Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official 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

Keywords

Multiple Myeloma, Maintenance, Teclistamab, Plasma Cell Neoplasms, Lenalidomide, Teclistamab-Lenalidomide (Tec-Len)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California-Davis Cancer Center accepting new patients
    Sacramento California 95817 United States
  • The University of Arizona Cancer Center accepting new patients
    Phoenix Arizona 85004 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stichting European Myeloma Network
ID
NCT05243797
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1594 study participants
Last Updated