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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Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM) (MagnetisMM15)

*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:
ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Phase 4
Résumé:
This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.
Description détaillée:
This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.
Traitements:
Drug : Elranatamab

Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

Groupes d'étude:
Experimental : Elranatamab
Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Statut du recrutement:
En cours
Critères d'admissibilités:
Inclusion Criteria:
  • Participants must agree to follow the reproductive criteria as outlined in the protocol
  • Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).
Exclusion Criteria:
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.
Lieux / Centres:

Tom Baker Cancer Center, Calgary, Alberta – En cours

Cross Cancer Institute, Edmonton, Alberta – En cours

McGill University Health Centre, Montréal, Quebec – En cours

Contacts:
Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
Publications:
???
Date d’affichage:
2023-09-28
Date de début:
October 3, 2023
Dernière mise à jour:
2024-02-14
Nombre d'inscriptions anticipées:
72
Date de fin prévue:
2031-02-22
Date de fin prévue de l'étude primaire:
2031-02-22
Condition:
Multiple Myeloma
Genre:
All
Âge:
18 Years-N/A
Accepte des bénévoles en santé:
No
Pays participants:
Australia
Canada
France
Japan
United States
Numéro d’identification:
NCT06057402
Autres numéros d'identification de l'étude:
C1071015
Comité de suivi des données:
No
Produit réglementé par la FDA (É-U):
Yes
IPD Sharing Statement :
???
Responsables de l’étude:
Sponsor
Commanditaires de l’étude:
lead_sponsor
Pfizer
Industry
Collaborators:
???
Chercheurs:
Pfizer CT.gov Call Center Pfizer
Protocol Registration and Results System:
???
Date de vérification:
2024-02-01