{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response).\n\nComplete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, \\<5% plasmas cells in marrow and no increase of lytic bone lesions.\n\nVery Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.\n\nPartial Response: \\>=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.\n\nMinimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other.","groups":[{"description":"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.\n\nPatients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.","id":"OG000","title":"Romidepsin + Bortezomib"}],"populationDescription":"Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.","reportingStatus":"POSTED","timeFrame":"up to month 8","title":"Kaplan Meier Estimate for Time to Response Assessed by the Investigator","type":"SECONDARY"}