{"groups":[{"description":"Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.","id":"FG000","title":"Lenalidomide Plus Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"29"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"23"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Intolerance of therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Lack of compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Lymphocytes infusion"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"End of therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"6"}],"type":"Not treated with lenalidomide"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"150"}],"type":"STARTED"},{"achievements":[{"comment":"6 enrolled participants did not receive lenalidomide.","groupId":"FG000","numSubjects":"144"}],"type":"Safety and Full Analysis Set (FAS)"},{"achievements":[{"comment":"10 participants had \\>= 6 months and 63 participants \\< 6 months treatment prior to study termination.","groupId":"FG000","numSubjects":"73"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"77"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"A total of 150 participants in 37 sites in Germany were enrolled when lenalidomide became commercially available in Germany. Study completion (end of study) was the time point when participants discontinued study drug and could switch to commercial lenalidomide."}