{"eventGroups":[{"deathsNumAffected":12,"deathsNumAtRisk":13,"description":"This is a prospective, two-arm phase I randomized trial. Patients will be accrued only from and treated at MSKCCand The Rockefeller University/Center for Clinical \\& Translational Science . The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Twenty patients will accrue to the study and ten will receive vaccines at 9x10\\^6 LCs per dose (i.e., combination of 3x10\\^6 CT7 mRNA-electroporated LCs + 3x10\\^6 MAGE-A3 mRNA-electroporated LCs + 3x10\\^6 WT1 mRNA-electroporated LCs) and another ten who will not receive any LC vaccines but will otherwise undergo identical cytoreduction, ASCT, and standard supportive care. At approximately 3 months after ASCT and as deemed clinically appropriate, patients will start lenalidomide maintenance therapy, which is now standard to delay disease progression.\n\nCT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs): Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant. Patients on the vaccine arm of the study will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after ASCT followed by two boosters at days +30 and +90. Vaccines will be dosed at 9x10\\^6 LCs per vaccine x 3.","id":"EG000","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":3,"seriousNumAtRisk":13,"title":"Arm 1 Vaccine"},{"deathsNumAffected":8,"deathsNumAtRisk":15,"description":"Patients receive standard of care treatment after autologous stem cell transplant\n\nStandard of care: No vaccines","id":"EG001","otherNumAffected":15,"otherNumAtRisk":15,"seriousNumAffected":2,"seriousNumAtRisk":15,"title":"Arm 2 Control"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":4,"numAtRisk":15}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":15}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":15}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":15}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13},{"groupId":"EG001","numAffected":5,"numAtRisk":15}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":13},{"groupId":"EG001","numAffected":11,"numAtRisk":15}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":13},{"groupId":"EG001","numAffected":11,"numAtRisk":15}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":13},{"groupId":"EG001","numAffected":10,"numAtRisk":15}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":13},{"groupId":"EG001","numAffected":11,"numAtRisk":15}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":15}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":15}],"term":"Rash maculo-papular"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":15}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":15}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":15}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":15}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":15}],"term":"Resp, thoracic & mediastinal disorder Other, spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":15}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":15}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":15}],"term":"Lung infection"}],"timeFrame":"1 year"}