Clinical Trial 23819

• Overview

  Study 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

  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.

  Objective:

  The primary objective of this study is to compare the efficacy of teclistamab in combination with lenalidomide (Tec-Len) with that of lenalidomide monotherapy (Len), and the efficacy of teclistamab monotherapy (Tec) with that of lenalidomide monotherapy (Len) in the maintenance setting, as assessed by PFS and 12-month MRD-negative CR.

• Inclusion Criteria

  Key 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.
  • Enrolling at Memorial Healthcare system only.

• Exclusion Criteria

  Key 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.
  • Enrolling at Memorial Healthcare system only.

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