{"groups":[{"description":"Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \\> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.","id":"FG000","title":"Lenalidomide and Low-Dose Dexamethasone (Rd)"},{"description":"Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \\> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.","id":"FG001","title":"Lenalidomide and Dexamethasone Rd18"},{"description":"Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.","id":"FG002","title":"Melphalan + Prednisone + Thalidomide (MPT)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"68"},{"groupId":"FG001","numSubjects":"71"},{"groupId":"FG002","numSubjects":"76"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"273"},{"groupId":"FG001","numSubjects":"362"},{"groupId":"FG002","numSubjects":"339"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"21"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"37"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"64"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"21"}],"type":"Study Close Out"},{"reasons":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"47"}],"type":"Miscellaneous"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"535"},{"groupId":"FG001","numSubjects":"541"},{"groupId":"FG002","numSubjects":"547"}],"type":"STARTED"},{"achievements":[{"comment":"Safety population = all randomized participants who received at least 1 dose of study treatment.","groupId":"FG000","numSubjects":"532"},{"comment":"Safety population = all randomized participants who received at least 1 dose of study treatment.","groupId":"FG001","numSubjects":"540"},{"comment":"Safety population = all randomized participants who received at least 1 dose of study treatment.","groupId":"FG002","numSubjects":"541"}],"type":"Safety Population"},{"achievements":[{"comment":"Participants randomized, but did not receive any study drug treatment.","groupId":"FG000","numSubjects":"3"},{"comment":"Participants randomized, but did not receive any study drug treatment.","groupId":"FG001","numSubjects":"1"},{"comment":"Participants randomized, but did not receive any study drug treatment.","groupId":"FG002","numSubjects":"6"}],"type":"Untreated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"535"},{"groupId":"FG001","numSubjects":"541"},{"groupId":"FG002","numSubjects":"547"}],"type":"NOT COMPLETED"}],"title":"Active Treatment Phase"},{"milestones":[{"achievements":[{"comment":"Includes participants who discontinued treatment for reasons other than progressive disease.","groupId":"FG000","numSubjects":"87"},{"comment":"Includes participants who completed 18 cycles (Rd18) and did not experience progressive disease.","groupId":"FG001","numSubjects":"300"},{"comment":"Includes participants who completed 12 cycles MPT and did not experience progressive disease.","groupId":"FG002","numSubjects":"273"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"87"},{"groupId":"FG001","numSubjects":"300"},{"groupId":"FG002","numSubjects":"273"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Progression Free Survival-PFS-Follow-Up"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"127"},{"groupId":"FG001","numSubjects":"188"},{"groupId":"FG002","numSubjects":"144"}],"type":"Continue in Long Term Follow Up"}],"milestones":[{"achievements":[{"comment":"Includes participants from both the active treatment phase and from the PFS follow-up phase.","groupId":"FG000","numSubjects":"382"},{"comment":"Includes participants from both the active treatment phase and from the PFS follow-up phase.","groupId":"FG001","numSubjects":"463"},{"comment":"Includes participants from both the active treatment phase and from the PFS follow-up phase.","groupId":"FG002","numSubjects":"459"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"255"},{"groupId":"FG001","numSubjects":"275"},{"groupId":"FG002","numSubjects":"315"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"127"},{"groupId":"FG001","numSubjects":"188"},{"groupId":"FG002","numSubjects":"144"}],"type":"NOT COMPLETED"}],"title":"Long-Term Follow Up Phase"}],"preAssignmentDetails":"Participants were stratified at randomization by 1) age (≤ 75 versus \\> 75 years), 2) stage (International Staging System Stages I or II versus Stage III), and 3) country.","recruitmentDetails":"This study was conducted in the Europe, Asia, North America and Pacific regions. Participants were randomized at 246 sites (165 in Europe, 23 in Asia, 39 in North America, and 19 in the Pacific). The study was co-sponsored by Intergroupe Francophone du Myélome (IFM) (for sites in France, Switzerland, and Belgium) and Celgene Corporation."}