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Recruiting Phase 3 NCT07258511

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

Phase 3 – large-scale trial before approval
Conditions: Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
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.
Who can participate
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
Locations 5
Australia (1)
Box Hill Hospital
Box Hill
Brazil (1)
Hospital De Clinicas De Porto Alegre
Porto Alegre
SUSPENDED
Israel (1)
Soroka Medical Center
Beersheba
Japan (1)
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City
United States (1)
USC Norris Comprehensive Cancer Center
Los Angeles , California
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.02.2026
Completion date
30.09.2031
Registry ID
NCT07258511
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.