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Isatuximab SAR650984 · PomdeSAR

SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients

Ensayo de Sanofi en Plasma Cell Myeloma (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

54

previstos

Centros

13

Fin del objetivo primario

may 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2015.

Qué mide

Dose Limiting Toxicities (DLTs) (Part A: Up to 4 weeks) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: * To evaluate the infusion duration (Part B). * To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). * To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). * To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of pomalidomide when administered in combination (Part A). * To describe the efficacy of the combination of SAR650984 with Pd in terms of overall response rate and clinical benefit rate based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (Part A and B). * To assess the relationship between clinical effects (adverse event \[AE\] and/or tumor response) and CD38 receptor density at baseline (Part A).

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Ficha completa en ClinicalTrials.gov (NCT02283775), actualizada en jul 2021.