Title
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 - MajesTEC-4

Description
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 - MajesTEC-4

Objective
Primary: To compare the efficacy of Tec-Len to Len, and the efficacy of Tec to Len in the maintenance setting.

Treatment 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.

Key Eligibility 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.

Applicable Disease Sites
Multiple Myeloma

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital