Trial Filter

BETA

An intelligent search tool for clinical trials

Sign In
Back|NCT05243797Recruiting
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

Phase
Phase 3
Sponsor
European Myeloma Network B.V.
Enrollment
1,594
Timeline
Sep 2022 → Apr 2032
About This 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 Criteria

Inclusion Criteria

  • 1Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
  • 2Must 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.
  • 3Must not be intolerant to the starting dose of lenalidomide.
  • 4Must not have received any maintenance therapy.
  • 5Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
  • 6Have clinical laboratory values within prespecified range.

Exclusion Criteria

  • 1Received any prior BCMA-directed therapy.
  • 2Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
  • 3Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
  • 4Progressed on multiple myeloma therapy at any time prior to screening.
  • 5Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
  • 6Received 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

208 sites participating in this study

Emory University Hospital

Atlanta, Georgia 30322

Recruiting

Joseph

Banner University Medical Center Tucson, University of Arizona

Phoenix, Arizona 85004

Recruiting

Husnain

UCLA Medical Center

Los Angeles, California 90095

Recruiting

Schiller

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →