A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma (TRIlogy-4)
Multiple Myeloma
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
Inclusion:
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
- MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
- Measurable disease at screening as assessed by central laboratory
- Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody
- Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator’s determination of response by IMWG criteria
- Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration
Exclusion:
- Active hepatitis of infectious origin
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
- Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab
- Major surgery, (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, or during study treatment
Louise Hay
louise.hay@health.wa.gov.au
08 6383 3207
Janssen Research & Development, LLC
Phase 3
JNJ-79635322
NCT07258511
