{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.0","upperLimit":"15.3","value":"2.1"},{"groupId":"OG001","lowerLimit":"1.0","upperLimit":"15.3","value":"2.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"description":"Duration from start of treatment to the first occurrence of a confirmed response of PR or better as assessed by the investigator. See definitions of response in Primary Outcome (ORR).","dispersionType":"Full Range","groups":[{"description":"Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.\n\nMelphalan flufenamide (Melflufen)\n\nDexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.","id":"OG000","title":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set"},{"description":"Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody","id":"OG001","title":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease"}],"paramType":"MEDIAN","populationDescription":"This outcome measure was pre-specified to be analyzed/reported for the Mel + Dex: FAS Arm/Group and \"Mel + Dex: Patients With TCR Disease.\n\nThis outcome measure was analyzed/reported for patients with a best response of PR or better in the full analysis set as well as in the sub-group of patients with triple class refractory disease.\n\nThis outcome measure was not analyzed/reported separately for the sub-group of patients with Extramedullary Disease. No data available to report for EMD patients.","reportingStatus":"POSTED","timeFrame":"From start of treatment to first confirmed response. Longest time to response in study recorded as 15.3 months.","title":"Time to Response","type":"SECONDARY","unitOfMeasure":"months"}