{"groups":[{"description":"Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.\n\nMelflufen: Intravenous infusion\n\nDexamethasone: Oral tablets","id":"FG000","title":"Arm A: Melflufen+Dexamethasone"},{"description":"Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.\n\nPomalidomide: Oral capsules\n\nDexamethasone: Oral tablets","id":"FG001","title":"Arm B: Pomalidomide+Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"3"}],"type":"Randomized But Not Treated"},{"reasons":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"170"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"40"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"9"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"11"}],"type":"Study Terminated by Sponsor"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"246"},{"groupId":"FG001","numSubjects":"249"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Patients were to receive treatment until there was documented disease progression, unacceptable toxicity, or the patient/treating physician determined it was not in the patient's best interest to continue. The study Sponsor terminated the study before all patients reached one of these endpoints. Shown here are the reasons for study treatment discontinuation.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"246"},{"groupId":"FG001","numSubjects":"249"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"246 patients were randomized to treatment Arm A, 249 patients to treatment Arm B (FAS). Of the 495 randomized patients, 228 patients in Arm A received treatment and 246 patients in Arm B received treatment (SAF). The protocol had pre-defined treatment criteria for specific laboratory values, and if the patient's values deteriorated between screening and C1D1, treatment could not be initiated. In total, 664 patients were screened, 495 randomized, 474 treated, 21 randomized but not treated.","recruitmentDetails":"The recruitment was performed from specialized clinics' own patient pool at 115 different treatment sites in the US, Europe and Asia (20 different countries). The first patient was recruited in 12-Jun-2017 and the last patient 25-Aug-2020."}