Myélome

TITRE (EN) 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-1
CLINICAL TRIAL.gov ID NCT05519085
TYPE(S) DE CANCER Myélome
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Marc Lalancette
COORDONATEUR(RICE) Patricia Chabot
patricia.chabot@chudequebec.ca
418-525-4444 poste 15769
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

  • 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.
CRITÈRES D'EXCLUSION (EN)
  • 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.