A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
590 patients around the world
Available in United States, Brazil, Spain
Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab
(JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine
(PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor
expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual
binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to
BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive
cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts
potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a
second-generation proteasome inhibitor that inhibits proteasome which results in
disruption of protein turnover and induces apoptosis. The primary hypothesis of this
study is that teclistamab monotherapy (Arm A) will significantly improve progression free
survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) 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. The study will
include a screening phase, treatment phase, and follow-up phase. Safety will be assessed
by physical examinations, neurologic examinations, eastern cooperative oncology group
(ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The
overall duration of the study will be up to 9 years.