Estudio aleatorizado de fase 3 que compara talquetamab en combinación con pomalidomida (Tal-P), talquetamab en combinación con teclistamab (Tal-Tec) y la elección del investigador entre elotuzumab, pomalidomida y dexametasona (EPd) o pomalidomida, bortezomib y dexametasona (PVd) en participantes con mieloma recidivante o refractario que han recibido entre 1 y 4 líneas previas de tratamiento, incluido un anticuerpo anti-CD38 y lenalidomida

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06208150Tipo: INTERVENTIONALInicio: 22 de ene de 2024Fin estimado: 31 de mar de 2028

Resumen

El propósito de este estudio es comparar la efectividad de talquetamab más pomalidomida (Tal-P) o talquetamab más teclistamab (Tal-Tec) frente a elotuzumab, pomalidomida y dexametasona (EPd) o pomalidomida, bortezomib y dexametasona (PVd).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level \>= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (\>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (\<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment
Documented evidence of PD or failure to achieve a minimal response to the last line of therapy 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 immediately prior to the start of administration of study treatment
A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment

Criterios de exclusión

Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
A maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Intervenciones

drug

Talquetamab

Talquetamab will be administered as a SC injection.

drug

Pomalidomide

Pomalidomide will be administered orally.

drug

Teclistamab

Teclistamab will be administered as a SC injection.

drug

Elotuzumab

Elotuzumab will be administered intravenously.

drug

Dexamethasone

Dexamethasone will be administered either orally or intravenously.

drug

Bortezomib

Bortezomib will be administered as a SC injection.

Ubicaciones

Fundaleu

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Hospital Aleman

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

COMPLETED

Patrocinadores

PrincipalJanssen Research & Development, LLC

Contactos

Study Contact

CONTACT

Participate-In-This-Study1@its.jnj.com 844-434-4210

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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