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NCT07266441
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
Conditions: Multiple Myeloma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 157
Sponsor: Janssen Research & Development, LLC
Location: O Neal Comprehensive Cancer Center at UAB Birmingham Alabama
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 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
Source: ClinicalTrials.gov (NCT07266441). StuddyBuddy aggregates publicly available trial information.