Groupe d'Etude en Oncologie du Quebec

Titre	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
Protocole ID	SUCCESSOR-1 (CA057-001)
ClinicalTrials.gov ID	NCT05519085
Type(s) de cancer	Myélome
Phase	Phase III
Stade	Récidivant/réfractaire (2ième ligne de traitement et plus)
Type étude	Clinique
Médicament	Mezigdomide, Bortézomib et Dexaméthasone versus Pomalidomide, Bortézomib et Dexaméthasone
Institution	CISSS DE LA MONTEREGIE-CENTRE HOPITAL CHARLES-LE MOYNE 3120 boulevard Taschereau, Greenfield Park, QC, J4V2H1
Ville	Greenfield Park
Investigateur(trice) principal(e)	Dre Sabrina Trudel
Coordonnateur(trice)	Fanny Raquepas Trudel 450-466-5000 poste 3593
Statut	Actif en recrutement
Date d'activation	05-06-2023
Critètes d'éligibilité	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.
Critètes d'exclusion	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.

Groupe d'étude en oncologie du Québec