{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"52.2","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"The proportion of subjects evaluated as CR was calculated.\n\nCR (Bladé) requires all of the followings:\n\n1. Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.\n2. \\<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR.\n3. No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)\n4. Disappearance of soft tissue plasmacytomas","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":"CR Rate Based on the (Bladé) Criteria","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}