{"analyses":[{"groupDescription":"The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.87","pValueComment":"The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.","statisticalComment":"The log rank test was stratified on risk status (high risk vs. standard risk)","statisticalMethod":"Log Rank"},{"groupDescription":"The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.37","pValueComment":"The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.","statisticalComment":"The log rank test was stratified on risk status (high risk vs. standard risk)","statisticalMethod":"Log Rank"},{"groupDescription":"The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.27","pValueComment":"The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.","statisticalComment":"The log rank test was stratified on risk status (high risk vs. standard risk)","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"51.7","upperLimit":"64.6","value":"58.5"},{"groupId":"OG001","lowerLimit":"51.4","upperLimit":"63.7","value":"57.8"},{"groupId":"OG002","lowerLimit":"47.4","upperLimit":"60.0","value":"53.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"247"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"257"}],"units":"Participants"}],"description":"Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.","dispersionType":"95% Confidence Interval","groups":[{"description":"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance\n\nLenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.","id":"OG000","title":"Tandem Auto Transplant"},{"description":"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance\n\nlenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.","id":"OG001","title":"RVD Consolidation"},{"description":"Initial autologous transplant followed by lenalidomide maintenance\n\nLenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.","id":"OG002","title":"Lenalidomide Maintenance"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"38 months post-randomization","title":"Percentage of Participants With Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}