UPCC 58425 A Phase 2, Open-label Study of JNJ-79635322 in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody (TRIlogy-3)

Investigational Medication Study for Relapsed or Hard-to-Treat Multiple Myeloma

Enrolling By Invitation
18 years or above
All
Phase 2
157 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma
  • Age: 18 years or above
  • Gender: All

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

This study investigates relapsed or refractory multiple myeloma.

The study evaluates the effectiveness of an investigational medication in participants who have received at least three prior lines of therapy.

  • Who can participate: Participants must have a documented diagnosis of multiple myeloma and have received at least three prior lines of therapy. They should have an ECOG performance status of 0 to 2.
  • Study details: Participants will receive an investigational medication. Some may receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 06 Jul 2026. Study ID: 25-1888
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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