{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"59.9","upperLimit":"89.6","value":"77.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"}],"units":"Participants"}],"description":"To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better.\n\nPartial response is defined as a dFLC decrease of ≥ 50%, but remaining \\> 4.0 mg/dL.\n\nVery good partial response is defined as the difference between involved and uninvolved FLCs \\[dFLC\\] \\< 4.0 mg/dL.\n\nComplete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Isatuximab"}],"paramType":"NUMBER","populationDescription":"35 participants who received treatment and are analyzable.","reportingStatus":"POSTED","timeFrame":"From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years","title":"Assess Efficacy by Confirmed Overall Hematologic Response","type":"PRIMARY","unitOfMeasure":"percentage of paticipants"}