Only 49 spots left

~49 spots leftby Apr 2026

CC-220 Combination Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+177 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Celgene

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, CC-220, alone and with other drugs for patients with multiple myeloma who haven't responded to other treatments or are newly diagnosed. The drugs work by controlling cancer cell growth and killing cancer cells through different mechanisms.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with Multiple Myeloma, either newly diagnosed and untreated (NDMM) or those whose disease has returned after treatment (RRMM). They must be in fairly good health overall, as indicated by an ECOG score of 0-2. People who have had other cancers within the last 5 years or have a significant medical condition that could interfere with the study cannot participate.

Inclusion Criteria

I have been diagnosed with multiple myeloma and have not received any treatment.

I am not planned for or eligible for stem cell transplant as my initial treatment.

My multiple myeloma has worsened within 2 months after my last treatment.

See 1 more

Exclusion Criteria

My multiple myeloma does not produce detectable levels of M protein.

I do not have any health issues that would stop me from joining the study.

I have been cancer-free for over 5 years, except for multiple myeloma or certain non-invasive cancers.

Treatment Details

Interventions

Bortezomib (Proteasome Inhibitor)
Carfilzomib (Proteasome Inhibitor)
CC-220 (Immunomodulatory Agent)
Daratumumab (Monoclonal Antibodies)
Dexamethasone (Corticosteroid)

Trial OverviewThe trial is testing different doses and combinations of a drug called CC-220 alone or with other treatments like Dexamethasone, Daratumumab, Bortezomib, and Carfilzomib. It's divided into two parts: finding the right dose and then expanding to more patients at that dose to see how well it works for both new and returning cases of Multiple Myeloma.

Participant Groups

12Treatment groups

Experimental Treatment

Group I: Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2Experimental Treatment3 Interventions

Oral CC-220 at 1.0mg, 1.3mg or 1.6mg from Days 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. Subcutaneous DARA at 1800 mg over 3 to 5minutes on Days 1, 8, 15, and 22 at cycle 1-2 of a 28-day cycle, Days1, and 15 at cycle 3-6 of a 28-day cycle, and Day1 at cycle ≥7 of each 28-day cycle.

Group II: Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2Experimental Treatment3 Interventions

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.

Group III: Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2Experimental Treatment3 Interventions

Oral CC-220 at 1.0mg, 1.3mg or 1.6mg administered at cycles 1 to 8 on Days 1 to 14 of each 21-day cycle and cycles ≥ 9 on Days 1 to 21 of each 28-day cycle. 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.

Group IV: Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2Experimental Treatment2 Interventions

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.

Group V: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1Experimental Treatment3 Interventions

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 C1D2; 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, and 23 of each 28-day cycle. The DEX dose will be 20 mg.

Group VI: Cohort G1: CC-220 in combination with CFZ and DEX - Part 1Experimental Treatment3 Interventions

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, and 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

Group VII: Cohort F: CC-220 with DEX and bortezomib - Part 1Experimental Treatment3 Interventions

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, and 8 at cycle ≥9 of each 21-day cycle.

Group VIII: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1Experimental Treatment3 Interventions

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 a dose of Subcutaneous DARA at 1800 mg over 3 to 5minutes on Days 1, 8, 15,and 22 at cycle 1-2 of a 28-day cycle, Days1, and 15 at cycle 3-6 of a 28-day cycle, and Day1 at cycle ≥7 of each 28-day cycle.

Group IX: Cohort D: CC-220 in combination with Dexamethasone - Part 2Experimental Treatment2 Interventions

Oral CC-220 at Recommended Phase 2 dose (RP2D) 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

Group X: Cohort C: CC-220 Monotherapy in RRMM - Part 2Experimental Treatment1 Intervention

CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.

Group XI: Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1Experimental Treatment2 Interventions

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.

Group XII: Cohort A: CC-220 Monotherapy - Part 1Experimental Treatment1 Intervention

Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle