Un Estudio de Fase 3, Aleatorizado, que Compara Teclistamab en Combinación con Daratumumab SC (Tec-Dara) versus Daratumumab SC, Pomalidomida y Dexametasona (DPd) o Daratumumab SC, Bortezomib y Dexametasona (DVd) en Participantes con Mieloma Múltiple Recaído o Refractario

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05083169Tipo: INTERVENTIONALInicio: 14 de oct de 2021Fin estimado: 8 de dic de 2028

Resumen

El propósito de este estudio es comparar la eficacia de teclistamab con daratumumab (Tec-Dara) frente a daratumumab subcutáneo (SC) en combinación con pomalidomida y dexametasona (DPd) o daratumumab SC en combinación con bortezomib y dexametasona (DVd).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
Have clinical laboratory values within the specified range

Criterios de exclusión

A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG,
A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade \>= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
Received any prior B cell maturation antigen (BCMA)-directed therapy
Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days before randomization
Received a live, attenuated vaccine within 4 weeks before randomization
Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

Intervenciones

drug

Daratumumab

Daratumumab will be administered SC injection.

drug

Pomalidomide

Pomalidomide will be administered orally.

drug

Dexamethasone

Dexamethasone will be administered orally or intravenously.

drug

Bortezomib

Bortezomib will be administered SC injection.

drug

Teclistamab

Teclistamab will be administered SC injection.

Ubicaciones

Hospital Aleman

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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