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

• Status: Not yet recruiting
• Trial end date: 2032-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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 versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Myeloma Network
• Collaborator: Janssen Pharmaceutica
• Treatments: Lenalidomide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 (see Appendix 12).

• Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines authorized for emergency use (eg. COVID-19) are allowed.