Recruiting
Phase 3

Mezigdomide vs. Pomalidomide

Sponsor:

Celgene

Code:

NCT05519085

Conditions

Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mezigdomide

Pomalidomide

Bortezomib

Dexamethasone

Study Details

Brief summary:

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Conditions

Relapsed or Refractory Multiple Myeloma

Study ID

NCT05519085

Start date

Sep 20, 2022

Status verified date

Mar, 2026

Completion date

Nov 30, 2033

Anticipated

Primary completion date

Jan 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.

i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.

ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.

  • Participants received 1 to 3 prior lines of antimyeloma therapy.
  • Participants achieved minimal response \[MR\] or better to at least 1 prior antimyeloma therapy.

Exclusion Criteria

\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.

i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.

ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.

  • For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
  • Participant has had prior treatment with mezigdomide or pomalidomide.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

810 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MeziVd (mezigdomide, bortezomib and dexamethasone)

experimental: PVd (pomalidomide, bortezomib and dexamethasone)

Interventions

mezigdomide

Specified dose on specified days

Pomalidomide

Specified dose on specified days

Bortezomib

Specified dose on specified days

Dexamethasone

Specified dose on specified days

Primary outcome measure

  • Progression-free Survival (PFS) [ Time Frame: From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years) ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Vu Phan, Site 0366

562-735-0602

Sharp Memorial Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Edward Huynh, Site 0272

858-939-6622

UConn Health

Recruiting

Farmington, Connecticut, United States, 06030

Contacts

Swarup Kumar, Site 0380

860-679-2100

Advanced Research

Recruiting

Coral Springs, Florida, United States, 33321

Contacts

Sumit Sawhney, Site 0303

954-302-3120

Florida Cancer Specialists - South

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Syed Zafar, Site 0403

239-274-9930

Florida Cancer Specialists - North

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Gustavo Fonseca, Site 0401

000-000-0000

Florida Cancer Specialists - East

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Shachar Peles, Site 0402

561-366-4100

University Cancer Blood Ctr

Recruiting

Athens, Georgia, United States, 30607

Contacts

PETROS NIKOLINAKOS, Site 0211

706-353-2990

University of Kansas Medical Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Al-Ola Abdallah, Site 0080

918-261-6196

Our Lady of the Lake RMC

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Marshall Stagg, Site 0358

225-765-3344

Sinai Hospital Of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Qiwei Gai, Site 0357

410-871-6400

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Paul Richardson, Site 0246

617-632-2104

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Matthew Pianko, Site 0271

734-647-0118

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Vrushali Dabak, Site 0364

313-916-2389

Minnesota Oncology Hematology, P.A.

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Sandeep Jain, Site 0410

952-892-7190

Hattiesburg Clinic Hematology/Oncology

Recruiting

Hattiesburg, Mississippi, United States, 39401

Contacts

John Hrom, Site 0088

601-261-1700

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Bruno Fang, Site 0288

301-435-5332

University of New Mexico Comprehensive Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Dulcinea Quintana, Site 0302

505-259-2370

Northwell Health/ RJ Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Maria Nieto, Site 0257

516-734-8900

Rochester General Hospital

Recruiting

Rochester, New York, United States, 14621

Contacts

Saad Jamshed, Site 0108

585-922-4020

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Contacts

Richard Zuniga, Site 0374

631-675-5075

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Cristina Gasparetto, Site 0260

919-668-8222

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Kruti Patel, Site 0400

888-961-4156

Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Faiz Anwer, Site 0377

520-694-8900

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Faiz Anwer, Site 0076

520-694-8900

Cleveland Clinic - Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Faiz Anwer, Site 0376

520-694-8900

Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Bradley Lash, Site 0359

610-402-7890

The West Clinic, PLLC dba West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Jason Chandler, Site 0223

901-683-0055

Texas Oncology - West Texas

Recruiting

Abilene, Texas, United States, 79606

Contacts

Praveen Tumula, Site 0378

806-358-8654

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Robert Orlowski, Site 0275

713-304-7746

Mays Cancer Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Matthew Butler, Site 0267

210-450-1818

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Angel Mier-Hicks, Site 0409

210-595-5300

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84106

Contacts

Stephan Kendall, Site 0207

801-462-1053

Hematology Oncology Associates of Fredericksburg

Recruiting

Fredericksburg, Virginia, United States, 22408

Contacts

Christopher Vaughn, Site 0297

540-371-0079

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

JARED KOBULNICKY, Site 0408

757-873-9400

Blue Ridge Cancer Care

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Amanda Gillespie-Twardy, Site 0399

540-982-0237

VA Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

Nicholas Burwick, Site 0268

206-764-2036

Northwest Cancer Specialists, P.C.

Recruiting

Vancouver, Washington, United States, 98684

Contacts

Tristan Bice, Site 0411

360-944-9889

More Information

Sponsor

Celgene

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • Multiple myeloma
  • RRMM
  • MeziVd
  • PVd
  • CC92480
  • pomalidomide
  • bortezomib
  • dexamethasone
  • mezigdomide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Celgene on 2026-03-24.