{"groups":[{"description":"In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.","id":"FG000","title":"Oprozomib IR 150 mg/Day + Dexamethsone"},{"description":"In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.","id":"FG001","title":"Oprozomib GR 150 mg/Day + Dexamethasone"},{"description":"In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"FG002","title":"Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"FG003","title":"Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"FG004","title":"Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"FG005","title":"Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"FG006","title":"Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"FG007","title":"Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone"},{"description":"Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \\[NCT01416428\\], 2012-001 \\[NCT01832727\\], OPZ003 \\[NCT01881789\\], OPZ007 \\[NCT01999335\\], and OPZ009 \\[NCT02244112\\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.","id":"FG008","title":"Open-label Roll-over"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"4"}],"type":"Sponsor decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"Not treated due to adverse event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"11"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"7"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"},{"comment":"1 participant enrolled in arm Oprozomib IR 200 mg/day + pomalidomide + dexamethasone received oprozomib IR 150 mg + pomalidomide + dexamethasone.","groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"10"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"7"}],"type":"Received Oprozomib"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"7"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"5"},{"groupId":"FG008","numSubjects":"1"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"7"},{"groupId":"FG007","numSubjects":"3"},{"groupId":"FG008","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Part 1 evaluated oprozomib formulations (immediate-release \\[IR\\] and gastro-retentive \\[GR\\]) administered at a 150 mg/day dose level with dexamethasone. Part 2 evaluated the IR and GR oprozomib formulations administered at different increasing dose levels with pomalidomide and dexamethasone. An open-label roll-over part was conducted in the United States to include eligible participants from separate Amgen oprozomib studies in a single arm as pre-specified in the statistical analysis plan (SAP).","recruitmentDetails":"Participants were enrolled at 26 research centers in Australia, Canada, Spain, and the United States, and participated from 17 January 2017 to 06 October 2022."}