{"analyses":[{"groupDescription":"Participants in sCR/CR at Randomization","groupIds":["OG000","OG001"],"nonInferiorityComment":"The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.","nonInferiorityType":"SUPERIORITY","pValue":"0.890","statisticalComment":"Statistical significance was determined using a pre-specified one-sided threshold of 0.05.","statisticalMethod":"Fisher Exact"},{"groupDescription":"The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants not in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.754","pValueComment":"Statistical significance was determined using a pre-specified one-sided threshold of 0.05.","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}],"title":"Stringent Complete Response (sCR)"},{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}],"title":"Complete Response (CR)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"title":"Very Good Partial Response (VGPR)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"title":"Partial Response (PR)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"title":"Stable Disease (SD)"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}],"title":"Progressive Disease (PD)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Participants in sCR/CR at Randomization"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}],"title":"Stringent Complete Response (sCR)"},{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}],"title":"Complete Response (CR)"},{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"}],"title":"Very Good Partial Response (VGPR)"},{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"title":"Partial Response (PR)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"title":"Stable Disease (SD)"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"title":"Progressive Disease (PD)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Participants Not in sCR/CR at Randomization"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"Response was assessed using the International Uniform Response Criteria. Best response is the best of all the disease response status at each assessment time point after randomization. The order from best to worst is: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All disease classifications are relative to the patient's disease status prior to allogeneic transplant (i.e. study entry). This outcome was compared between treatment groups using all response data up to 2 years post-transplant. These response data were summarized separately for patients in sCR/CR at the time of randomization vs. those who were not in sCR/CR at the time of randomization. Within each group (in sCR/CR vs not in sCR/CR at randomization), best response to treatment was compared between treatment groups using a Fisher's Exact test instead of a chi-square test because of the small sample size.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized participants were included in the analysis. Participants were divided into those in sCR/CR at the time of randomization vs. those who were not in sCR/CR at the time of randomization.","reportingStatus":"POSTED","timeFrame":"2 years post-transplant","title":"Percentage of Participants With Best Response to Treatment After Randomization","type":"SECONDARY","unitOfMeasure":"Participants"}