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Isatuximab SAR650984 · IMROZ
A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Ensayo de Sanofi en Mieloma de celulas plasmaticas.
- Fase
- Fase 3
- Estado
- En marcha, sin reclutar
- Participantes
- 475
- Centros
- 104
- Fin del objetivo primario
- abr 2027
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en dic 2017.
Qué mide
Supervivencia libre de progresion (PFS) (Up to approximately 100 months after the First Participant In (FPI)) (del registro, en inglés)
Qué se prueba
Se prueba isatuximab en combinacion con bortezomib, lenalidomida y dexametasona frente a bortezomib, lenalidomida y dexametasona solos, en participantes con mieloma multiple recien diagnosticado no elegibles para trasplante.
Lo que dice el documentoTo demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.
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Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: * To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: * Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. * Minimal residual disease (MRD) negativity rate in participants with CR. * Very good partial response or better rate, as defined by the IMWG criteria. * Overall survival (OS). * To evaluate the overall response rate (ORR) as per IMWG criteria. * To evaluate the time to progression (TTP) overall and by MRD status. * To evaluate PFS by MRD status. * To evaluate the duration of response (DOR) overall and by MRD status. * To evaluate time to first response (TT1R). * To evaluate time to best response (TTBR). * To evaluate progression-free survival on next line of therapy (PFS2). * To evaluate the sustained MRD negativity \>12 months rate. * To evaluate safety. * To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only). * To evaluate the immunogenicity of isatuximab in participants receiving isatuximab (IVRd and crossover arms). * To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03319667), actualizada en abr 2026.