Multiple MyelomaPhase 1/2NCT05372354
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
A Phase 1/2 study testing CC-92480, Tazemetostat and BMS-986158 in people with Multiple Myeloma, run by Bristol-Myers Squibb at 17 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CC-92480, Tazemetostat and BMS-986158
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 18 Oct 2022to 12 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory multiple myeloma (MM) and must:
- Have documented disease progression during or after their last myeloma therapy.
- 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).
Who cannot join
- 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
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- 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:
- Plasmapheresis
- Major surgery
- Radiation therapy other than local therapy for myeloma associated bone lesions
- 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
Trial locations and contacts
17 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
First line of email MUST contain NCT # and Site #. contact
17 sites in 5 countries
United States5 sites, 5 recruiting
- Recruiting
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Syed Abbas Ali, Site 0015, 443-287-7104
- Recruiting
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35249
Luciano Costa, Site 0002, 205-934-9695
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Monique Hartley-Brown, Site 0010, 857-299-5736
- Recruiting
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
David Siegel, Site 0013, 551-996-8704
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Saad Usmani, Site 0007
United Kingdom5 sites, 3 recruiting
- Withdrawn
Local Institution - 0001
Leicester, Leicestershire, LE1 5WW
- Withdrawn
Local Institution - 0014
Liverpool, Merseyside, L7 8YA
- Recruiting
NIHR UCLH Clinical Research Facility
London, W1T 7HA
Rakesh Popat, Site 0006, 111-111-1111
- Recruiting
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
Emma Searle, Site 0017, 4401614463869
- Recruiting
Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
Karthik Ramasamy, Site 0016, +4401782674844
Canada3 sites, 3 recruiting
- Recruiting
Alberta Health Services AHS - Foothills Medical Centre FMC
Calgary, Alberta, T2N 5G2
Nizar Bahlis, Site 0009, 4039441880
- Recruiting
University of Alberta - Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Michael Chu, Site 0008, 7804328757
- Recruiting
University Health Network UHN - Princess Margaret Hospital PMH
Toronto, Ontario, M5G 2M9
Donna Reece, Site 0004, 4169462824
Spain3 sites, 3 recruiting
- Recruiting
ICO - Hospital Germans Trias i Pujol
Barcelona, 08026
Albert Oriol Rocafiguera, Site 0011, 34934978987
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Joaquin Martinez Lopez, Site 0005, 34913908525
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39008
Enrique Ocio, Site 0003, +34649391848
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Outside US and Canada, 0450
Fredrik Hellem Schjesvold, Site 0012, +4799697796
About this study
Official title: 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).
- Conditions
- Multiple Myeloma
- Being tested
- CC-92480, Tazemetostat, BMS-986158, Trametinib, Dexamethasone
- Keywords
- BMS-986348, CC-92480, BMS-986158, Dexamethasone, Tazemetostat, Trametinib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-92480Drug
Also called BMS-986348
Specified dose on specified days
TazemetostatDrug
Specified dose on specified days
BMS-986158Drug
Specified dose on specified days
TrametinibDrug
Specified dose on specified days
DexamethasoneDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Arm A: Dose Finding | Experimental | Not described Receives: Drug: CC-92480; Drug: Tazemetostat; Drug: Dexamethasone |
| Part 1 Arm B: Dose Finding | Experimental | Not described Receives: Drug: CC-92480; Drug: BMS-986158; Drug: Dexamethasone |
| Part 1 Arm C: Dose Finding | Experimental | Not described Receives: Drug: CC-92480; Drug: Trametinib; Drug: Dexamethasone |
| Part 2 Arm D: Dose Expansion | Active comparator | Not described Receives: Drug: CC-92480; Drug: Dexamethasone |
| Part 2 Arm E: Dose Expansion | Experimental | Not described Receives: Drug: CC-92480; Drug: Tazemetostat; Drug: Dexamethasone |
| Part 2 Arm G: Dose Expansion | Experimental | Not described Receives: Drug: CC-92480; Drug: Trametinib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: 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
Measured: Up to approximately 4 years
Number of participants with AEs meeting protocol-defined DLT criteria
Measured: Up to approximately 4 years
