Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Korábbi kezelés

• 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).
• 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.

Egyéb

• Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.

• 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.