ReclutandoNCT07555938Registro de ClinicalTrials.gov

Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma

Multiple Myeloma

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 3
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 380 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.
Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible
MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide
Participants must have measurable disease during screening

Exclusion Criteria:

Known history of systemic light chain amyloidosis with major organ involvement (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)
Known history or current plasma cell leukemia
GI disease that might significantly alter absorption of oral drugs
Participants must not have any ongoing CNS disease or non-secretory myeloma

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

Cevostamab + Pomalidomide + Dexamethasone

Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards.

Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards.

Dexamethasone will be administered as a premedication prior to cevostamab.

Drug: Cevostamab · Drug: Pomalidomide · Drug: Dexamethasone

Standard of Care (SOC)

Participants will receive investigator's choice of one SOC regimen.

Drug: Pomalidomide · Drug: Dexamethasone · Drug: Daratumumab · Drug: Elotuzumab · Drug: Carfilzomib

Cevostamab DRUG

Participants will receive cevostamab IV as per the schedule given in the protocol.

Pomalidomide DRUG

Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.

Dexamethasone DRUG

Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.

Daratumumab DRUG

Participants will receive daratumumab SC as per the schedule given in the protocol.

Elotuzumab DRUG

Participants will receive elotuzumab IV as per the schedule given in the protocol.

Carfilzomib DRUG

Participants will receive carfilzomib IV as per the schedule given in the protocol.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.