A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
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
Janssen Research & Development, LLC
157 participants
Feb 8, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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 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 Criteria5
- 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
Interventions
JNJ-79635322 will be administered as an injection under the skin.
Locations(23)
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NCT07266441