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Recruiting Phase 3

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT05519085 · tracked via the Priya Life Science UK tracker
Sponsor
Phase
Phase 3
Started
2022-09-20
Last updated
2026-10-30

Condition(s) studied

Relapsed or Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

mezigdomide →Pomalidomide →Bortezomib →Dexamethasone →

mezigdomide: Specified dose on specified days

Pomalidomide: Specified dose on specified days

Bortezomib: Specified dose on specified days

Dexamethasone: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (266)

FacilityCityRegionStatus
Local Institution - 0366 Los Alamitos California Active Not Recruiting
Local Institution - 0272 San Diego California Completed
Local Institution - 0273 West Hollywood California Completed
Local Institution - 0381 Aurora Colorado Not Yet Recruiting
Local Institution - 0380 Farmington Connecticut Completed
Local Institution - 0208 New Haven Connecticut Withdrawn
Local Institution - 0303 Coral Springs Florida Active Not Recruiting
Local Institution - 0403 Fort Myers Florida Completed
Local Institution - 0401 Orange City Florida Active Not Recruiting
Local Institution - 0402 West Palm Beach Florida Active Not Recruiting
Local Institution - 0211 Athens Georgia Active Not Recruiting
Local Institution - 0048 Marietta Georgia Withdrawn
Local Institution - 0330 Garden City Kansas Completed
Local Institution - 0080 Westwood Kansas Active Not Recruiting
Local Institution - 0358 Baton Rouge Louisiana Active Not Recruiting
Local Institution - 0255 New Orleans Louisiana Active Not Recruiting
Local Institution - 0385 Shreveport Louisiana Not Yet Recruiting
Local Institution - 0357 Baltimore Maryland Completed
Local Institution - 0246 Boston Massachusetts Active Not Recruiting
Local Institution - 0271 Ann Arbor Michigan Active Not Recruiting
Local Institution - 0364 Detroit Michigan Completed
Local Institution - 0410 Minneapolis Minnesota Active Not Recruiting
Local Institution - 0088 Hattiesburg Mississippi Active Not Recruiting
Local Institution - 0242 Jackson Mississippi Withdrawn
Local Institution - 0288 East Brunswick New Jersey Active Not Recruiting
Local Institution - 0363 Ridgewood New Jersey Not Yet Recruiting
Local Institution - 0302 Albuquerque New Mexico Active Not Recruiting
Local Institution - 0245 Buffalo New York Withdrawn
Local Institution - 0257 Lake Success New York Active Not Recruiting
Local Institution - 0373 New Hyde Park New York Completed
Local Institution - 0371 New York New York Completed
Local Institution - 0108 Rochester New York Active Not Recruiting
Local Institution - 0374 Shirley New York Completed
Local Institution - 0372 The Bronx New York Completed
Local Institution - 0274 Williamsville New York Withdrawn
Local Institution - 0260 Durham North Carolina Active Not Recruiting
Local Institution - 0400 Cincinnati Ohio Completed
Local Institution - 0377 Cleveland Ohio Active Not Recruiting
Local Institution - 0076 Cleveland Ohio Active Not Recruiting
Local Institution - 0376 Mayfield Heights Ohio Completed

+ 226 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05519085 on ClinicalTrials.gov ↗ ← All trials in the UK