drugset / Trial / NCT05317416

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

NCT05317416

Phase 3 Active not recruiting 854 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Timeline

Start
2022-03-25
Primary completion
2027-08-04
Completion
2029-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Elranatamab Monoclonal antibody Subcutaneous
Comparator Lenalidomide Other / unclassified Oral

Indications