{"groups":[{"description":"Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7","id":"FG000","title":"Arm A (Melflufen+Dexamethasone+Daratumumab)"},{"description":"Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7","id":"FG001","title":"Arm B (Daratumumab)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"12"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"10"}],"type":"Study Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Patient Request"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Failed Criteria for Treatment Initiation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"27"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"26"}],"comment":"There were 6 randomized patients (5 in Arm A and 1 in Arm B) who never received treatment due to failure to meet treatment initiation criteria and/or consent withdrawal.","type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"27"}],"type":"NOT COMPLETED"}],"title":"Arm A/Arm B Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"There were 2 patients in Arm B who crossed over and received Melflufen+Dexamethasone+Daratumumab after a confirmed disease progression and received at least one dose of treatment.","groupId":"FG001","numSubjects":"2"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Crossover (Arm B)"}]}