Les informations présentées dans l’Outil de recherche personnalisé d’essais cliniques de Myélome Canada sont issues de la base de données des essais cliniques internationaux du site ClinicalTrials.gov, répertoriées par la U.S. National Library of Medicine. Bien que le menu soit en français, les détails des études ne sont offerts qu’en anglais.
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A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (SUCCESSOR-1)

*Les informations de l'essai contenues sur cette page ont été récupérées du site ClinicalTrials.gov. Cliquez ici pour voir cet essai sur ClinicalTrials.gov.

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Titre complet:
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 (RRMM): SUCCESSOR-1
Stade ou Condition:
Relapsed or Refractory Multiple Myeloma
Phase d'étude:
Phase 3
Résumé:
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
Description détaillée:
Non disponible
Traitements:
Drug : mezigdomide

Specified dose on specified days

Drug : Pomalidomide

Specified dose on specified days

Drug : Bortezomib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Groupes d'étude:
Experimental : MeziVd (mezigdomide, bortezomib and dexamethasone)
Experimental : PVd (pomalidomide, bortezomib and dexamethasone)
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Statut du recrutement:
En cours
Critères d'admissibilités:
sion Criteria
  • 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. Exclusion Criteria
  • 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 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.
    • Lieux / Centres:

    Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Greenfield Park, Quebec – En cours

    Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur, Montreal, Quebec – En cours

    Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus, Quebec City, Quebec – En cours

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    Date d’affichage:
    2022-08-29
    Date de début:
    September 20, 2022
    Dernière mise à jour:
    2024-05-02
    Nombre d'inscriptions anticipées:
    810
    Date de fin prévue:
    2033-11-30
    Date de fin prévue de l'étude primaire:
    2025-11-03
    Condition:
    Relapsed or Refractory Multiple Myeloma
    Genre:
    All
    Âge:
    18 Years-N/A
    Accepte des bénévoles en santé:
    No
    Pays participants:
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Czechia
    Finland
    France
    Germany
    Greece
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Poland
    Portugal
    Puerto Rico
    Romania
    Spain
    Turkey
    United Kingdom
    United States
    Numéro d’identification:
    NCT05519085
    Autres numéros d'identification de l'étude:
    CA057-001
    Comité de suivi des données:
    Yes
    Produit réglementé par la FDA (É-U):
    Yes
    IPD Sharing Statement :
    ???
    Responsables de l’étude:
    Sponsor
    Commanditaires de l’étude:
    lead_sponsor
    Celgene
    Industry
    Collaborators:
    ???
    Chercheurs:
    Bristol-Myers Squibb Bristol-Myers Squibb
    Protocol Registration and Results System:
    ???
    Date de vérification:
    2024-05-01