Open Actively Recruiting

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

About

Brief Summary

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.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
Study Stats
Protocol No.
26-0290
Category
Multiple Myeloma
Principal Investigator
Sarah M. Larson, MD
Sarah M. Larson, MD
Hematologic Malignancy
Sarah M. Larson, MD
Contact
  • River Sween
Location
  • UCLA San Luis Obispo
  • UCLA Santa Barbara
  • UCLA Santa Monica
  • UCLA Westlake Village
For Providers
NCT No.
NCT07258511
For detailed technical eligibility, visit ClinicalTrials.gov.