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RecruitingLast updated: 22 June 2026

MajesTEC-4: Testing different treatments to help prevent multiple myeloma from coming back after a stem cell transplant (maintenance therapy)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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

MajesTEC-4

Clinical summary

Summary

This study is looking at new ways to help prevent multiple myeloma from coming back after a stem cell transplant.

After a transplant, many people receive "maintenance treatment" (ongoing therapy to keep the cancer under control). The standard treatment is a drug called lenalidomide.

This trial is testing whether adding a newer targeted treatment called teclistamab, or using teclistamab on its own, works better than lenalidomide alone.

Who can take part?
You may be eligible if you have newly diagnosed multiple myeloma, have had initial treatment and a stem cell transplant, your cancer has responded to your first treatment (at least partially).

Study details
Eligible participants will be randomly assigned (by chance) to one of three treatment arms:

  • Arm A: teclistamab with lenalidomide
  • Arm B: lenalidomide alone
  • Arm C: teclistamab alone
 

Conditions

This trial is treating people with newly diagnosed Multiple Myeloma

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Stichting European Myeloma Network

Scientific 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

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