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

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

  • Multiple Myeloma

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