ClinicalTrials.gg
RecruitingNCT06988488Updated Sep 2, 2026

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 interventional study of Elranatamab and Mezigdomide in Multiple Myeloma, sponsored by Celgene. Recruiting at 22 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Multiple Myeloma

Browse trials for

03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 62 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.

First submitted after Celgene became part of Bristol-Myers Squibb.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 with history of 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.
  • performance status (ECOG PS) of 0 to 1.
  • Adherence to requirements.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Phase 1

    Drug: Elranatamab · Drug: Mezigdomide · Drug: Dexamethasone

  • Experimental
    Phase 2

    Drug: Elranatamab · Drug: Mezigdomide · Drug: Dexamethasone

Interventions

  • Specified dose on specified days

    Also known as: Elrexfio, PF-0686313

  • Specified dose on specified days

    Also known as: BMS-986348, CC-92480

  • Specified dose on specified days

    Also known as: Decadron®

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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

    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)

07

Study locations

20 of 22 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    Recruiting
    • Luciano Costa, Site 0001 · Contact205-934-9695
  • Yale New Haven Hospital-Smilow Cancer Center
    New Haven, Connecticut 06510, United States
    Recruiting
    • Noffar Bar, Site 0029 · Contact000-000-0000
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Recruiting
    • David Siegel, Site 0028 · Contact551-996-8704
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
    • Jing Christine Ye, Site 0005 · Contact734-232-0744
  • Arthur J E Child Comprehensive Cancer Centre
    Calgary, Alberta T2N 5G2, Canada
    Recruiting
    • Nizar Bahlis, Site 0032 · Contact4032202801
  • Local Institution - 0026
    Vancouver, British Columbia V5Z 4E6, Canada
    Not yet recruiting
    • Site 0026 · Contact
  • QEII Health Sciences Centre - Victoria General Site
    Halifax, Nova Scotia B3H 2Y9, Canada
    Recruiting
    • Darrell White, Site 0027 · Contact9024734642
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
    Recruiting
    • Guido Lancman, Site 0024 · Contact4169462059
  • Local Institution - 0030
    Suzhou, Jiangsu 215006, China
    Not yet recruiting
    • Site 0030 · Contact
  • Tongji University - Shanghai Fourth People's Hospital
    Shanghai, Shanghai Municipality 200434, China
    Recruiting
    • Weijun Fu, Site 0031 · Contact+8613816052522
  • Universitaetsklinikum Carl Gustav Carus Dresden
    Dresden, 01307, Germany
    Recruiting
    • Raphael Teipel, Site 0015 · Contact493514582583
  • Universitaetsklinikum Hamburg-Eppendorf
    Hamburg, 20246, Germany
    Recruiting
    • Katja Weisel, Site 0013 · Contact4940741058787
  • Universitaetsklinikum Heidelberg
    Heidelberg, 69120, Germany
    Recruiting
    • Marc-Steffen Raab, Site 0014 · Contact496221565427
  • Evangelismos General Hospital of Athens
    Athens, Attikí 106 76, Greece
    Recruiting
    • Sosana Delimpasi, Site 0011 · Contact6944822722
  • Alexandra General Hospital of Athens
    Athens, Attikí 115 28, Greece
    Recruiting
    • MELETIOS DIMOPOULOS, Site 0012 · Contact+306932418798
  • St. Olavs Hospital
    Trondheim, Sør-Trøndelag 7030, Norway
    Recruiting
    • Tobias Slordahl, Site 0017 · Contact004791145009
  • Sykehusapoteket Ull
    Oslo, 0450, Norway
    Recruiting
    • Fredrik Hellem Schjesvold, Site 0019 · Contact+4799697796
  • Hospital Universitario Marqués de Valdecilla
    Santander, Cantabria 39008, Spain
    Recruiting
    • Enrique Ocio, Site 0021 · Contact+34649391848
  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
    Salamanca, 37007, Spain
    Recruiting
    • Maria Victoria Mateos Manteca, Site 0022 · Contact34923291100
  • University College London Hospital
    London, England W1T 7HA, United Kingdom
    Recruiting
    • Selina Chavda, Site 0016 · Contact02034472929
  • Royal Marsden Hospital (Sutton)
    London, Sutton SM2 5PT, United Kingdom
    Recruiting
    • Charlotte Pawlyn, Site 0018 · Contact02087224000
  • The Christie NHS Foundation Trust
    Manchester, M20 4BX, United Kingdom
    Recruiting
    • Emma Searle, Site 0020 · Contact+447917554940
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06988488
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
May 25, 2025
Start date
Oct 7, 2025
Primary completion
May 31, 2027 (estimated)
Completion
Jun 3, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Elranatamab · Mezigdomide

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