{"analyses":[{"ciLowerLimit":"-8.8","ciNumSides":"TWO_SIDED","ciPctValue":"80","ciUpperLimit":"14.6","groupDescription":"The proportion of patients alive and in CR/sCR at 1 year post transplant will be described in the vaccine and no vaccine groups with 80% confidence intervals and compared between groups using a two-sample Z test comparing binomial proportions.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3657","pValueComment":"A one-sided significance level of 0.10 is used to assess whether the vaccine appears promising relative to control.","paramType":"difference in the proportions","paramValue":"2.9","statisticalMethod":"Z test"},{"ciLowerLimit":"0.70","ciNumSides":"TWO_SIDED","ciPctValue":"80","ciUpperLimit":"2.03","estimateComment":"The Cochran-Mantel-Haenszel Odds Ratio estimate is for the Stratification. Stratum 1 is sCR/CR at Randomization. Stratum 2 is VGPR/PR/Stable Response at Randomization.","groupDescription":"A secondary analysis stratified on disease response prior to randomization between arms will be conducted using a Cochran-Mantel-Haenszel test, and a stratified odds ratio along with 80% confidence intervals will be estimated.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The stratified odds ratio is estimated with 80% confidence intervals.","nonInferiorityType":"EQUIVALENCE","pValue":"0.7461","pValueComment":"P-value is provided by Breslow-Day Test for Homogeneity of the Odds Ratios.","paramType":"Odds Ratio (OR)","paramValue":"1.19","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"-6.4","ciNumSides":"TWO_SIDED","ciPctValue":"80","ciUpperLimit":"20.6","groupDescription":"A secondary pairwise analysis of CR/sCR rates comparing the vaccine arm to Lenalidomide/GM-CSF arm at 1 year post transplant.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide/GM-CSF arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.","nonInferiorityType":"SUPERIORITY","pValue":"0.2429","paramType":"difference in the proportions","paramValue":"7.2","statisticalMethod":"Z test"},{"ciLowerLimit":"-15.6","ciNumSides":"TWO_SIDED","ciPctValue":"80","ciUpperLimit":"12.4","groupDescription":"A secondary pairwise analysis of CR rates comparing the vaccine arm to Lenalidomide alone arm at 1 year post transplant.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide alone arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.","nonInferiorityType":"SUPERIORITY","pValue":"0.4397","paramType":"difference in the proportions","paramValue":"-1.6","statisticalMethod":"Z test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44.5","upperLimit":"61.3","value":"52.9"},{"groupId":"OG001","lowerLimit":"41.6","upperLimit":"58.4","value":"50.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"68"}],"units":"Participants"}],"description":"The primary objective of this randomized trial is to compare the proportion of patients alive and in complete response (CR or sCR) at one year post transplant between patients receiving DC/myeloma vaccine/GM-CSF with lenalidomide maintenance therapy to those receiving lenalidomide maintenance therapy with or without GM-CSF. Complete Response (CR) is defined to require all the followings: Absence of the original monoclonal paraprotein in serum and urine by routine electrophoresis and by immunofixation; Less than 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed; No increase in size or number of lytic bone lesions on radiological investigations; Disappearance of soft tissue plasmacytomas. Stringent Complete Response (sCR) is defined to require all the followings in addition to CR: Normal free light chain ratio (FLC); Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.","dispersionType":"80% 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 primary analysis population includes all the randomized participants. Protocol defines primary analysis is to compare participants receiving vaccine vs those without vaccine. So no vaccine arms with or without GM-CSF are combined. Four participants withdrew consent to all study procedures before 1-year post-transplant. Of these, 2 cases on the Lenalidomide/GM-CSF arm and 2 cases on the Lenalidomide Alone arm. These participants were not evaluable for the primary endpoint and ERC confirmed.","reportingStatus":"POSTED","timeFrame":"1 year","title":"Percentage of Participants With 1-year Response Rate of CR/sCR","type":"PRIMARY","unitOfMeasure":"percentage of participants"}