{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"title":"VGR"},{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"1"}],"title":"PR"},{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"2"}],"title":"MR"},{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"21"}],"title":"SD"},{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"35"}],"title":"PD"},{"measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"25"}],"title":"NE"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"171"},{"groupId":"OG001","value":"84"}],"units":"Participants"}],"description":"Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \\>90% reduction in serum M-protein and urine M-protein \\<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \\<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \\>11.5 mg/dL; NE, not evaluable","groups":[{"description":"plitidepsin + dexamethasone combination\n\nplitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.","id":"OG000","title":"Plitidepsin+Dexamethasone"},{"description":"dexamethasone single agent\n\ndexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.","id":"OG001","title":"Dexamethasone"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years","title":"Best Overall Response (Independent Review Committee)","type":"SECONDARY","unitOfMeasure":"Participants"}