UPCC 02425 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)

Maintenance Therapies for Multiple Myeloma

Enrolling By Invitation
18 years or above
All
Phase 3
1594 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the effects of different maintenance therapies in people with newly diagnosed multiple myeloma. The purpose of this study is to compare the investigational medication teclistamab in combination with lenalidomide, teclistamab alone, and lenalidomide alone in maintaining health after a stem cell transplant.

Participants will be randomly assigned to one of three study arms to receive either the investigational medication teclistamab combined with lenalidomide, teclistamab alone, or lenalidomide alone. The study will involve regular assessments to monitor the effectiveness and safety of the treatments.

  • Who can participate: Adults who have been newly diagnosed with multiple myeloma and have received an autologous stem cell transplant may be eligible. Participants must have had only one line of therapy and show at least a partial response. They should not have received any prior maintenance therapy or certain types of immune therapies.
  • Study details: Participants will be randomly assigned to receive one of the treatments being studied. They will continue with their assigned treatment as maintenance therapy after their stem cell transplant. Participants will undergo regular health checks to assess the treatment's effects.
Updated on 28 Jul 2026. Study ID: 25-0541
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