{"groups":[{"description":"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).\n\nINDUCTION THERAPY: Patients receive melphalan 9 mg/m\\^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression.","id":"FG000","title":"Arm I (MPT-T)"},{"description":"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).\n\nINDUCTION THERAPY: Patients receive melphalan 5 mg/m\\^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.","id":"FG001","title":"Arm II (mPR-R)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"}],"type":"Never started protocol therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"15"}],"type":"Still on treatment at time of analysis"},{"reasons":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"53"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"55"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"12"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}],"type":"Alternative therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other Complicating Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Administrative Closure"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"154"},{"groupId":"FG001","numSubjects":"152"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"148"},{"groupId":"FG001","numSubjects":"150"}],"type":"Started Protocol Therapy"},{"achievements":[{"comment":"Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.","groupId":"FG000","numSubjects":"0"},{"comment":"Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.","groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"154"},{"groupId":"FG001","numSubjects":"152"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"The study was activated on February 29, 2008 and closed to accrual on November 30, 2011 with final accrual of 306 patients."}