{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}],"title":"PR"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"MR"},{"measurements":[{"groupId":"OG000","value":"5"}],"title":"SD"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"PD"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"description":"Partial response (PR): ≥50% reduction in serum M-protein and reduction of 24-hour urine M-protein by 90% or to \\<200 mg/24h Minimal response (MR): ≥25% but ≤49% reduction of serum M-protein and reduction of 24h urine M-protein 50-89%.\n\nProgressive disease (PD): 25% increase from the lowest response value in any of the following: serum M-protein, urine M-protein, BM plasma cell percentage, or difference in the kappa and lambda FLC. PD also diagnosed when an increase size or new bone lesions Stable disease (SD): not meet the criteria for PR, MR or PD Primary analysis should have been done once a total of 64 patients have received plitidepsin+BTZ+DXM with one futility analysis planned after the inclusion of 20 evaluable patients that had completed two full treatment cycles. Only 10 patients were treatedand 8 evaluable for the primary endpoint (ORR according to IMWG criteria). As a result of slow patient accrual, the study was closed before reaching the target enrollment","groups":[{"description":"Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.","id":"OG000","title":"Experimental"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"1 died without any valid tumor assessment done\n\n1 discontinued treatment-related AEs","reportingStatus":"POSTED","timeFrame":"From the date of first drug administration to the date of at least one disease assessment, up to 100 weeks","title":"Overall Response","type":"PRIMARY","unitOfMeasure":"Participants"}