A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT07258511
This clinical trial evaluates the efficacy of JNJ-79635322 versus Teclistamab in patients with relapsed or refractory multiple myeloma. Both drugs are administered via subcutaneous injection. Participants must meet specific eligibility criteria related to their health status and previous treatments to enroll in the study.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility Criteria
Inclusion:
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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
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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
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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
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Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent
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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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| USC Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| University of Connecticut Health Center | 06030 | Farmington | Connecticut |
| Yale Cancer Center | 06510 | New Haven | Connecticut |
| Florida Cancer Specialists & Research Institute | 33901 | Fort Myers | Florida |
| Moffit Cancer center | 33612 | Tampa | Florida |
| Emory University | 30322 | Atlanta | Georgia |
| University of Iowa Hospital and Clinics | 52242 | Iowa City | Iowa |
| Mission Cancer Blood | 50263 | Waukee | Iowa |
| Norton Cancer Institute | 40207 | Louisville | Kentucky |
| Mount Sinai Brooklyn | 11234 | Brooklyn | New York |
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