{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator.\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.\n\nDisease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, \\>= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of 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 population. Analysis was not performed due to early termination of the study.","reportingStatus":"POSTED","timeFrame":"up to month 8","title":"Kaplan Meier Estimate for Time to Progression Assessed by the Investigator","type":"SECONDARY"}