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
European Myeloma Network B.V.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 treat…
Interventions
- DrugTeclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
- DrugLenalidomide
Lenalidomide will be administered orally
Locations (211)
- Banner University Medical Center Tucson, University of ArizonaPhoenix, Arizona
- UCLA Medical CenterLos Angeles, California
- University of California-Davis Cancer CenterSacramento, California
- University of California, San Diego (UCSD) Medical CenterSan Diego, California
- University of Colorado HospitalAurora, Colorado
- Colorado Blood Cancer InstituteDenver, Colorado