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Looking for participantsPhase1/Phase2

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

Sponsor: Bristol-Myers Squibb

NCT ID: NCT05372354

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CC-92480 (drug), Tazemetostat (drug), BMS-986158 (drug), Trametinib (drug)
How long the study runs
Study runs about 48 months (dates as stated)
About the drug or intervention
CC-92480 — drug: Specified dose on specified days · Tazemetostat — drug: Specified dose on specified days · BMS-986158 — drug: Specified dose on specified days · Trametinib — drug: Specified dose on specified days · Dexamethasone — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at the safety, drug levels and effectiveness of a drug called CC-92480 (also known as BMS-986348) when taken with other treatments, in people whose multiple myeloma has come back (relapsed) or stopped responding to treatment (refractory). Multiple myeloma is a cancer of the blood. The study is run by Bristol-Myers Squibb.

Who can take part

  • Your multiple myeloma has come back or stopped responding to treatment, and got worse during or after your last myeloma treatment.
  • For Part 1 (finding the right dose): you cannot take, have not tolerated, or are not able to have established myeloma treatments that are known to help.
  • For Part 2 (expanding the dose group): your myeloma has come back or stopped responding after earlier treatment including an immunomodulatory drug, a proteasome inhibitor, an anti-CD38 antibody (a type of targeted treatment), and a T-cell redirecting therapy (for example CAR-T or bispecific treatment), unless you cannot have a T-cell redirecting therapy.
  • You have measurable disease (tests can detect your myeloma).
  • You are well enough to carry out daily activities (performance status score of 0 or 1 on a scale used by doctors).
  • You agree to follow the study's pregnancy prevention plan.

Who may not be able to

  • Myeloma in or around the brain or spinal cord (central nervous system), now or in the past.
  • Certain related conditions: plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or significant light-chain amyloidosis.
  • Heart problems or poor heart function that affects your health.
  • COVID-19 infection within 14 days before starting (if you had no or mild symptoms) or 28 days (if it was severe).
  • For Part 1: previous treatment with CC-92480. For Part 2: previous treatment with CC-92480, tazemetostat, BMS-986158, or trametinib.
  • A stem cell transplant from a donor at any time, or your own stem cell transplant within 12 weeks before starting study treatment.
  • Within 14 days before starting: plasmapheresis (plasma exchange), major surgery, radiotherapy (except local treatment for bone damage caused by myeloma), or any systemic myeloma drug treatment.
  • Any experimental (investigational) treatment within 28 days or 5 half-lives (whichever is shorter) before starting.
  • A COVID-19 vaccine within 14 days before starting the study.

What taking part involves

  • • Taking the study drug CC-92480 (BMS-986348) together with other treatments.
  • • Other details of the treatment schedule are not stated — ask the trial team.

Time commitment: Number of visits and how long the study lasts are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
260
Started
2022-10-18
Last checked
2025-08

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase1/Phase2 - 260 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with multiple myeloma

Where?

  • • Manchester - The Christie NHS Foundation Trust
  • • Leicester - Local Institution - 0001
  • • Liverpool - Local Institution - 0014
  • • Oxford - Churchill Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD38

Treatment history

Treatments you must have had:

  • ✓ measurable disease

What the study is looking for

  • ✓Relapsed or refractory multiple myeloma (MM) and must:
  • ✓Have documented disease progression during or after their last myeloma therapy.
  • ✓Must have cancer that can be measured on scans.
  • ✓activity scale Performance Status (ECOG PS) of 0 or 1.
  • ✓Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP).

Who cannot take part

  • ✗Known active or history of central nervous system (CNS) involvement of MM
  • ✗Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and...
  • ✗Impaired heart function or clinically significant heart disease
  • ✗Previous SARS-CoV-2 infection within 14 days for not causing symptoms or mild causing symptoms infections or 28 days for...
  • ✗For Part 1: received prior therapy with CC-92480
See the full criteria
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

Where Is This Study? (5 UK sites)

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Emma Searle, Site 00174401614463869

Local Institution - 0001

Leicester LE1 5WW, United Kingdom

WITHDRAWN

Local Institution - 0014

Liverpool L7 8YA, United Kingdom

WITHDRAWN

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Karthik Ramasamy, Site 0016+4401782674844

NIHR UCLH Clinical Research Facility

London W1T 7HA, United Kingdom

Recruiting
Site contact (verified)
Rakesh Popat, Site 0006111-111-1111

How to Get in Touch

BMS Study Connect Contact Center www.BMSStudyConnect.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2025-08