{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0","value":"0"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"0","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"TRM is defined as death occurring in a patient from causes other than disease relapse or progression. Disease progression is the competing event for TRM. Patients alive without disease progression at last contact are considered censored for this event. TRM from time of randomization will be compared between vaccine and no-vaccine arms combined starting at time of randomization.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF.\n\nTumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation.\n\nAutologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10\\^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m\\^2 at the schedule and timing according to institutional practices.\n\nLeukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.\n\nLenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.\n\nMyeloma vaccine: The target dose is 3 x 10\\^6 fusion cells per vaccine. A minimum of 3 x 10\\^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance.\n\nGM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle.","id":"OG000","title":"Lenalidomide, Vaccine, and GM-CSF"},{"description":"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with or without GM-CSF.\n\nTumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).\n\nAutologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\\^6 CD34+ cells/kg patient actual body weight per autologous transplantation.\n\nMelphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\\^2 at the schedule and timing according to institutional practices.\n\nLenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.\n\nGM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.","id":"OG001","title":"Lenalidomide With or Without GM-CSF"}],"paramType":"NUMBER","populationDescription":"The randomized participants are included in the analysis","reportingStatus":"POSTED","timeFrame":"2 years","title":"Percentage of Participants With Treatment-related Mortality (TRM)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}