{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"74"},{"groupId":"OG003","value":"83"},{"groupId":"OG004","value":"96"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"35"},{"groupId":"OG003","value":"36"},{"groupId":"OG004","value":"24"}],"units":"Participants"}],"description":"Graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The maximum grade for each type of adverse event, regardless of causality, will be recorded. The percentage of patients that experience a grade 3 or higher adverse event will be reported by arm.","groups":[{"description":"Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A (Ixazomib Citrate and Dexamethasone)"},{"description":"Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm B (Ixazomib Citrate and Dexamethasone)"},{"description":"Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)"},{"description":"Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG003","title":"Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)"},{"description":"Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG004","title":"Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"2.5 years","title":"Incidence of Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage or patients"}