{"groups":[{"description":"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.\n\nPulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.","id":"FG000","title":"Lenalidomide Plus Dexamethasone (Len/Dex)"},{"description":"Placebo PO daily on Days 1 to 28 of each 28 day cycle.\n\nPulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.\n\nParticipants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.\n\nAfter the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.","id":"FG001","title":"Placebo Plus Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"12"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"67"},{"groupId":"FG001","numSubjects":"122"}],"type":"Progression of disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lack of therapeutic effect"},{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"10"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"176"},{"groupId":"FG001","numSubjects":"175"}],"type":"STARTED"},{"achievements":[{"comment":"Includes those who took at least one dose of study medication regimen","groupId":"FG000","numSubjects":"176"},{"comment":"Includes those who took at least one dose of study medication regimen","groupId":"FG001","numSubjects":"175"}],"type":"Safety Population"},{"achievements":[{"comment":"1 participant excluded because they had no baseline M-protein assessment","groupId":"FG000","numSubjects":"175"},{"comment":"4 participants excluded because they had no baseline M-protein assessment","groupId":"FG001","numSubjects":"171"}],"type":"Evaluable Population"},{"achievements":[{"comment":"54 participants ongoing and continuing on lenalidomide/dexamethasone treatment","groupId":"FG000","numSubjects":"54"},{"comment":"Ongoing and includes 15 participants who crossed over to lenalidomide/dexamethasone after unblinding","groupId":"FG001","numSubjects":"19"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"122"},{"groupId":"FG001","numSubjects":"156"}],"type":"NOT COMPLETED"}],"title":"Blinded Treatment (Up to 03 Aug 2005)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"12"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"128"}],"type":"Progression of disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"11"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Refers to original treatment group assignment in the study.","groupId":"FG000","numSubjects":"176"},{"groupId":"FG001","numSubjects":"175"}],"type":"STARTED"},{"achievements":[{"comment":"Participants completed = those continuing on long term Lenalidomide and dexamethasone","groupId":"FG000","numSubjects":"21"},{"comment":"Participants completed = those continuing on long term dexamethasone","groupId":"FG001","numSubjects":"8"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"167"}],"type":"NOT COMPLETED"}],"title":"On Study at Time of Unblinding"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"4"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"}],"type":"Progression of Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"comment":"2 participants opted to receive dex alone, 3 crossed over to Len/Dex and 3 added Len at a later date","groupId":"FG001","numSubjects":"8"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"8"}],"type":"NOT COMPLETED"}],"title":"Long Term Extension (Up to 25 Jun 2013)"}],"preAssignmentDetails":"A pre-specified interim analysis revealed a highly significant benefit favoring the lenalidomide/dexamethasone regimen, crossing the pre-specified O'Brien-Fleming superiority boundary. A decision was made to unblind the study allowing those receiving Placebo/dexamethasone to receive the lenalidomide/dexamethasone regimen.","recruitmentDetails":"The study was conducted at 55 sites in Australia, Europe, and Israel. Eligible participants were randomized in a 1:1 ratio to: lenalidomide plus oral pulse high-dose dexamethasone or Placebo plus oral pulse high-dose dexamethasone."}