A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06615479Tipo: INTERVENTIONALInicio: 12 de mar de 2025Fin estimado: 22 de jun de 2032

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Resumen

The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have relapsed or refractory multiple myeloma (RRMM).
Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.
Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
Participants must have measurable disease during screening.
Participants must have adequate organ function.
Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.

Criterios de exclusión

Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
Participants must not need urgent treatment due to rapidly progressing MM.