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.
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.
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.
European Myeloma Network B.V.
Lead sponsor
Janssen Pharmaceutica
Collaborator