Calendario›SNY›isatuximab SAR650984 IV

isatuximab SAR650984 IV

Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Ensayo de Sanofi en Mieloma multiple.

Más ensayos de: Mieloma múltiple.

Fase

Fase 1

Estado

Completado

Participantes

56

previstos

Centros

14

Fin del objetivo primario

mar 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2019.

Qué mide

Assessment of adverse events (AEs) (Baseline to 30 days after last study treatment administration (up to approximately 14 months after first study treatment administration)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objectives: * To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) * To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device * To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: * To estimate absolute bioavailability of SC and IV isatuximab * To measure receptor occupancy (RO) after isatuximab SC versus IV administration * To assess efficacy of isatuximab after SC and IV administration * To assess patient expectations prior to and patient experience and satisfaction after SC administration * To evaluate potential immunogenicity of SC or IV isatuximab

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04045795), actualizada en sep 2025.