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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

RecruitingPhase 3

Sponsor: Celgene

Conditions: Relapsed or Refractory Multiple Myeloma

Interventions: mezigdomide, Pomalidomide, Bortezomib, Dexamethasone

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (266)

Los Alamitos, California, United States
San Diego, California, United States
West Hollywood, California, United States
Aurora, Colorado, United States
Farmington, Connecticut, United States
New Haven, Connecticut, United States
Coral Springs, Florida, United States
Fort Myers, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Athens, Georgia, United States
Marietta, Georgia, United States
Garden City, Kansas, United States
Westwood, Kansas, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Hattiesburg, Mississippi, United States
Jackson, Mississippi, United States
East Brunswick, New Jersey, United States
Ridgewood, New Jersey, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
Lake Success, New York, United States
New Hyde Park, New York, United States
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