A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT07266441

This study assesses the efficacy of JNJ-79635322, administered subcutaneously, in patients with Relapsed or Refractory Multiple Myeloma who have undergone at least three prior therapies. Participants must meet specific eligibility criteria related to their treatment history and health status to qualify for this clinical trial.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.

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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.