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

Age: 18 Years and older

Gender: All

Start Date: 09/08/2022

Primary Completion Date (Estimated): 04/01/2028

Study Completion Date (Estimated): 04/01/2032

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

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.

* 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.