NCT05372354 · Bristol-Myers Squibb
A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma
What this study is about
The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).
View original scientific description
The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).
Interventions
DRUG
CC-92480
Specified dose on specified days
DRUG
Tazemetostat
Specified dose on specified days
DRUG
BMS-986158
Specified dose on specified days
DRUG
Trametinib
Specified dose on specified days
DRUG
Dexamethasone
Specified dose on specified days
Primary outcome measures
Number of participants with adverse events (AEs)
Time frame: From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years
Number of participants with Serious AEs
Time frame: Up to approximately 4 years
Number of participants with AEs meeting protocol-defined DLT criteria
Time frame: Up to approximately 4 years
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 4 years
Number of deaths
Time frame: Up to approximately 4 years
Establish recommended Phase 2 dose (RP2D)
Time frame: Up to approximately 2 years
Establish dosing schedule of each combination for Part 2 Dose Expansion
Time frame: Up to approximately 2 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Relapsed or refractory multiple myeloma (MM) and must: 1. Have documented disease progression during or after their last myeloma therapy. 2. For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT.
- Must have measurable disease.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP).
Exclusion criteria
- Known active or history of central nervous system (CNS) involvement of MM
- Plasma cell leukemia; Waldenstrom's macroglobulin
Where
- Birmingham, Alabama
- Baltimore, Maryland
- Boston, Massachusetts
- Hackensack, New Jersey
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 5, 2025 · Source of record for eligibility and locations