Comparing two treatment combinations for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of mezigdomide combined with bortezomib and dexamethasone (MeziVd) against a different combination of pomalidomide, bortezomib, and dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma. Participants must have received 1 to 3 prior lines of therapy and have had previous exposure to lenalidomide. The study aims to determine which treatment combination provides better outcomes for patients with measurable disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• TUM Klinikum
  München, Bavaria, Germany Recruiting
• Klinikum Traunstein
  Traunstein, Bavaria, Germany Recruiting
• Medizinisches Versorgungszentrum
  Weiden, Bavaria, Germany Recruiting
• Universitaetsklinik Marburg
  Marburg, Hesse, Germany Recruiting
• Praxis Onkologie am Raschplatz
  Hanover, Lower Saxony, Germany Recruiting
• Universitätsklinikum Bonn
  Bonn, North Rhine-Westphalia, Germany Recruiting

+216 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.