{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"}],"units":"Participants"}],"description":"ORR is defined as percentage of participants with complete response (CR) and partial response (PR) per International Myeloma Working Group (IMWG) criteria below.\n\n* CR = Negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas, and \\<5% plasma cells in bone marrow\n* Stringent CR = Above definition plus normal FLC ration and absence of clonal cells in bone marrow by IHC or 2-4 color flow cytometry\n* PR = At least 50% reduction of serum M-protein and reduction in 24 urinary M-protein by at least 90% or to \\<200 mg/24 h. If serum and urine M-protein unmeasurable, require at least 50% decrease in difference between involved and uninvolved FLC levels. If serum free light assay also unmeasurable, require at least 50% reduction in plasma cells, provided baseline was at least 30%\n* Very Good PR (VGPR) = Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or \\>90% reduction in serum M-protein plus urine M-protein level \\<100 mg/24 h","groups":[{"description":"\\- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle.\n\n* Oral:\n\n  * Ixazomib given weekly on days 1, 8, 15\n  * Dexamethasone given weekly during cycle\n* Infused:\n\n  * Nivolumab given once per cycle\n  * Cyclophosphamide given on days 1, 8, 15 during cycle\n\nNivolumab: Given intravenously once per cycle\n\nIxazomib: Given orally on days 1, 8, 15.\n\nDexamethasone: Given orally on days 1, 8, 15, 22\n\nCyclophosphamide: Given intravenously on days 1, 8, 15.","id":"OG000","title":"Nivolumab and Ixazomib"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"up to 8 months","title":"Objective Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}