{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"16"}]}],"title":"Yes: Response Achieved at Four Cycles"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"11"}]}],"title":"No: Response Achieved at Four Cycles"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"27"}],"units":"Participants"}],"description":"Comparison to a historical control: The overall response rate (ORR) of each arm at 4 cycles (112 days) is compared to the historical RR of 30%. Arm A or Arm C is designed to detect an improved RR of 60% vs. 30% using Simon's 2-stage Optimum design with a power of at least 90% and an alpha error of 5%., respectively. For Arm B will achieve a power of at least 80% at the significance level of 0.05 to claim that Arm B has equivalent RR as the historical RR of 30% assuming an equivalence tolerance of +/- 20% when the true RR of Arm B is approximately 30%.\n\nResponse Rate is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.","groups":[{"description":"MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.\n\nDexamethasone: Given PO\n\nIxazomib: Given PO","id":"OG000","title":"Arm B (Ixazomib and Dexamethasone)"},{"description":"MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.\n\nDexamethasone: Given PO\n\nIxazomib: Given PO\n\nLenalidomide: Given PO","id":"OG001","title":"Arm C (Ixazomib, Dexamethasone, Lenalidomide)"},{"description":"UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.\n\nDexamethasone: Given PO\n\nIxazomib: Given PO","id":"OG002","title":"Arm A (Ixazomib and Dexamethasone)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"112 days","title":"The Primary Objective of the Study is to Test Whether the NFKB2 Rearrangement Can Guide the Selection of Treatment (Ixazomib Plus Dexamethasone (Id) or Ixazomib Plus Lenalidomide and Dexamethasone (IRd)) by Conducting the 3 Following Comparisons","type":"PRIMARY","unitOfMeasure":"Participants"}