{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.7","upperLimit":"94.7","value":"60.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"The proportion of subjects evaluated as response (CR + PR) was calculated.\n\nPR (Bladé) requires 1. or all of the others:\n\n1. Some, but not all, of the criteria for CR are fulfilled\n2. ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks.\n3. Reduction in 24 h urinary light chain excretion either by ≥90% or to \\<200 mg, maintained for a minimum of 6 weeks.\n4. For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks.\n5. ≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination).\n6. No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).","dispersionType":"95% Confidence Interval","groups":[{"description":"SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.","id":"OG000","title":"SyB L-0501 + Prednisolone"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 36 weeks","title":"Response Rate (Based on the Bladé Criteria)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}