{"groups":[{"description":"Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"FG000","title":"MPR+R"},{"description":"Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"FG001","title":"MPR+p"},{"description":"Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"FG002","title":"MPp+p"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"18"}],"type":"Ongoing in Double-blind Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"12"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"47"},{"groupId":"FG001","numSubjects":"81"},{"groupId":"FG002","numSubjects":"102"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"10"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Intent to treat population of all randomized participants","groupId":"FG000","numSubjects":"152"},{"groupId":"FG001","numSubjects":"153"},{"groupId":"FG002","numSubjects":"154"}],"type":"STARTED"},{"achievements":[{"comment":"Participants who took at least one dose of study drug.","groupId":"FG000","numSubjects":"150"},{"groupId":"FG001","numSubjects":"152"},{"groupId":"FG002","numSubjects":"153"}],"type":"Safety Population"},{"achievements":[{"comment":"Double-blind Treatment Period had no defined completion.","groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"152"},{"groupId":"FG001","numSubjects":"153"},{"groupId":"FG002","numSubjects":"154"}],"type":"NOT COMPLETED"}],"title":"Double-blind Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"25"}],"type":"Ongoing in Open Label Period"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"7"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"26"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"7"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"47"},{"groupId":"FG002","numSubjects":"72"}],"type":"STARTED"},{"achievements":[{"comment":"Participants continue until disease progression or other reason for discontinuing.","groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"47"},{"groupId":"FG002","numSubjects":"72"}],"type":"NOT COMPLETED"}],"title":"Open-label Extension"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"60"}],"type":"Ongoing in Follow-up Period"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"31"},{"groupId":"FG002","numSubjects":"24"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"4"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"comment":"66 participants from Double-blind and 9 from the Open Label Extension","groupId":"FG000","numSubjects":"75"},{"comment":"65 participants from the Double-blind and 25 from the Open Label Extension","groupId":"FG001","numSubjects":"90"},{"comment":"52 participants from the Double-blind and 36 from the Open Label Extension","groupId":"FG002","numSubjects":"88"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"75"},{"groupId":"FG001","numSubjects":"90"},{"groupId":"FG002","numSubjects":"88"}],"type":"NOT COMPLETED"}],"title":"Follow-up"}],"preAssignmentDetails":"Of the 606 subjects screened for this study, 147 failed screening. Reasons for screen failures included: laboratory values not met (45 subjects); diagnostic criteria for measurable multiple myeloma not met (30 subjects); other inclusion/exclusion criteria not met (30 subjects); subject withdrawal of consent (14 subjects); and other (28 subjects).","recruitmentDetails":"Data represents a May 11, 2010 data cut-off. The study is ongoing."}