{"groups":[{"description":"Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.","id":"FG000","title":"Vd (Bortezomib + Dexamethasone)"},{"description":"Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.","id":"FG001","title":"Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"15"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Complete response"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Stable disease"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Non compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Reason not specified"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Data not available"}],"milestones":[{"achievements":[{"comment":"Number of randomized and treated participants","groupId":"FG000","numSubjects":"46"},{"comment":"Number of randomized and treated participants","groupId":"FG001","numSubjects":"47"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"47"}],"type":"Intent-to-treat Participants"},{"achievements":[{"comment":"Participants who completed 8 cycles of treatment","groupId":"FG000","numSubjects":"14"},{"comment":"Participants who completed 8 cycles of treatment","groupId":"FG001","numSubjects":"15"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"32"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"24"}],"type":"Progression/Relapse"}],"milestones":[{"achievements":[{"comment":"Number of participants who entered follow-up phase","groupId":"FG000","numSubjects":"26"},{"comment":"Number of participants who entered follow-up phase","groupId":"FG001","numSubjects":"31"}],"type":"STARTED"},{"achievements":[{"comment":"Number of participants who completed follow-up phase","groupId":"FG000","numSubjects":"2"},{"comment":"Number of participants who completed follow-up phase","groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"31"}],"type":"NOT COMPLETED"}],"title":"Long Term Follow-up"}],"preAssignmentDetails":"A total of 93 participants were randomly allocated and they received at least 1 dose of study drug and were included in the safety analysis. Of these follow-up data on treatment response was not available for 3 participants, so, they were excluded from the Intent-to-treat (ITT) analysis data set and so, ITT included 90 participants.","recruitmentDetails":"The study was conducted between 23 December 2008 and 10 January 2013 and recruited patients from 42 study centers in Germany."}