Last updated 31 days ago
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
1572 patients around the world
Available in Brazil
European Myeloma Network
1Research sites
1572Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 treatmentHave clinical laboratory values within prespecified range.
- 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.
Sites
AC Camargo Cancer Center
Recruiting
StudyMajesTEC-4
SponsorEuropean Myeloma Network
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05243797
