Estudio de fase 3 de teclistamab en combinación con lenal... | EligiMed

Estudio de fase 3 de teclistamab en combinación con lenalidomida y teclistamab solo versus lenalidomida sola en participantes con mieloma múltiple de diagnóstico reciente como terapia de mantenimiento tras el trasplante autólogo de células madre - MajesTEC-4

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05243797Tipo: INTERVENTIONALInicio: 8 de sept de 2022Fin estimado: 1 de abr de 2032

Resumen

Este es un estudio multicéntrico, aleatorizado, abierto, de fase 3 en participantes con mieloma múltiple de diagnóstico reciente para evaluar los beneficios de teclistamab en combinación con lenalidomida y teclistamab solo versus lenalidomida sola como terapia de mantenimiento después del trasplante autólogo de células madre.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
Must not be intolerant to the starting dose of lenalidomide.
Must not have received any maintenance therapy.
Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
Have clinical laboratory values within prespecified range.

Criterios de exclusión

Received any prior BCMA-directed therapy.
Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
Progressed on multiple myeloma therapy at any time prior to screening.
Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.

Intervenciones

drug

Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC)

drug

Lenalidomide

Lenalidomide will be administered orally

Ubicaciones

Hospital Italiano

Buenos Aires, Argentina

Fantl

RECRUITING

Hospital Privado

Córdoba, Argentina

Caeiro

RECRUITING

Sanatorio Britanico Rosario

Rosario, Argentina

Funes

RECRUITING

Patrocinadores

PrincipalEuropean Myeloma Network B.V.

ColaboradorJanssen Pharmaceutica

Contactos

Christine Witty

CONTACT

Christine.Witty@emn.org +31 10 268 70 65

Sabrin Tahri

CONTACT

Sabrin.Tahri@emn.org +31 10 268 70 65

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