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HIPAA Compliant
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Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID07258511

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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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