A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
Purpose
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.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental JNJ-79635322 |
Participants will receive JNJ-79635322 as an injection under the skin. |
|
Recruiting Locations
Duarte, California 91010
Irvine, California 92618
Los Alamitos, California 90720
Jacksonville, Florida 32256
Atlanta, Georgia 30322
Atlanta, Georgia 30342
O'Fallon, Illinois 62269
Iowa City, Iowa 52242
Waukee, Iowa 50263
New Brunswick, New Jersey 08901
New York, New York 10065
Cleveland, Ohio 44195
Houston, Texas 77030
Houston, Texas 77030
Tacoma, Washington 98405
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC