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Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Friday, July 29, 2022
Researchers are currently recruiting patients for the multicenter phase III MajesTEC-3 trial, which is comparing the efficacy of the BCMA (B-cell maturation antigen)-CD3 bispecific antibody teclistamab (JNJ-64007957) plus the monoclonal antibody daratumumab with the investigator’s choice of therapy in patients with relapsed or refractory multiple myeloma. María-Victoria Mateos, MD, PhD, of Hospital Clínico Universitario de Salamanca, Spain, and colleagues shared the study design during the European Hematology Association (EHA) 2022 Congress (Abstract ).
“Although daratumumab plus pomalidomide and dexamethasone and daratumumab plus bortezomib and dexamethasone are approved for relapsed or refractory multiple myeloma, further disease control is still needed; thus, newer therapeutic options with diverse modes of action are warranted,” the investigators commented. “Teclistamab…induces T-cell activation and subsequent lysis of BCMA-expressing myeloma cells.”
The investigators plan to enroll approximately 560 adults with multiple myeloma who have measurable disease, an Eastern Cooperative Oncology Group performance status score between 0 and 2, previous exposure to up to three lines of treatment, and progressive disease status during or following their last treatment. Those who are refractory to an anti-CD38 monoclonal antibody or had prior BCMA-directed treatment will be excluded.
Patients will be randomly assigned in a 1:1 ratio to receive 28-day cycles of teclistamab plus daratumumab or the investigator’s choice of daratumumab plus pomalidomide and dexamethasone or daratumumab plus bortezomib and dexamethasone; they will be stratified by the investigator’s choice of therapy, International Staging System stage, and number of lines of prior treatment. The investigators identified progression-free survival as the primary endpoint. Overall response, complete response or better, measurable residual disease negativity, progression-free survival on the next line of treatment, overall survival, and incidence and severity of adverse events will be evaluated as secondary endpoints.
Disclosure: For full disclosures of the study authors, visit library.ehaweb.org.
