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Teclistamab and Lenalidomide for Newly Diagnosed Multiple Myeloma After Stem Cell Transplant

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

PHASE3 · European Myeloma Network B.V. · NCT05243797

This study is testing if a new treatment combining teclistamab with lenalidomide can help people with newly diagnosed multiple myeloma stay in remission longer after a stem cell transplant compared to just using lenalidomide alone.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1594 (estimated)
Ages18 Years and up
SexAll
SponsorEuropean Myeloma Network B.V. (network)
Drugs / interventionschimeric antigen receptor, prednisone, teclistamab
Locations211 sites (Phoenix, Arizona and 210 other locations)
Trial IDNCT05243797 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, open-label Phase 3 study evaluates the effectiveness of teclistamab in combination with lenalidomide and teclistamab alone compared to lenalidomide alone as maintenance therapy for patients with newly diagnosed multiple myeloma following autologous stem cell transplantation. Participants must have achieved at least a partial response to their initial treatment and have not received prior maintenance therapy. The study aims to determine the benefits of these treatment combinations in prolonging remission and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with newly diagnosed multiple myeloma who have achieved at least a partial response after one line of therapy and have not received any maintenance treatment.

Not a fit: Patients who have previously received BCMA-directed therapy or any immune cell redirecting agents may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective maintenance therapy option for patients with newly diagnosed multiple myeloma, potentially leading to longer remission periods.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating multiple myeloma, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.
* 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.

Where this trial is running

Phoenix, Arizona and 210 other locations

+161 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Multiple Myeloma, Maintenance, Teclistamab

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.