{"groups":[{"description":"Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"FG000","title":"Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"FG001","title":"Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.","id":"FG002","title":"Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"FG003","title":"Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"FG004","title":"Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first.\n\nAfter completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment.","id":"FG005","title":"Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}],"type":"Study Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"3"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"In the Phase 1b portion of the study participants were enrolled sequentially using a standard 3 + 3 dose escalation schema.\n\nThe final planned analysis for efficacy was performed using a data cut-off date of 18 July 2016, at which time 3 participants remained on treatment. The final analysis of safety was conducted after all participants had discontinued treatment (23 September 2019).","recruitmentDetails":"This study was conducted at 17 study centers in the United States. Twenty-two participants were enrolled, however one participant discontinued before being assigned to a treatment cohort.\n\nEnrollment was halted during dose-escalation and Phase 2 was not conducted."}