{"analyses":[{"groupDescription":"The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.43","pValueComment":"The analysis involved pairwise comparisons of SPM 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":"Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)","statisticalMethod":"Gray's test"},{"groupDescription":"The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.70","pValueComment":"The analysis involved pairwise comparisons of SPM 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":"Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)","statisticalMethod":"Gray's test"},{"groupDescription":"The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.70","pValueComment":"The analysis involved pairwise comparisons of SPM 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":"Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)","statisticalMethod":"Gray's test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.2","upperLimit":"15.1","value":"10.8"},{"groupId":"OG001","lowerLimit":"4.9","upperLimit":"11.6","value":"7.9"},{"groupId":"OG002","lowerLimit":"4.3","upperLimit":"10.8","value":"7.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"247"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"257"}],"units":"Participants"}],"description":"This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period.\n\nThe development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms.","dispersionType":"95% Confidence Interval","groups":[{"description":"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance\n\nLenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.","id":"OG000","title":"Tandem Auto Transplant"},{"description":"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance\n\nLenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.","id":"OG001","title":"RVD Consolidation"},{"description":"Initial autologous transplant followed by lenalidomide maintenance\n\nLenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.","id":"OG002","title":"Lenalidomide Maintenance"}],"paramType":"NUMBER","populationDescription":"All 754 randomized BMT CTN 0702 participants are included in this analysis","reportingStatus":"POSTED","timeFrame":"5 years post-randomization in BMT CTN 0702","title":"Percentage of Participants With Secondary Primary Malignancies (SPM)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}