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Proteasome Inhibitor

CC-92480 + Standard Treatments for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
For participants in Cohorts A, B, C, D, E, F, H, I, J, and K: documented diagnosis of multiple myeloma (MM) and measurable disease, documented disease progression during or after their last antimyeloma regimen, achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Must not have
Known central nervous system (CNS) involvement with myeloma
Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclon), or clinically significant amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, nerve damage causing pain or numbness, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I have multiple myeloma with measurable disease and it has worsened after treatment but I responded to at least one prior treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My myeloma has spread to my brain or spinal cord.
Select...
I have a specific blood disorder such as plasma cell leukemia or Waldenstrom's macroglobulinemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-92480
2018
Completed Phase 1
~150
Isatuximab
2016
Completed Phase 3
~370
Bortezomib
2005
Completed Phase 3
~1410
Dexamethasone
2007
Completed Phase 4
~2650
Daratumumab
2014
Completed Phase 3
~2000
Carfilzomib
2017
Completed Phase 3
~1430
Elotuzumab
2016
Completed Phase 3
~870

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Myeloma treatments often target specific cellular mechanisms to inhibit cancer cell growth and survival. Proteasome inhibitors (e.g., bortezomib) block the proteasome's function, leading to the accumulation of toxic proteins in cancer cells. Immunomodulatory drugs (IMiDs) like lenalidomide and pomalidomide, and newer CELMoDs like CC-92480, bind to cereblon, altering the activity of the E3 ubiquitin ligase complex, which results in the degradation of proteins essential for myeloma cell survival. Monoclonal antibodies (e.g., daratumumab) target specific antigens on myeloma cells, marking them for destruction by the immune system. These mechanisms are crucial as they provide multiple avenues to disrupt the cancer cells' lifecycle, offering hope for improved outcomes and prolonged survival for Multiple Myeloma patients.

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
130,016 Total Patients Enrolled
145 Trials studying Multiple Myeloma
41,379 Patients Enrolled for Multiple Myeloma
Alessandro Ghiddi, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,563 Previous Clinical Trials
3,383,744 Total Patients Enrolled
76 Trials studying Multiple Myeloma
28,680 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03989414 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Subcohort B3: CC-92480 with daratumumab and dexamethasone, Subcohort E1: CC-92480 with daratumumab and dexamethasone, Cohort D: CC-92480 with bortezomib and dexamethasone, Subcohort B2: CC-92480 with daratumumab and dexamethasone, Cohort K: CC-92480 with isatuximab and dexamethasone, Subcohort E3: CC-92480 with daratumumab and dexamethasone, Subcohort B1: CC-92480 with daratumumab and dexamethasone, Subcohort E2: CC-92480 with daratumumab and dexamethasone, Cohort G: CC-92480 with bortezomib and dexamethasone, Cohort F: CC-92480 with carfilzomib and dexamethasone, Cohort J: CC-92480 with elotuzumab and dexamethasone, Cohort A: CC-92480 with bortezomib and dexamethasone, Cohort C: CC-92480 with carfilzomib and dexamethasone, Cohort H: CC-92480 with elotuzumab and dexamethasone, Cohort I: CC-92480 with isatuximab and dexamethasone
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT03989414 — Phase 1 & 2
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03989414 — Phase 1 & 2
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