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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 (that is partial response [PR] or better) to the last line of therapy based on investigator's determination of response by IMWG criteria

  • Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent

  • 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, during, or within 90 days after the last dose of study treatment
Investigators
Locations
Emory University Hospital Midtown
Winship Cancer Institute
View on ClinicalTrials.gov