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NCT05519085PHASE3RECRUITING

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

A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1

Sponsor: Celgene

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Key Facts

Study type
INTERVENTIONAL
Conditions
Relapsed or Refractory Multiple Myeloma
Interventions
mezigdomide, Pomalidomide, Bortezomib, Dexamethasone
Enrollment
810 participants
Primary completion
Jan 2027
Study completion
Nov 2033
First posted
Aug 2022
Last updated
May 2026

Primary Endpoints (CT.gov)

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)

Secondary Endpoints

Recommended mezigdomide dose

Plasma concentrations of mezigdomide

Overall Survival (OS)

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

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov