A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
Purpose
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
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 antibody
- Documented evidence of progressive disease (PD) or failure to achieve a response
(that is partial response [PR] or better) to the last line of therapy based on
investigator's determination of response by 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 of 0 to 2 at
screening and immediately before the start of study treatment administration
Exclusion:
- Active hepatitis of infectious origin
- Known active or prior central nervous system (CNS) involvement or exhibits clinical
signs of meningeal involvement of MM
- Suspected or known allergies, hypersensitivity, or intolerance to the excipients of
JNJ-79635322 and Teclistamab
- Major surgery , (example, requiring general anesthesia) within 2 weeks before first
dose, or will not have fully recovered from surgery, or has surgery planned during
the time the participant is expected to participate in the study
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the
first dose of study treatment, during, or within 90 days after the last dose of
study treatment
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental JNJ-79635322 |
Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity. |
|
|
Active Comparator Anti BCMAxCD3 Bispecific Antibody |
Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity. |
|
Recruiting Locations
Los Angeles, California 90033
Denver, Colorado 80218
Farmington, Connecticut 06030
New Haven, Connecticut 06510
Fort Myers, Florida 33901
Tampa, Florida 33612
Atlanta, Georgia 30322
Iowa City, Iowa 52242
Waukee, Iowa 50263
Louisville, Kentucky 40207
Brooklyn, New York 11234
Mineola, New York 11501
New York, New York 10011
New York, New York 10016
New York, New York 10029
New York, New York 10065
Durham, North Carolina 27705
Portland, Oregon 97239
Philadelphia, Pennsylvania 19107
Nashville, Tennessee 37203
Austin, Texas 78704
Dallas, Texas 75246
Salt Lake City, Utah 84112
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC