{"denoms":[{"counts":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"43"}],"units":"Participants"}],"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":"BG000","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":"BG001","title":"Placebo"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"35.3","upperLimit":"63.9","value":"52.6"},{"groupId":"BG001","lowerLimit":"44.9","upperLimit":"64.7","value":"57.5"},{"groupId":"BG002","lowerLimit":"35.3","upperLimit":"64.7","value":"55.9"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"23"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"20"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"37"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"38"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}],"title":"High Risk Multiple Myeloma"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"12"}],"title":"Standard Risk Multiple Myeloma"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"7"}],"title":"Primary Plasma Cell Leukemia"}]}],"description":"High risk multiple myeloma (MM) is defined as participants with any of the following chromosomal changes detected by fluorescence in situ hybridization (FISH): t(4;14), t(14;16), del (17p), and abnormalities of chromosome 1 (1q21 amplifications; 1p deletion); deletion 13 or hypodiploidy by cytogenetics.","paramType":"COUNT_OF_PARTICIPANTS","title":"Disease Classification","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"}],"title":"100"},{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"21"}],"title":"90"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"}],"title":"80"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}],"title":"70"}]}],"description":"KPS describes patient-perceived global quality of life and functioning on a scale of 0-100.\n\n100: No evidence of disease; 90: Normal activity. Minor signs or symptoms of disease; 80: Normal activity with effort. Some signs or symptoms of disease; 70: Cares for self. Unable to continue normal activity; 60: Needs occasional assistance, but cares for most personal needs; 50: Needs considerable assistance and medical care; 40: Disabled. Needs special care and assistance; 30: Severely disabled. Hospital admission indicated; 20: Very sick. Active supportive therapy needed; 10: Moribund; 0: Dead","paramType":"COUNT_OF_PARTICIPANTS","title":"Karnofsky Performance Score (KPS)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"17"}],"title":"Very Good Partial Response (VGPR)"},{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"19"}],"title":"Partial Response (PR)"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"}],"title":"Stable Disease or Progression"}]}],"description":"Measure Description: Very Good Partial Response (VGPR): Partial Response (PR), paraprotein decrease or \\>= 90% serum paraprotein decrease, and a 90% involved light chain decrease. PR: \\>= 50% serum monoclonal paraprotein decrease and 24 hr urinary monoclonal decrease, or \\>= 50% involved and uninvolved free light chain (FLC) decrease or a 50% decrease in involved FLC w/ 50% ratio decrease, or \\>= 50% BM plasma cells decrease, or \\>= 50% soft tissue plasmacytomas decrease. Stable Disease: none of above and no progression.","paramType":"COUNT_OF_PARTICIPANTS","title":"Disease Response","unitOfMeasure":"Participants"}],"populationDescription":"Participants who were transplanted and randomized are included."}