Home › Trials › NCT07266441

JNJ-79635322 for 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

Phase 2 Interventional Janssen Research & Development, LLC · NCT07266441

This trial will test whether JNJ-79635322 helps adults with relapsed or refractory multiple myeloma who have had at least three prior therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment157 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations37 sites (Birmingham, Alabama and 36 other locations)
Trial IDNCT07266441 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, open-label interventional trial testing single-agent JNJ-79635322 in participants with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Eligible participants must have measurable disease by central laboratory testing and an ECOG performance status of 0–2. The study will enroll patients at several U.S. cancer centers and use IMWG criteria to document progressive disease and response. The primary focus is on clinical efficacy in this heavily pretreated population, with safety and tolerability also monitored throughout treatment.

Who should consider this trial

Good fit: Adults with relapsed or refractory multiple myeloma who have received at least three prior antimyeloma regimens including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, with measurable disease and ECOG 0–2 are the intended participants.

Not a fit: Patients who have had fewer than three prior therapies, have poor performance status (ECOG >2), or have contraindications to the investigational drug (for example known hypersensitivity) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this drug could provide a new treatment option for patients with heavily pretreated relapsed or refractory multiple myeloma.

How similar studies have performed: Similar targeted agents in heavily pretreated multiple myeloma have produced variable results, and JNJ-79635322 is an investigational agent with limited published efficacy data to date.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.