{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"35"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"119"}],"units":"Participants"}],"description":"The overall response rate (ORR) will be estimated as the percentage of patients who achieve sCR, CR, VGPR, or PR as their best response as assessed by the investigator. Response assessed by IMWG (International myeloma working group) criteria sCR-stringent complete response: CR plus Normal FLC (free light chain) ratio and absence of clonal cells in BM CR-complete response: Negative immunofixation in serum/urine; Disappearance of soft tissue plasmacytomas; \\<5% plasma cells in BM; If only FLC disease, normal FLC ratio (0.26-1.65) VGPR-very good partial response: Serum/urine M-protein detectable by immunofixation but not electrophoresis or ≥90% reduction in serum M-protein and urine M-protein \\<100 mg/24 h; If only FLC disease, \\>90% decrease in the difference between involved and uninvolved FLC levels PR-partial response: 50% reduction of serum M-protein and soft tissue plasmacytomas, ≥90% reduction in urinary M-protein or to \\<200 mg/24 h; other special cases if M-protein unmeasurable","groups":[{"description":"Full analysis set\n\nMelphalan 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":"Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass","id":"OG001","title":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease"},{"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":"OG002","title":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Patients were followed until documented progression, unacceptable toxicity, patient/physician decision to withdraw or date of death, whichever came first. Longest time to response in study recorded as 15.3 months. Longest time on treatment 35 months.","title":"Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"Participants"}