{"groups":[{"description":"Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.","id":"FG000","title":"Part 1: VMP + Siltuximab"},{"description":"Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.","id":"FG001","title":"Part 2: VMP"},{"description":"Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.","id":"FG002","title":"Part 2: VMP + Siltuximab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"7"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"5"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Did not receive study treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"54"},{"groupId":"FG002","numSubjects":"52"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"53"},{"groupId":"FG002","numSubjects":"52"}],"type":"Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"27"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"25"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"9"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"9"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"comment":"Participants who received siltuximab only during the 18-month maintenance period","groupId":"FG002","numSubjects":"21"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"21"}],"type":"NOT COMPLETED"}],"title":"Maintainance Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"10"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"27"}],"type":"Study terminated by sponsor"}],"milestones":[{"achievements":[{"comment":"Participants followed until death or 3.5 years after the last participant was assigned to treatment","groupId":"FG000","numSubjects":"12"},{"comment":"Participants followed until death or 3.5 years after the last participant was assigned to treatment","groupId":"FG001","numSubjects":"53"},{"comment":"Participants followed until death or 3.5 years after the last participant was assigned to treatment","groupId":"FG002","numSubjects":"52"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"11"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"46"},{"groupId":"FG002","numSubjects":"41"}],"type":"NOT COMPLETED"}],"title":"Follow-up Period"}],"preAssignmentDetails":"In Part 2, 105 participants received treatment (VMP: 53 and VMP+Siltuximab: 52). In the VMP+Siltuximab arm, 21 participants who achieved partial response or better entered the maintenance period and received only Siltuximab for 18 months, or until disease progression, unacceptable toxicity, or withdrawal from treatment, whichever occurred first.","recruitmentDetails":"The study was conducted at 40 centers in 12 countries: Australia; France; India; Israel; Italy; Poland; Romania; Russian Federation; Singapore; South Korea; Spain; and the United States."}