For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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.


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

EXCLUSION CRITERIA

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.


  1. 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.
  2. Participant has had prior treatment with mezigdomide or pomalidomide.
  3. * Other protocol-defined Inclusion/Exclusion criteria apply.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 855-907-3286Email iconEmail Study Center

Study Details


Contition

Relapsed or Refractory Multiple Myeloma

Age

18+

Phase

PHASE3

Participants Needed

810

Est. Completion Date

Nov 30, 2033

Treatment Type

INTERVENTIONAL


Sponsor

Celgene

ClinicalTrials.gov NCT Identifier

NCT05519085

Study Number

CA057001

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