{"analyses":[{"groupDescription":"The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide/GM-CSF arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.308","pValueComment":"Statistical significance was determined using a pre-specified threshold of 0.05","statisticalMethod":"Log Rank"},{"groupDescription":"The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide alone arm.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.990","pValueComment":"Statistical significance was determined using a pre-specified threshold of 0.05","statisticalMethod":"Log Rank"},{"groupDescription":"The null hypothesis is that there is no difference of overall Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.303","pValueComment":"Statistical significance was determined using a pre-specified threshold of 0.05","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"88.6","upperLimit":"99.2","value":"97"},{"groupId":"OG001","lowerLimit":"100","upperLimit":"100","value":"100"},{"groupId":"OG002","lowerLimit":"79.8","upperLimit":"99.6","value":"96.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"description":"This is the pairwise comparison for percentage of participants with Overall Survival. Death from any cause is considered as events for this endpoint. The time to event is calculated as time from randomization to death, loss to follow-up or the end of the study, whichever comes first. Patients alive at the time of last observation are considered censored. The Kaplan-Meier estimator will be constructed for each treatment arm. Overall survival are compared between the vaccine arm, lenalidomide/GM-CSF arm and lenalidomide alone arm from 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 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 and GM-CSF"},{"description":"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide.\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.","id":"OG002","title":"Maintenance Lenalidomide"}],"paramType":"NUMBER","populationDescription":"The randomized participants are included in the analysis","reportingStatus":"POSTED","timeFrame":"2 years","title":"Percentage of Participants With Overall Survival in Pairwise Analysis","type":"SECONDARY","unitOfMeasure":"percentage of participants"}