Compares JNJ-79635322 with teclistamab in adults with relapsed or hard-to-treat multiple myeloma
Compares JNJ-79635322 with another antibody therapy in adults with relapsed multiple myeloma.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Campinas, Caxias do Sul, Curitiba, Florianópolis, Rio de Janeiro, Salvador, São José do Rio Preto, and São Paulo, BrazilSee the 11 sites
- Phase
- Phase 3
Where in Brazil
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMPCampinas, BrazilTaking people
- Fundacao Universidade de Caxias Do SulCaxias do Sul, BrazilTaking people
- Hospital Erasto Gaertner - Liga Paranaense de Combate ao CâncerCuritiba, BrazilTaking people
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa CatarinaFlorianópolis, BrazilTaking people
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)Rio de Janeiro, BrazilTaking people
- IDOR - Regional BahiaSalvador, BrazilTaking people
- Funfarme SjrpSão José do Rio Preto, BrazilTaking people
- Clinica Medica Sao Germano LTDASão Paulo, BrazilTaking people
- Fundacao Antonio Prudente A C Camargo Cancer CenterSão Paulo, BrazilTaking people
- IDOR - Regional Sao PauloSão Paulo, BrazilTaking people
- Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07258511EU 2025-522007-18-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion:; 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; 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 to the last line of therapy based on investigator's determination of response by IMWG criteria; Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better; 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, or during study treatment.