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Phase IIIInterventional

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

Protocol: 2026P000118NCT: NCT07258511

Overview

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.

Eligibility

Ages18 Years and older
SexAll
Healthy VolunteersNo
Age GroupsAdult, Older Adult

Inclusion:

  • Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:

    1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
    2. 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
Investigators
Locations
Emory University Hospital Midtown
Winship Cancer Institute
View on ClinicalTrials.gov