Number of participants with AEs leading to discontinuation
Measured: Up to approximately 4 years
Number of deaths
Measured: Up to approximately 4 years
Establish recommended Phase 2 dose (RP2D)
Measured: Up to approximately 2 years
Establish dosing schedule of each combination for Part 2 Dose Expansion
Measured: Up to approximately 2 years
Secondary outcomes (12)
Overall response rate (ORR)
Measured: Up to approximately 4 years
Very good partial response rate (VGPRR)
Measured: Up to approximately 4 years
Complete response rate (CRR)
Measured: Up to approximately 4 years
Time-to-response (TTR)
Measured: Up to approximately 4 years
Duration of response (DOR)
Measured: Up to approximately 4 years
Progression-free survival (PFS)
Measured: Up to approximately 4 years
Maximum observed plasma concentration (Cmax)
Measured: Up to approximately 28 days
Time to maximum plasma concentration (Tmax)
Measured: Up to approximately 28 days
Area under the concentration-time curve (AUC)
Measured: Up to approximately 28 days
Terminal Half-Life (T-Half)
Measured: Up to approximately 28 days
Apparent total body clearance (CLT/F)
Measured: Up to approximately 28 days
Apparent volume of distribution (Vz/F)
Measured: Up to approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start18 Oct 2022
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372354
- Sponsor's protocol ID
- CA057-003
- Other IDs
- 2023-509384-25, U1111-1269-5704, 2023
- Status last verified
- Aug 2025
- First submitted
- 6 May 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05372354
- Acronym / sponsor ID
- CA057-003
- Conditions
- Multiple Myeloma
- Keywords
- BMS-986348, CC-92480, BMS-986158, Dexamethasone, Tazemetostat, Trametinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 Arm A: Dose Finding | Experimental | Drug: CC-92480, Drug: Tazemetostat, Drug: Dexamethasone |
| Part 1 Arm B: Dose Finding | Experimental | Drug: CC-92480, Drug: BMS-986158, Drug: Dexamethasone |
| Part 1 Arm C: Dose Finding | Experimental | Drug: CC-92480, Drug: Trametinib, Drug: Dexamethasone |
| Part 2 Arm D: Dose Expansion | Active comparator | Drug: CC-92480, Drug: Dexamethasone |
| Part 2 Arm E: Dose Expansion | Experimental | Drug: CC-92480, Drug: Tazemetostat, Drug: Dexamethasone |
| Part 2 Arm G: Dose Expansion | Experimental | Drug: CC-92480, Drug: Trametinib, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Relapsed or refractory multiple myeloma (MM) and must:
- 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).
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-92480Also: BMS-986348Specified dose on specified days | Drug | Part 1 Arm A: Dose Finding, Part 1 Arm B: Dose Finding, Part 1 Arm C: Dose Finding, Part 2 Arm D: Dose Expansion, Part 2 Arm E: Dose Expansion, Part 2 Arm G: Dose Expansion |
| TazemetostatSpecified dose on specified days | Drug | Part 1 Arm A: Dose Finding, Part 2 Arm E: Dose Expansion |
| BMS-986158Specified dose on specified days | Drug | Part 1 Arm B: Dose Finding |
| TrametinibSpecified dose on specified days | Drug | Part 1 Arm C: Dose Finding, Part 2 Arm G: Dose Expansion |
| DexamethasoneSpecified dose on specified days | Drug | Part 1 Arm A: Dose Finding, Part 1 Arm B: Dose Finding, Part 1 Arm C: Dose Finding, Part 2 Arm D: Dose Expansion, Part 2 Arm E: Dose Expansion, Part 2 Arm G: Dose Expansion |
Primary outcome
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
12 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 4 years
Very good partial response rate (VGPRR)
Time frame: Up to approximately 4 years
Complete response rate (CRR)
Time frame: Up to approximately 4 years
Time-to-response (TTR)
Time frame: Up to approximately 4 years
Duration of response (DOR)
Time frame: Up to approximately 4 years
Progression-free survival (PFS)
Time frame: Up to approximately 4 years
Maximum observed plasma concentration (Cmax)
Time frame: Up to approximately 28 days
Time to maximum plasma concentration (Tmax)
Time frame: Up to approximately 28 days
Area under the concentration-time curve (AUC)
Time frame: Up to approximately 28 days
Terminal Half-Life (T-Half)
Time frame: Up to approximately 28 days
Apparent total body clearance (CLT/F)
Time frame: Up to approximately 28 days
Apparent volume of distribution (Vz/F)
Time frame: Up to approximately 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
First line of email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CC-92480, Tazemetostat and BMS-986158 in people with Multiple Myeloma, run by Bristol-Myers Squibb at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, United Kingdom, Canada, Spain, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.