{"groups":[{"description":"Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.","id":"FG000","title":"Lenalidomide and Dexamethasone (Rd)"},{"description":"Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.","id":"FG001","title":"Carfilzomib, Lenalidomide, and Dexamethasone (CRd)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}],"type":"Randomized but not treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"396"},{"groupId":"FG001","numSubjects":"396"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"389"},{"groupId":"FG001","numSubjects":"392"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"389"},{"groupId":"FG001","numSubjects":"392"}],"comment":"Completed represents patients who discontinued treatment as of 05 December 2017","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Eligible participants were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by β2 microglobulin level (\\< vs. ≥ 2.5 mg/L), prior bortezomib exposure (no vs. yes), and prior lenalidomide exposure (no vs. yes).","recruitmentDetails":"Participants were enrolled from 14 July 2010 to 15 March 2012. The primary analysis was conducted using a data cut-off date of 16 June 2014 and the final safety analysis after last subject last visit date (05 December 2017)."}