TITRE | (EN) 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) |
CLINICAL TRIAL.gov ID | NCT05519085 |
TYPE(S) DE CANCER | Myélome |
PHASE | Phase III |
TYPE D'ÉTUDE | Clinique |
INSTITUTION |
CSSS CHAMPLAIN
3120 boulevard Taschereau (450) 466-5000 |
VILLE | Greenfield Park |
INVESTIGATEUR(RICE) PRINCIPAL(E) | Sabrina Trudel |
COORDONATEUR(RICE) |
Fanny Raquepas Trudel fanny.raquepas-trudel.cisssmc16@ssss.gouv.qc.ca 450-466-5000 poste 3593 |
STATUT | Actif en recrutement |
CRITÈRES D'ÉLIGIBILITÉ | (EN) 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.
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CRITÈRES D'EXCLUSION | (EN) 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.
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