{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.4","upperLimit":"99.2","value":"66.7"},{"groupId":"OG001","lowerLimit":"29.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG002","lowerLimit":"78.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG003","lowerLimit":"35.9","upperLimit":"99.6","value":"83.3"},{"groupId":"OG004","lowerLimit":"71.2","upperLimit":"88.5","value":"80.9"},{"groupId":"OG005","lowerLimit":"75.1","upperLimit":"90.2","value":"83.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"89"},{"groupId":"OG005","value":"104"}],"units":"Participants"}],"description":"Clinical benefit rate was defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a 25% to 49% reduction in the level of serum M-protein or a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour, maintained for a minimum of 8 weeks.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG000","title":"Phase 1: Carfilzomib 45 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG001","title":"Phase 1: Carfilzomib 56 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG002","title":"Phase 1: Carfilzomib 70 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG003","title":"Phase 1: Carfilzomib 88 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG004","title":"Phase 2: Carfilzomib 70 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG005","title":"Phase 1+2: Carfilzomib 70 mg/m²"}],"paramType":"NUMBER","populationDescription":"Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).","reportingStatus":"POSTED","timeFrame":"Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.","title":"Clinical Benefit Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}