Estudio multicéntrico, aleatorizado, de etiqueta abierta, de fase 3, para comparar la eficacia y seguridad de arlocabtagene autoleucel (BMS-986393), una terapia con células CAR-T dirigida a GPRC5D, frente a regímenes estándar en participantes adultos con mieloma múltiple recidivante o refractario expuesto a lenalidomida

ReclutandoFase 3ClinicalTrials.gov

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

Resumen

El propósito de este estudio es comparar la eficacia y seguridad de arlo-cel (BMS-986393) frente a regímenes estándar en participantes adultos con mieloma múltiple recidivante o refractario expuesto a lenalidomida.

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.