A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT07266441
This study assesses the efficacy of JNJ-79635322, administered subcutaneously, in patients with Relapsed or Refractory Multiple Myeloma who have undergone at least three prior therapies. Participants must meet specific eligibility criteria related to their treatment history and health status to qualify for this clinical trial.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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:
- 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:
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| O Neal Comprehensive Cancer Center at UAB | 35294 | Birmingham | Alabama |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| City of Hope | 91010 | Duarte | California |
| City of Hope Orange County Lennar Foundation Cancer Center | 92618 | Irvine | California |
| Cancer and Blood Specialty Clinic | 90720 | Los Alamitos | California |
| University of California San Francisco | 94143 | San Francisco | California |
| Rocky Mountain Cancer Centers | 80012 | Aurora | Colorado |
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| Cancer Specialists of North Florida | 32256 | Jacksonville | Florida |
| Emory University | 30322 | Atlanta | Georgia |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.
