Study on JNJ-79635322 for Patients with Relapsed or Refractory Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT07266441

This clinical trial is testing a new treatment, JNJ-79635322, to see how well it works for patients with multiple myeloma that has either returned after treatment or did not respond to previous treatments. Participants must have already tried at least three different therapies.

Patient Parameters

Program Overview

The goal of this study is to determine the effectiveness of a new drug, JNJ-79635322, in treating patients with multiple myeloma, a type of cancer affecting plasma cells in the blood. The study focuses on patients whose cancer has either come back after treatment (relapsed) or has not responded to treatment (refractory). To participate, patients must have previously undergone at least three different treatment regimens.

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 monoclonal antibody (mAb)

  • 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 the 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 (PS) of 0 to 2 at screening and immediately before the start of study treatment administration

Exclusion:

  • Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322
  • Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase
  • Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
  • Participant has leptomeningeal disease
  • Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment

Locations

FACILITYZIPCITYSTATE
O Neal Comprehensive Cancer Center at UAB35294BirminghamAlabama
Banner MD Anderson Cancer Center85234GilbertArizona
City of Hope91010DuarteCalifornia
City of Hope Orange County Lennar Foundation Cancer Center92618IrvineCalifornia
Cancer and Blood Specialty Clinic90720Los AlamitosCalifornia
University of California San Francisco94143San FranciscoCalifornia
Rocky Mountain Cancer Centers80012AuroraColorado
Colorado Blood Cancer Institute80218DenverColorado
Cancer Specialists of North Florida32256JacksonvilleFlorida
Emory University30322AtlantaGeorgia

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