Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma
Protocole ID	SUCCESSOR-01/CA057-001
ClinicalTrials.gov ID	NCT05519085
Type(s) de cancer	Myélome
Phase	Phase III
Type étude	Clinique
Médicament	CC-92480, bortézomib et dexaméthasone (480Vd) versus pomalidomide, bortézomib et dexaméthasone
Institution	CIUSSS DU NORD-DE-L'ILE-DE-MONTREAL HOPITAL DU SACRE-COEUR-DE-MONTREAL 5400 boul. Gouin Ouest, Montréal, QC, H4J1C5
Ville	Montréal
Investigateur(trice) principal(e)	Dr Jean-Samuel Boudreault-Pedneault
Coordonnateur(trice)	Maia Labelle 514-338-2222 poste 2818
Statut	Actif en recrutement
Date d'activation	02-02-2023
Critètes d'éligibilité	Participant has documented diagnosis of MM and measurable disease, defined as any of the following: M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP) 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. 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 CC-92480 or pomalidomide. Other protocol-defined criteria apply.

Groupe d'étude en oncologie du Québec