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

NCT07258511

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Multiple Myeloma

Interventions: JNJ-79635322, Teclistamab

Countries: United States, Australia, Canada, China, France, Germany, Greece, Israel

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 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
Locations (124)
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Duarte, California, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Denver, Colorado, United States
  • Farmington, Connecticut, United States
  • New Haven, Connecticut, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Zion, Illinois, United States
  • Iowa City, Iowa, United States
  • Waukee, Iowa, United States
  • Kansas City, Kansas, United States
  • Louisville, Kentucky, United States
  • Baltimore, Maryland, United States
  • Rochester, Minnesota, United States
  • Brooklyn, New York, United States
  • Mineola, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • + 94 more on CT.gov