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

August 29, 2025 updated by: Bristol-Myers Squibb

An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of email MUST contain NCT # and Site #.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Alberta Health Services AHS - Foothills Medical Centre FMC
        • Contact:
          • Nizar Bahlis, Site 0009
          • Phone Number: 4039441880
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • University of Alberta - Cross Cancer Institute
        • Contact:
          • Michael Chu, Site 0008
          • Phone Number: 7804328757
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network UHN - Princess Margaret Hospital PMH
        • Contact:
          • Donna Reece, Site 0004
          • Phone Number: 4169462824
  • Norway
    • Outside US and Canada
      • Oslo, Outside US and Canada, Norway, 0450
        • Recruiting
        • Oslo University Hospital
        • Contact:
          • Fredrik Hellem Schjesvold, Site 0012
          • Phone Number: +4799697796
  • Spain
      • Barcelona, Spain, 08026
        • Recruiting
        • ICO - Hospital Germans Trias I Pujol
        • Contact:
          • Albert Oriol Rocafiguera, Site 0011
          • Phone Number: 34934978987
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Joaquin Martinez Lopez, Site 0005
          • Phone Number: 34913908525
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
          • Enrique Ocio, Site 0003
          • Phone Number: +34649391848
  • United Kingdom
      • London, United Kingdom, W1T 7HA
        • Recruiting
        • NIHR UCLH Clinical Research Facility
        • Contact:
          • Rakesh Popat, Site 0006
          • Phone Number: 111-111-1111
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
          • Emma Searle, Site 0017
          • Phone Number: 4401614463869
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Withdrawn
        • Local Institution - 0001
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8YA
        • Withdrawn
        • Local Institution - 0014
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Recruiting
        • Churchill Hospital
        • Contact:
          • Karthik Ramasamy, Site 0016
          • Phone Number: +4401782674844
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • UAB Comprehensive Cancer Center
        • Contact:
          • Luciano Costa, Site 0002
          • Phone Number: 205-934-9695
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
        • Contact:
          • Syed Abbas Ali, Site 0015
          • Phone Number: 443-287-7104
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Monique Hartley-Brown, Site 0010
          • Phone Number: 857-299-5736
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack UMC
        • Contact:
          • David Siegel, Site 0013
          • Phone Number: 551-996-8704
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Saad Usmani, Site 0007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
  • Impaired cardiac function or clinically significant cardiac disease
  • Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
  • For Part 1: received prior therapy with CC-92480
  • For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
  • Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment

  • Received any of the following within 14 days prior to initiating study treatment:

    1. Plasmapheresis
    2. Major surgery
    3. Radiation therapy other than local therapy for myeloma associated bone lesions
    4. Use of any systemic anti-myeloma drug therapy
  • Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
  • COVID-19 vaccine within 14 days prior to C1D1

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Arm A: Dose Finding
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
Drug: Dexamethasone
Specified dose on specified days
Drug: Tazemetostat
Specified dose on specified days
Experimental: Part 1 Arm B: Dose Finding
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
Drug: Dexamethasone
Specified dose on specified days
Drug: BMS-986158
Specified dose on specified days
Experimental: Part 1 Arm C: Dose Finding
Drug: Trametinib
Specified dose on specified days
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
Drug: Dexamethasone
Specified dose on specified days
Active Comparator: Part 2 Arm D: Dose Expansion
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
Drug: Dexamethasone
Specified dose on specified days
Experimental: Part 2 Arm E: Dose Expansion
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
Drug: Dexamethasone
Specified dose on specified days
Drug: Tazemetostat
Specified dose on specified days
Experimental: Part 2 Arm G: Dose Expansion
Drug: Trametinib
Specified dose on specified days
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
Drug: Dexamethasone
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years
Establish recommended Phase 2 dose (RP2D)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Establish dosing schedule of each combination for Part 2 Dose Expansion
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of deaths
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of participants with Serious AEs
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of participants with AEs meeting protocol-defined DLT criteria
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of response (DOR)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Progression-free survival (PFS)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Overall response rate (ORR)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Very good partial response rate (VGPRR)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Complete response rate (CRR)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Time-to-response (TTR)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Maximum observed plasma concentration (Cmax)
Time Frame: Up to approximately 28 days
Up to approximately 28 days
Time to maximum plasma concentration (Tmax)
Time Frame: Up to approximately 28 days
Up to approximately 28 days
Area under the concentration-time curve (AUC)
Time Frame: Up to approximately 28 days
Up to approximately 28 days
Terminal Half-Life (T-Half)
Time Frame: Up to approximately 28 days
Up to approximately 28 days
Apparent total body clearance (CLT/F)
Time Frame: Up to approximately 28 days
Up to approximately 28 days
Apparent volume of distribution (Vz/F)
Time Frame: Up to approximately 28 days
Up to approximately 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA057-003
  • U1111-1269-5704 (Registry Identifier: WHO)
  • 2023-509384-25 (Other Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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