Myélome

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  • SUCCESSOR-01/CA057-001

TITRE Étude de phase III, multicentrique, ouverte, à répartition aléatoire et en deux étapes visant à comparer l’association 480Vd (CC-92480, bortézomib et dexaméthasone) et l’association PVd (pomalidomide, bortézomib et dexaméthasone) chez des sujets atteints d’un myélome multiple récidivant ou réfractaire (MMRR)
PROTOCOLE ID SUCCESSOR-01/CA057-001
CLINICAL TRIAL.gov ID NCT05519085
TYPE(S) DE CANCER Myélome
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CIUSSS DU NORD-DE-L'ILE-DE-MONTREAL
555 boulevard Gouin O
(514) 331-3020
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Jean-Samuel Boudreault-Pedneault
COORDONATEUR(RICE) Maia Labelle
514-338-2222 poste 2818
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.