{"description":"All-cause mortality is reported for all participants enrolled/randomized in the study.\n\nSerious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":9,"description":"Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule).\n\nTreatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.","id":"EG000","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":4,"seriousNumAtRisk":9,"title":"Cohort 180 mg 5/14 Schedule (Phase 1b)"},{"deathsNumAffected":1,"deathsNumAtRisk":7,"description":"Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule).\n\nTreatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.","id":"EG001","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":2,"seriousNumAtRisk":7,"title":"Cohort 210 mg 5/14 Schedule (Phase 1b)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward.\n\nDexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Cohort 150/180 mg 5/14 Schedule (Phase 1b)"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.\n\nThis was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.","id":"EG003","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Cohort 210 mg 2/7 Schedule (Phase 1b)"},{"deathsNumAffected":1,"deathsNumAtRisk":4,"description":"Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.","id":"EG004","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"Cohort 240 mg 2/7 Schedule (Phase 1b)"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.","id":"EG005","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"title":"Cohort 270 mg 2/7 Schedule (Phase 1b)"},{"deathsNumAffected":0,"deathsNumAtRisk":8,"description":"Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.","id":"EG006","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":3,"seriousNumAtRisk":8,"title":"Cohort 300 mg 2/7 Schedule (Phase 1b)"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.","id":"EG007","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"title":"Cohort 330 mg 2/7 Schedule (Phase 1b)"},{"deathsNumAffected":0,"deathsNumAtRisk":18,"description":"The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14- day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.","id":"EG008","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":9,"seriousNumAtRisk":18,"title":"Phase 2 300 mg 2/7 Schedule"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9},{"groupId":"EG001","numAffected":2,"numAtRisk":7},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6},{"groupId":"EG006","numAffected":5,"numAtRisk":8},{"groupId":"EG007","numAffected":3,"numAtRisk":6},{"groupId":"EG008","numAffected":8,"numAtRisk":18}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6},{"groupId":"EG006","numAffected":0,"numAtRisk":8},{"groupId":"EG007","numAffected":1,"numAtRisk":6},{"groupId":"EG008","numAffected":0,"numAtRisk":18}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":1,"numAtRisk":6},{"groupId":"EG006","numAffected":0,"numAtRisk":8},{"groupId":"EG007","numAffected":1,"numAtRisk":6},{"groupId":"EG008","numAffected":0,"numAtRisk":18}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":1,"numAtRisk":6},{"groupId":"EG006","numAffected":0,"numAtRisk":8},{"groupId":"EG007","numAffected":1,"numAtRisk":6},{"groupId":"EG008","numAffected":0,"numAtRisk":18}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":2,"numAtRisk":7},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":4},{"groupId":"EG005","numAffected":2,"numAtRisk":6},{"groupId":"EG006","numAffected":3,"numAtRisk":8},{"groupId":"EG007","numAffected":2,"numAtRisk":6},{"groupId":"EG008","numAffected":4,"numAtRisk":18}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6},{"groupId":"EG006","numAffected":0,"numAtRisk":8},{"groupId":"EG007","numAffected":1,"numAtRisk":6},{"groupId":"EG008","numAffected":0,"numAtRisk":18}],"term":"Angina unstable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6},{"groupId":"EG006","numAffected":0,"numAtRisk":8},{"groupId":"EG007","numAffected":0,"numAtRisk":6},{"groupId":"EG008","numAffected":0,"numAtRisk":18}],"term":"Diastolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6},{"groupId":"EG006","numAffected":1,"numAtRisk":8},{"groupId":"EG007","numAffected":0,"numAtRisk":6},{"groupId":"EG008","numAffected":1,"numAtRisk":18}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6},{"groupId":"EG006","numAffected":0,"numAtRisk":8},{"groupId":"EG007","numAffected":0,"numAtRisk":6},{"groupId":"EG008","numAffected":0,"numAtRisk":18}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6},{"groupId":"EG006","numAffected":0,"numAtRisk":8},{"groupId":"EG007","numAffected":0,"numAtRisk":6},{"groupId":"EG008","numAffected":0,"numAtRisk":18}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":1,"numAtRisk":6},{"groupId":"EG006","numAffected":0,"numAtRisk":8},{"groupId":"EG007","numAffected":0,"numAtRisk":6},{"groupId":"EG008","numAffected":1,"numAtRisk":18}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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