{"analyses":[{"groupDescription":"The null hypothesis is that there is no difference in the proportions of participants with treatment-related mortality between the Ixazomib and Placebo arms during 21 months post-randomization, with progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.173","pValueComment":"Statistical significance was determined using a pre-specified one-sided threshold of 0.05.","statisticalMethod":"Gray's Test"}],"classes":[{"categories":[{"measurements":[{"comment":"Because there were no events, the confidence interval was not calculated.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"comment":"Because there were no events, the confidence interval was not calculated.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0"}]}],"title":"12 Months Post-randomization"},{"categories":[{"measurements":[{"comment":"Because there were no events, the confidence interval was not calculated.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"groupId":"OG001","lowerLimit":"0.5","upperLimit":"16.5","value":"4.5"}]}],"title":"21 Months Post-randomization"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"Treatment-related mortality is defined as death occurring in a patient from causes other than disease relapse or progression. The cumulative incidence of treatment-related mortality (TRM) post-randomization is estimated for each treatment arm using the Aalen-Johansen estimator, with progression treated as a competing risk. Participants who were event-free at two years post-transplant are censored at that time. Confidence intervals for values of 0% were not calculated.","dispersionType":"90% Confidence Interval","groups":[{"description":"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance\n\nAllogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.\n\nFludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.\n\nMelphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.\n\nBortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.\n\nIxazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.","id":"OG000","title":"Ixazomib Maintenance"},{"description":"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.\n\nAllogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.\n\nFludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.\n\nMelphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.\n\nBortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.\n\nPlacebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"All randomized participants were included in the analysis.","reportingStatus":"POSTED","timeFrame":"12 months and 21 months post-randomization","title":"Percentage of Participants With Treatment-Related Mortality (TRM)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}