Study Comparing JNJ-79635322 with a BCMAxCD3 Antibody for Treating Relapsed or Refractory Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT07258511

This clinical trial is testing how well a new drug, JNJ-79635322, works compared to another treatment called a BCMAxCD3 bispecific antibody in patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The goal of this study is to find out if the new drug JNJ-79635322 is effective in treating patients with multiple myeloma that has either come back after treatment or has not responded to previous therapies. The study will compare the effects of JNJ-79635322 with those of a BCMAxCD3 bispecific antibody, which is another type of treatment for this condition.

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
USC Norris Comprehensive Cancer Center90033Los AngelesCalifornia
University of Connecticut Health Center06030FarmingtonConnecticut
Yale Cancer Center06510New HavenConnecticut
Florida Cancer Specialists & Research Institute33901Fort MyersFlorida
Moffit Cancer center33612TampaFlorida
Emory University30322AtlantaGeorgia
University of Iowa Hospital and Clinics52242Iowa CityIowa
Mission Cancer Blood50263WaukeeIowa
Norton Cancer Institute40207LouisvilleKentucky
Mount Sinai Brooklyn11234BrooklynNew York

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