{"groups":[{"description":"Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"FG000","title":"Lenalidomide+Dexamethasone"},{"description":"Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.","id":"FG001","title":"Dexamethasone"},{"description":"Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity.\n\nPatients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"FG002","title":"Crossover to Lenalidomide+Dexamethasone"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"98"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"95"},{"groupId":"FG002","numSubjects":"0"}],"type":"Eligible and Analyzable"},{"achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"94"},{"groupId":"FG002","numSubjects":"0"}],"type":"Safety Population"},{"achievements":[{"comment":"The study was closed early per recommedation of the Data Safety Monitoring Committee.","groupId":"FG000","numSubjects":"0"},{"comment":"The study was closed early per recommedation of the Data Safety Monitoring Committee.","groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"98"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Initial Randomization"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"See Crossover to Lenalidomide+Dexamethasone Arm.","groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"42"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"See Crossover to Lenalidomide+Dexamethasone Arm.","groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"40"}],"type":"Eligible and Analyzable"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"See Crossover to Lenalidomide+Dexamethasone Arm.","groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"40"}],"type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"See Crossover to Lenalidomide+Dexamethasone Arm.","groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"40"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Crossover to Lenalidomide+Dexamethasone"}],"recruitmentDetails":"Between October 15, 2004 and April 2, 2007, 198 patients were enrolled at 41 cooperative medical institutions."}