Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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
(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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JNJ-79635322
Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.
  • Drug: JNJ-79635322
    JNJ-79635322 will be administered as SC injection.
Active Comparator
Anti BCMAxCD3 Bispecific Antibody
Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.
  • Drug: Teclistamab
    Teclistamab will be administered as SC injection.

Recruiting Locations

University of Kansas Cancer Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.