Calendario›SNY›isatuximab SAR650984 · IONA-MM
isatuximab SAR650984 · IONA-MM
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Ensayo de Sanofi en Plasma Cell Myeloma (del registro, en inglés).
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 583
- Centros
- 129
- Fin del objetivo primario
- feb 2026
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en ago 2020.
Qué mide
Overall response rate (ORR) (del registro, en inglés) (12 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event \[AE\] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04458831), actualizada en jul 2026.