Study # MajesTEC-9
A Phase III Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
A Phase III Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
Meta
Study Status:
Enrolling
Treatment Agent:
Teclistamab, Pomalidomide, Bortezomib, Dexamethasone, Carfilzomib
Description
Short Title: MajesTEC-9
This is a 2-part, multicenter, open-label study in participants with multiple myeloma who have previously received 1 to 3 prior line(s) of therapy.
Part 1 is a Phase III randomized study comparing teclistamab monotherapy versus investigator’s choice of PVd or Kd in participants with relapsed or refractory multiple myeloma. Part 2 is a single-arm cohort (teclistamab monotherapy) to evaluate the safety, efficacy, and PK of an alternative step-up dosing schedule for teclistamab.
Resources and Links
National Clinical Trial Identified Number: NCT05572515