Multiple MyelomaPhase 1/2NCT06988488
A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1/2 study testing Elranatamab, Mezigdomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 22 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and 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?
- Elranatamab, Mezigdomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 7 Oct 2025to 3 Jun 2027
- 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
- Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2).
- Measurable MM by local laboratory.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
- Adherence to contraception requirements.
Who cannot join
- Prior treatment with mezigdomide.
- Prior treatment with T cell engaging or T cell engager (TCE).
- Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy> 6 months from the start of study therapy
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
22 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
22 sites in 8 countries
United States4 sites, 4 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Luciano Costa, Site 0001, 205-934-9695
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
David Siegel, Site 0028, 551-996-8704
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jing Christine Ye, Site 0005, 734-232-0744
- Recruiting
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, 06510
Noffar Bar, Site 0029, 000-000-0000
Canada4 sites, 4 recruiting
- Recruiting
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Nizar Bahlis, Site 0032, 4032202801
- Recruiting
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, B3H 2Y9
Darrell White, Site 0027, 9024734642
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Guido Lancman, Site 0024, 4169462059
- Not yet recruiting
Local Institution - 0026
Vancouver, British Columbia, V5Z 4E6
Site 0026
Germany3 sites, 3 recruiting
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Raphael Teipel, Site 0015, 493514582583
- Recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Katja Weisel, Site 0013, 4940741058787
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Marc-Steffen Raab, Site 0014, 496221565427
United Kingdom3 sites, 3 recruiting
- Recruiting
University College London Hospital
London, England, W1T 7HA
Selina Chavda, Site 0016, 02034472929
- Recruiting
Royal Marsden Hospital (Sutton)
London, Sutton, SM2 5PT
Charlotte Pawlyn, Site 0018, 02087224000
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Emma Searle, Site 0020, +447917554940
China2 sites, 2 recruiting
- Recruiting
Tongji University - Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200434
Weijun Fu, Site 0031, +8613816052522
- Not yet recruiting
Local Institution - 0030
Suzhou, Jiangsu, 215006
Site 0030
Greece2 sites, 2 recruiting
- Recruiting
Evangelismos General Hospital of Athens
Athens, Attikí, 106 76
Sosana Delimpasi, Site 0011, 6944822722
- Recruiting
Alexandra General Hospital of Athens
Athens, Attikí, 115 28
MELETIOS DIMOPOULOS, Site 0012, +306932418798
Norway2 sites, 2 recruiting
- Recruiting
Sykehusapoteket Ull
Oslo, 0450
Fredrik Hellem Schjesvold, Site 0019, +4799697796
- Recruiting
St. Olavs Hospital
Trondheim, Sør-Trøndelag, 7030
Tobias Slordahl, Site 0017, 004791145009
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Maria Victoria Mateos Manteca, Site 0022, 34923291100
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Enrique Ocio, Site 0021, +34649391848
About this study
Official title: A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).
- Conditions
- Multiple Myeloma
- Being tested
- Elranatamab, Mezigdomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElranatamabDrug
Also called Elrexfio, PF-0686313
Specified dose on specified days
MezigdomideDrug
Also called BMS-986348, CC-92480
Specified dose on specified days
DexamethasoneDrug
Also called Decadron®
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Not described Receives: Drug: Elranatamab; Drug: Mezigdomide; Drug: Dexamethasone |
| Phase 2 | Experimental | Not described Receives: Drug: Elranatamab; Drug: Mezigdomide; 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 mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with Serious AEs
Measured: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with AEs meeting protocol-defined DLT criteria
Measured: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with AEs leading to discontinuation
Measured: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of deaths
Measured: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Recommended Phase 2 Dose (RP2D)
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
Secondary outcomes (8)
International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Complete Response Rate (CRR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Time to Response (TTR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Duration of Response (DOR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Progression-free Survival (PFS)
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Overall Survival (OS)
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
Number of participants who achieve minimal residual disease (MRD) negativity
Defined as less than 1 in 10^5 nucleated cells in BMA for participants who achieve CR or better at any time after enrollment
Measured: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start7 Oct 2025
- Primary completion31 May 2027 (estimated)
- Study completion3 Jun 2027 (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 CelgeneThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- 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
- NCT06988488
- Sponsor's protocol ID
- CA057-1040
- Other IDs
- 2025-522090-11, U1111-1317-4901, 2025
- Status last verified
- Sep 2026
- First submitted
- 16 May 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06988488
- Acronym / sponsor ID
- CA057-1040
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 25 May 2025 (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 evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: Elranatamab, Drug: Mezigdomide, Drug: Dexamethasone |
| Phase 2 | Experimental | Drug: Elranatamab, Drug: Mezigdomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2).
- Measurable MM by local laboratory.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
- Adherence to contraception requirements.
Key exclusion criteria (4 listed)
- Prior treatment with mezigdomide.
- Prior treatment with T cell engaging or T cell engager (TCE).
- Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy> 6 months from the start of study therapy
- Other protocol-defined Inclusion/Exclusion criteria apply.
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 |
|---|---|---|
| ElranatamabAlso: Elrexfio, PF-0686313Specified dose on specified days | Drug | Phase 1, Phase 2 |
| MezigdomideAlso: BMS-986348, CC-92480Specified dose on specified days | Drug | Phase 1, Phase 2 |
| DexamethasoneAlso: Decadron®Specified dose on specified days | Drug | Phase 1, Phase 2 |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with Serious AEs
Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with AEs meeting protocol-defined DLT criteria
Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with AEs leading to discontinuation
Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of deaths
Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Recommended Phase 2 Dose (RP2D)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
8 secondary outcomes
International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Complete Response Rate (CRR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Time to Response (TTR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Duration of Response (DOR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Progression-free Survival (PFS)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Overall Survival (OS)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
Number of participants who achieve minimal residual disease (MRD) negativity
Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
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 2 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Elranatamab, Mezigdomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 22 sites in 8 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 4 inclusion and 4 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, Germany, United Kingdom, China and 3 more countries. 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 Clinical Trials Contact Center www.BMSClinicalTrials.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 mezigdomide dose or 90 days after last elranatamab dose, whichever is longer). The study lists 6 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 2 Sep 2026.