{"groups":[{"description":"Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.","id":"FG000","title":"Thalidomide + Dexamethasone"},{"description":"DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.","id":"FG001","title":"DOXIL + Thalidomide + Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"44"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"2"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"27"}],"type":"Transplant planned"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"13"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Enrollment at randomization","groupId":"FG000","numSubjects":"113"},{"comment":"Enrollment at randomization","groupId":"FG001","numSubjects":"112"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"110"},{"groupId":"FG001","numSubjects":"106"}],"type":"Received Study Medication"},{"achievements":[{"comment":"Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.","groupId":"FG000","numSubjects":"7"},{"comment":"Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.","groupId":"FG001","numSubjects":"12"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","numSubjects":"100"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 225 participants were randomnly assigned to treatment, 113 participants to the thal/dex group and 112 participants to the DOXIL/thal/dex group."}