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
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC