{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"description":"Overall response rate, defines proportion of participants with Complete response (CR), Partial response (PR) or Minimal response (MR) as best response for all cycles. In atleast 2 determinations for minimum of 6 week (Wks) for every criteria listed. CR defined as disappearance of original monoclonal (MC) paraprotein (PP) in blood and urine on immunofixation determinations (IFD); \\< 5 % plasma cells in bone marrow; no increase in size or number of lytic bone lesions (LBLs); disappearance of soft tissue plasmacytomas (STP). PR defined as \\>= 50% reduction (RE) in level of serum MC PP for 2 IFDs; if present RE in 24 hour urinary light chain excretion (ULCE) by \\>= 90% RE or \\<200 mg; \\>= 50% RE in STP for; no increase in size or number of LBLs. MR criteria defined were \\>= 25% to \\<=49% RE serum MC PP; if present 50 to 89% RE in 24 hour LCE exceeding 200 mg/24 hour; 25% to 49% RE in size of STP; no increase in size or number of LBLs.","groups":[{"description":"The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.","id":"OG000","title":"SRT501 Monotherapy"},{"description":"The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.","id":"OG001","title":"SRT501 + Bortezomib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Modified Intent to Treat (mITT), had participants who completed first (2) cycles of SRT501 monotherapy. Participants dropped were not counted; those withdrew after 2nd cycle were considered evaluable regardless of discontinuation reason; alongwith participants discontinued for missing clinical trial material after 2 cycle, were considered.","reportingStatus":"POSTED","timeFrame":"Approximately up to 12 cycles of 3 weeks","title":"Number of Participants With Overall Response Rate","type":"PRIMARY","unitOfMeasure":"Participants"}