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
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