{"groups":[{"description":"Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"FG000","title":"Arm A (Lenalidomide; Phase II)"},{"description":"Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"FG001","title":"Arm A (Lenalidomide; Phase III)"},{"description":"Patients undergo observation until progression to symptomatic myeloma.","id":"FG002","title":"Arm B (Observation; Phase III)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other complicating disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Alternative therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Changed hospital"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Never started treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Reason not reported"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"43"},{"groupId":"FG002","numSubjects":"0"}],"type":"Continuing lenalidomide"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"90"},{"groupId":"FG002","numSubjects":"92"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"88"},{"groupId":"FG002","numSubjects":"86"}],"type":"Received Treatment/Observation"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"86"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"90"},{"groupId":"FG002","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"Between January 2011 and January 2013, 44 patients were enrolled in the phase II safety run in portion of the study and were treated with lenalidomide as a single agent. Between February 2013 and July 2017, 182 patients were randomly assigned between the two treatment arms in the phase III portion of the study."}