{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Complete 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.\n\nStable Disease: Less than MR, but not PD\n\nProgressive Disease(PD):\\>25% increase in serum monoclonal paraprotein, or \\>25% plasma cells in marrow, or \\>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.","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 (ITT) population of patients defined as all patients who receive at least one dose of romidepsin and bortezomib. However efficacy data was not analyzed due to the early termination of the study.","reportingStatus":"POSTED","timeFrame":"up to 8 months","title":"Count of Participant Best Overall Response As Assessed by the Investigator","type":"PRIMARY"}