Actively Recruiting
A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
400
Participants Needed
65
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating JNJ-79635322 compared with an anti-B-cell maturation antigen BCMAxCD3 bispecific antibody in people with relapsed or refractory multiple myeloma who have received at least three prior treatments including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. This phase 3 randomized study aims to understand how well these treatments work in this patient population by comparing responses and progression outcomes over time. Participants will receive either JNJ-79635322 or teclistamab, both given as subcutaneous injections. Treatment continues until the disease progresses or side effects become intolerable. The study involves two treatment arms, one for each drug, and participants are randomly assigned to one of these groups. Both treatments are administered regularly as injections under the skin. During the study, participants will undergo various assessments including response evaluations, progression-free survival checks, and monitoring of side effects for up to five years and four months. Researchers will also track quality of life, symptom changes, and laboratory results. The study includes long-term follow-up on treatment effects, survival, and time to next therapy, with careful recording of any adverse events and immune responses to the drugs.
CONDITIONS
Brief Title
A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of multiple myeloma according to international myeloma working group (IMWG) criteria
- 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-CD38 antibody
- Documented evidence of progressive disease or failure to achieve a response to the last line of therapy
- Discontinued concurrent use of any other anticancer treatment or investigational agent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening and before starting study treatment
You will not qualify if you...
- Active hepatitis of infectious origin
- Known active or prior central nervous system (CNS) involvement or meningeal involvement of multiple myeloma
- Known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322 or teclistamab
- Major surgery requiring general anesthesia within 2 weeks before first dose or incomplete recovery from surgery
- Received or plans to receive any live, attenuated vaccine within 4 weeks before first dose, during, or within 90 days after last dose of study treatment
Research Team
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Study Contact
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