{"groups":[{"description":"Four levels of dose were evaluated and a standard 3+3 dose escalation schema was used to determine the MTD and additional patients were evaluated on the MTD level.\n\n1. Level 1 1 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days\n2. Level 2 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days\n3. Level 3 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 20 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days\n4. Level 4 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 25 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days","id":"FG000","title":"Phase 1 Population"},{"description":"Each subject received the maximum planned dose of 1.3 mg/m2/IV bortezomib daily Days 1, 4, 8 and 11 followed by a 10-day rest period, 20 mg PO dexamethasone single daily oral dose Days 1, 2, 4, 5, 8, 9, 11, 12 and25 mg/PO/QD (every day)lenalidomide daily Days 1-14 followed by 7-day rest every 21 days x 4 cycles and then at 10 mg/day on the same schedule for cycles 5 - 8. Each cycle of treatment consisted of 21 days.","id":"FG001","title":"Phase 2 Pupulation"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"}],"type":"Going to transplant"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"11"}],"type":"remain on study"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Going non-protocol therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"necessity to increase lenalidomide dose"}],"milestones":[{"achievements":[{"comment":"Out of 33 enrolled, two patients went off study before start of therapy.","groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"35"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"5"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"30"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were screened over a two-week period.","recruitmentDetails":"A total of 68 patients were enrolled in the United States. For the phase I part, this study enrolled 33 eligible patients between Sep13, 2006 and Aug16, 2007. For the phase II part, this study enrolled 35 eligible patients between Aug 20, 2007 and Feb18, 2008."}