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.

  • Participants received 1 to 3 prior lines of antimyeloma therapy.
  • Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.
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.

  • 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.