{"groups":[{"description":"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.\n\nBeyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.","id":"FG000","title":"Lenalidomide, Dexamethasone, Bortezomib Combination"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"11"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Initiation of non-protocol therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Treatment delay"}],"milestones":[{"achievements":[{"comment":"1 patient who never started treatment was excluded in the analysis.","groupId":"FG000","numSubjects":"64"}],"type":"STARTED"},{"achievements":[{"comment":"This included patients who completed at least 8 cycles of combination therapy with all drugs.","groupId":"FG000","numSubjects":"42"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"22"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants screened over a 3 week period.","recruitmentDetails":"65 eligible participants were enrolled from the 6 institutions in the United States between September 2006 and April 2008 and 64 out of 65 received protocol treatment."}