{"groups":[{"description":"bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles","id":"FG000","title":"Cycle 1 to 4: Bortezomib + Dexamethasone (VD)"},{"description":"Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8","id":"FG001","title":"Stable Disease: Bortezomib + Dexamethasone (VD)"},{"description":"Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8","id":"FG002","title":"SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)"},{"description":"Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8","id":"FG003","title":"SD: Bortezomib+Dexamethasone+Lenalidomide (VDR)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"All participants started VD treatment for 4 cycles prior to local site response assessments","groupId":"FG000","numSubjects":"163"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"comment":"Of those completed, 120 subjects were assessed for response, 117 w/ Response or SD continued.","groupId":"FG000","numSubjects":"135"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Cycle 1 to 4"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Complete Response/Partial Response"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Protocol Violation"}],"milestones":[{"achievements":[{"comment":"Responding patients (not randomized) who received 4 more cycles of VD","groupId":"FG000","numSubjects":"98"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"4"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"63"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"4"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Randomization (Cycle 5) to Cycle 8"}],"preAssignmentDetails":"190 patients screened, 163 enrolled and received Bortezomib-Dexamethasone (VD) . Participants that completed cycles 1 to 4 were assessed for Response. Complete or Partial Responders were not randomized and continued on VD for cycles 5-8. Participants with Stable Disease (SD) were randomized to either VD, VDC, or VDR for cycles 5-8."}