Name | Type | Description | Interventions |
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Cohort A: CC-220 Monotherapy - Part 1 | Experimental | Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle | |
Cohort B: CC-220 in combination with Dexamethasone - Part 1 | Experimental | Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8,15, and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the investigator's best judgment. | |
Cohort D: CC-220 in combination with Dexamethasone - Part 2 | Experimental | Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle
Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. | |
Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1 | Experimental | Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Intravenous DARA at dose 16mg/kg on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.
Once the MTD and/or RP2D is determined in Cohort E (CC-220Dd), subjects will be enrolled at this dose level using SC DARA.
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Subcutaneous DARA at dose 1800 mg over 3 to 5 minutes on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle. | - CC-220
- Dexamethasone
- Daratumumab - 16mg/kg
- Daratumumab- 1800mg
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Cohort F: CC-220 with DEX and bortezomib - Part 1 | Experimental | Oral CC-220 at dose specified by cohort dose level from Day 1-14 of each 21-day cycle.
Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, and 15 of each 21-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, and 15 of each 21-day cycle.
Subcutaneous BTZ at dose 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle. | - CC-220
- Dexamethasone
- Bortezomib (BTZ)
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Cohort G1-CC-220 in combination with CFZ and DEX -Part 1 | Experimental | Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Intravenous (IV) CFZ (Carfilzomib)administered at a starting dose of 20 mg/m2 on C1D1; and at a dose specified by cohort dose level thereafter on days 1, 8, 15 of each 28-day cycle
Oral DEX (Dexamethasone) on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects ≤ 75 years old, the DEX dose will be 40 mg. For subjects > 75 years old, the DEX dose will be 20 mg | - CC-220
- Dexamethasone
- Carfilzomib
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Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1 | Experimental | Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle
Oral DEX on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 28-day cycle. The DEX dose will be 20 mg | - CC-220
- Dexamethasone
- Carfilzomib
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CohortI-CC-220 in combination with DEX in post BCMA RRMM-Part2 | Experimental | Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle
Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. | |
CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2 | Experimental | Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle (Cycle 1 to 8) and from Day 1-21 of each 28-day cycle (Cycle 9 and above).
Oral DEX at Cycles 1 to 8, 20 mg (≤ 75 years old) or 10 mg (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle and Cycles ≥ 9, 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-8 of each 21-day cycle. | - CC-220
- Dexamethasone
- Bortezomib (BTZ)
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CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2 | Experimental | Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle.
Oral DEX at 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) for Cycles 1 to 6 on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-6 of each 21-day cycle. | - CC-220
- Dexamethasone
- Bortezomib (BTZ)
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