CC-92480 + Standard Treatments for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+95 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 is testing a new drug called CC-92480 to see if it can help patients who are already getting standard treatments. The goal is to find out if adding this new drug can make their treatment work better.

Eligibility Criteria

This trial is for adults with Multiple Myeloma who've seen their cancer grow despite treatment and responded at least once to prior therapy. They should be fairly active and able to care for themselves (ECOG score of 0-2). People can't join if they have myeloma in the brain, took strong immune drugs recently, or have certain other blood disorders or uncontrolled conditions like high blood pressure.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I have multiple myeloma with measurable disease and it has worsened after treatment but I responded to at least one prior treatment.

Exclusion Criteria

I have not taken immunosuppressive medication in the last 14 days.

Other protocol-defined inclusion/exclusion criteria apply

My myeloma has spread to my brain or spinal cord.

+2 more

Participant Groups

The study tests CC-92480 combined with standard myeloma treatments (like Isatuximab, Bortezomib) to see how safe it is and if it works against cancer that's come back or didn't respond well before. Participants will receive different combinations based on which group they're assigned to.

15Treatment groups

Experimental Treatment

Group I: Subcohort E3: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

Group II: Subcohort E2: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight, administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards

Group III: Subcohort E1: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 28-day cycle Either IV DARA administered at a dose of 16 mg/kg or SC DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

Group IV: Subcohort B3: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort B dose administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

Group V: Subcohort B2: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort dose administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight, administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards

Group VI: Subcohort B1: CC-92480 with daratumumab and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort dose administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

Group VII: Cohort K: CC-92480 with isatuximab and dexamethasoneExperimental Treatment3 Interventions

Group VIII: Cohort J: CC-92480 with elotuzumab and dexamethasoneExperimental Treatment3 Interventions

Group IX: Cohort I: CC-92480 with isatuximab and dexamethasoneExperimental Treatment3 Interventions

Group X: Cohort H: CC-92480 with elotuzumab and dexamethasoneExperimental Treatment3 Interventions

Group XI: Cohort G: CC-92480 with bortezomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 21-day cycle Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle up to Cycle 6 Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle up to Cycle 6

Group XII: Cohort F: CC-92480 with carfilzomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 28-day cycle Intravenous (IV) carfilzomib 20 mg/m2 then 56 mg/m2 administered over a 28-day cycle Oral/IV dexamethasone 40 mg/day (20 mg/day for subjects > 75 years old) administered over a 28-day cycle

Group XIII: Cohort D: CC-92480 with bortezomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at RP2D administered over a 21-day cycle Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle in the first 8 cycles and on days 1, 2, 8 and 9 after Cycle 8

Group XIV: Cohort C: CC-92480 with carfilzomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort C dose administered over a 28-day cycle Intravenous (IV) carfilzomib 20 mg/m2 then 56 mg/m2 administered over a 28-day cycle Oral/IV dexamethasone 40 mg/day (20 mg/day for subjects > 75 years old) administered over a 28-day cycle

Group XV: Cohort A: CC-92480 with bortezomib and dexamethasoneExperimental Treatment3 Interventions

Oral CC-92480 at specified cohort A dose administered over a 21-day cycle Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle in the first 8 cycles and on days 1, 2, 8 and 9 after Cycle 8

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: