A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Recruiting now · Phase 3
Conditions studied: Relapsed or Refractory Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT05519085
- Run by
- Celgene
- People needed
- 810
- Starts
- 2022-09-20
- Expected to finish
- 2033-11-30
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Centre Hospitalier Universitaire Estaing — Clermont-Ferrand, France (enrolling)
- Universitaetsklinik Marburg — Marburg, Hesse, Germany (enrolling)
- Instituto Joinvilense de Hematologia e Oncologia — Joinville, Santa Catarina, Brazil (enrolling)
- Hopital Claude Huriez - CHU de Lille — Lille, Nord, France (enrolling)
- Hôpital Saint Antoine — Paris, Île-de-France Region, France (enrolling)
- Medizinisches Versorgungszentrum — Weiden, Bavaria, Germany (enrolling)
- AZ Nikolaas — Sint-Niklaas, Oost-Vlaanderen, Belgium (enrolling)
- Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Clínica Médica São Germano S/S Ltda — São Paulo, Brazil (enrolling)
- Centre Leon Berard — Lyon Cedex08, Auvergne-Rhône-Alpes, France (enrolling)
- Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire Carémeau — Nîmes, France (enrolling)
- Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau — Tours, France (enrolling)
- TUM Klinikum — München, Bavaria, Germany (enrolling)
- Klinikum Traunstein — Traunstein, Bavaria, Germany (enrolling)
- Ziekenhuis Oost-Limburg, Campus St.-Jan — Genk, Limburg, Belgium (enrolling)
- UZ Gent — Ghent, Oost-Vlaanderen, Belgium (enrolling)
- ZNA Cadix — Antwerp, Belgium (enrolling)
- Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador — Salvador, Estado de Bahia, Brazil (enrolling)
- Hospital Amaral Carvalho — Jaú, São Paulo, Brazil (enrolling)
- Americas Centro de Oncologia Integrado — Rio de Janeiro, Brazil (enrolling)
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil (enrolling)
- Institut de cancérologie Strasbourg Europe (ICANS) — Strasbourg, Alsace, France (enrolling)
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren — Limoges, France (enrolling)
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes, France (enrolling)
- Praxis Onkologie am Raschplatz — Hanover, Lower Saxony, Germany (enrolling)
Full record on ClinicalTrials.gov
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