Calendario›SNY›isatuximab SAR650984
isatuximab SAR650984
SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients
Ensayo de Sanofi en Plasma Cell Myeloma (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 57
- Centros
- 5
- Fin del objetivo primario
- jun 2023
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, abierto. Comenzó en feb 2013.
Qué mide
Number of patients with adverse events when treated with SAR650984 (isatuximab) in combination with LD (Up to 30 days for patients experiencing progressive disease and continuously while patients are on treatment) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: * To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma. * Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity (objective response rate \[ORR\]) of SAR650984 (isatuximab) in combination with LD using International Myeloma Working Group (IMWG) criteria. Secondary Objectives: * To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in combination with LD in relapsed or refractory multiple myeloma. The severity, frequency and incidence of all toxicities will be assessed. * To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in combination with LD and the PK of lenalidomide in combination with SAR650984 and dexamethasone. * To assess the relationship between clinical (adverse event \[AE\] and/or tumor response) effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative laboratory) results. * For the dose expansion phase, estimate the activity (ORR) using IMWG defined response criteria of SAR650984 (isatuximab) plus LD. * To describe progression-free survival (PFS) in patients treated with this combination.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01749969), actualizada en jul 2023.