{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"15"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"Participants will be evaluated for the safety of the vaccine, monitored and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for toxicity and adverse event reporting to the Food and Drug Administration. Dose limiting toxicity (DLT) is defined as grade 3 or higher toxicity. The only toxicities captured outside of the SAEs reported will be all grade 1-5 toxicites deemed definitely, probably, or possibly related to the vaccine portion of the study.","groups":[{"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":"OG000","title":"Arm 1 Vaccine"},{"description":"Patients receive standard of care treatment after autologous stem cell transplant\n\nStandard of care: No vaccines","id":"OG001","title":"Arm 2 Control"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"1 year","title":"Number of Participants Evaluated for Vaccine Safety","type":"PRIMARY","unitOfMeasure":"Participants"}