilzomib 20mg/m2 days 8/9 then 36mg/m2 venous days 15/16; Daratumumab 16mg/kg venous days 1/8/15/22 (KRd-Dara). Cycle 2 the same except Carfilzomib 36mg/m2 venous days 1/2/8/9/15/16. Cycles 3,4 the same but no Daratumumab Days 8 and 22. Dosage adjusted for last tolerated dose (LTD). Following induction therapy, auto-HCT is done (consolidation 1), then up to two 4-cycle blocks of KRd-Dara consolidation (consolidations 2 and 3). Minimum residual disease (MRD) checked after each phase. Patients with confirmed MRD(-) at or after consolidation 1 will not undergo maintenance and will be actively monitored for resurgence of MRD or clinical relapse. After consolidation if MRD+ patients will undergo standard of care lenalidomide maintenance.\n\nKRdD followed by auto-HCT: Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will be followed by autologous hematopoietic cell transplantation and KRdD consolidation.","id":"EG000","otherNumAffected":123,"otherNumAtRisk":123,"seriousNumAffected":14,"seriousNumAtRisk":123,"title":"KRdD Followed by Auto-HCT"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Cycle 1-Dexamethasone 40mg orally days 1/8/15/22; Lenalidomide 25mg orally days 1-21; Carfilzomib 20mg/m2 days 8/9 then @ 36mg/m2 venous days 15/16; Daratumumab 16mg/kg venous days 1/8/15/22. Cycle 2 the same except Carfilzomib 36mg/m2 venous days 1/2/8/9/15/16. Cycles 3,4 the same but no Daratumumab Day 22. Dosage adjusted for last tolerated dose (LTD). Following induction therapy, Following induction therapy, patients will receive up to three 4-cycle blocks of KRd-Dara consolidation (consolidations 1, 2 and 3). Minimum residual disease (MRD) checked after each phase. Patients with confirmed MRD(-) at or after consolidation 1 will not undergo maintenance and will be actively monitored for resurgence of MRD or clinical relapse. After consolidation if MRD+ patients will undergo standard of care lenalidomide maintenance.\n\nKRdD only: Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will not be followed by autologous hematopoietic cell transplantation but will proceed with KRdD consolidation.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"KRdD Only"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":123,"numEvents":51},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":123,"numEvents":34},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":123,"numEvents":23},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":123,"numEvents":69},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":68,"numAtRisk":123,"numEvents":68},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":123,"numEvents":50},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"maculopapular rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":123,"numEvents":49},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":123,"numEvents":48},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":123,"numEvents":45},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":123,"numEvents":43},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":123,"numEvents":35},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":123,"numEvents":34},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"infusion-related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":123,"numEvents":34},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":123,"numEvents":33},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":123,"numEvents":32},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"hypertension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Lung Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":123,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Thomboembolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"sudden death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Viral pneumonia"}],"timeFrame":"5 years"}