{"groups":[{"description":"Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \\> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.","id":"FG000","title":"Pomalidomide Plus Low-Dose Dexamethasone"},{"description":"Participants received 40 mg dexamethasone (participants \\> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.","id":"FG001","title":"High-Dose Dexamethasone (HD-Dex)"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"302"},{"groupId":"FG001","numSubjects":"153"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"300"},{"groupId":"FG001","numSubjects":"150"}],"type":"Received Study Drug"},{"achievements":[{"comment":"Not applicable to participants initially randomized to receive pomalidomide","groupId":"FG000","numSubjects":"0"},{"comment":"After Amendment 4 participants still on HD-Dex treatment were permitted to crossover to pomalidomide","groupId":"FG001","numSubjects":"11"}],"type":"Crossed-over to Pomalidomide"},{"achievements":[{"groupId":"FG000","numSubjects":"302"},{"groupId":"FG001","numSubjects":"153"}],"comment":"Completed represents participants who discontinued from study treatment","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Treatment Phase"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"8"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"0"}],"comment":"After Amendment 4 participants still on HD-Dex treatment were permitted to crossover to pomalidomide","type":"Crossed-over to Pomalidomide"},{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"8"}],"comment":"Completed represents participants who discontinued from PFS follow-up","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"PFS Follow-up Phase"}],"preAssignmentDetails":"Participants were randomized in a 2:1 ratio. Treatment phase discontinuation occurred when a participant had confirmed progressive disease. Participants who did not progress but who were intolerant to treatment, or no longer wished to receive study treatment entered the progression-free survival (PFS) follow-up period until disease progression.","recruitmentDetails":"The study was conducted at 93 sites: 68 sites in Europe, 10 sites in Australia, 10 sites in Canada, 4 sites in Russia, and 1 site in the United States (US) from 18 March 2011 to 29 August 2017."}