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

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

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07266441
Protocol IDs
79635322MMY2001 (primary)
NCI-2025-09158
2025-521976-80-00
79635322MMY2001
Study Sponsor
Janssen Research & Development, LLC

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

  1. 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

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


Doctors:

Lizamarie Bachier
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.