Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-23-035
Prinicipal Investigator
Naik, Seema
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
64407564MMY3009
Title
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P),Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide. MonumenTAL-6
Objective
Primary Objective: to compare the efficacy of either Tal-P or Tal-Tec with EPd or PVd.

Secondary Objectives: To further compare the efficacy of either Tal-P or Tal-Tec with EPd or PVd. To characterize the PK of talquetamab and teclistamab. To assess the immunogenicity of talquetamab and teclistamab. To assess participants symptoms,
functioning, and HRQoL with Tal-P, Tal-Tec, and EPd or PVd.
Applicable Disease Sites
Multiple Myeloma
Status
Open
Participating Institutions
Hershey Medical Center