Resumen

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Edad: 18 años o más

Género: Todos

Fecha de inicio: 09/08/2022

Fecha de finalización principal (estimada): 04/01/2028

Fecha estimada de finalización del estudio: 04/01/2032

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

Criterios de elegibilidad

Edad: 18 años o más

Género: Todos

Acepta voluntarios sanos: No

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.