{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.42","upperLimit":"4.90","value":"4.27"},{"groupId":"OG001","lowerLimit":"1.97","upperLimit":"3.94","value":"2.89"},{"groupId":"OG002","lowerLimit":"3.09","upperLimit":"4.67","value":"3.94"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"119"}],"units":"Participants"}],"description":"Time from start of treatment to either progression or death, whichever comes first as assessed by the investigator using IMWG criteria. Progression of disease is defined by an increase of 25% from the lowest response for either of Serum M-component (absolute increase of ≥ 0.5 g/dL) or Urine M-component (absolute increase of ≥200 mg/ 24h); In patients without measurable M-protein a 25% increase in the difference between involved and uninvolved FLC (free light chain) levels (absolute increase must be \\>10 mg/dL); If unmeasurable FLC levels, a 25% increase in bone marrow plasma cell percentage (absolute percentage must be \\>10%); New bone or soft tissue plasmacytomas or definite increase in existing ones; Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder","dispersionType":"95% Confidence Interval","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":"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":"MEDIAN","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"Patients were followed until documented progression, unacceptable toxicity, patient/physician decision to withdraw or date of death, whichever came first. Longest follow-up time for PFS recorded as 37.2 months at study end.","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}