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Recruiting

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants - CA056-1060

Mis à jour: 17 décembre, 2024   |   ClinicalTrials.gov

Impression du resumé

SONGEZ-VOUS À PARTICIPER À CET ESSAI?
Imprimez cette page et le guide pour vous aider dans vos échanges avec votre médecin.
Utilisez le guide en matière d’essai pour connaître le processus de participation à un essai clinique. Soyez au fait des principaux facteurs à considérer avant de prendre une décision et dressez la liste des questions à poser à l’équipe de soins de santé.

Détails de l’essai

  • Phase 3

    Phase

  • Sexe(s)

  • 18+

    Tranche d’âge

  • 45

    Emplacement(s)

  • Recruiting

Options de traitement

Groupes de l’étude
INTERVENTION ATTRIBUÉE
Experimental: Cohort 1: erythropoiesis-stimulating agents (ESA) naïve
Drug: Luspatercept
Experimental: Cohort 2: ESA relapsed or refractory
Drug: Luspatercept

Principaux critères d’admissibilité

Inclusion Criteria: - Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. - Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. - Participant must have red blood cell transfusions according to study criteria. Exclusion Criteria: - Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. - Participant has had a prior allogeneic or autologous stem cell transplant. - Participant has known history or diagnosis of AML. - Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply

Nous vous recommandons fortement de contacter BMS pour signaler les effets secondaires (événements indésirables).
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici.
Signaler des effets secondaires (effets indésirables) ou des plaintes concernant la qualité du produit: Informations médicales

Des questions? Le support en direct est disponible 24/7 - Veuillez composer le 833-673-6134 ou Envoyez-nous un courriel

Des questions? Le support en direct est disponible 24/7 -
Veuillez composer le 833-673-6134 ou Envoyez-nous un courriel