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 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

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

Mayo Clinic Phoenix
Phoenix, Arizona 85054

UAMS
Little Rock, Arkansas 72205

City of Hope Duarte
Duarte, California 91010

City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California 92618

USC Norris Comprehensive Cancer Center
Los Angeles, California 90033

University of California San Francisco
San Francisco, California 94122

Colorado Blood Cancer Institute
Denver, Colorado 80218

University of Connecticut Health Center
Farmington, Connecticut 06030

Yale Cancer Center
New Haven, Connecticut 06510

Florida Cancer Specialists & Research Institute
Fort Myers, Florida 33901

Mayo Clinic Jacksonville
Jacksonville, Florida 32224

Moffit Cancer center
Tampa, Florida 33612

Emory University
Atlanta, Georgia 30322

City of Hope Chicago
Zion, Illinois 60099

University of Iowa Hospital and Clinics
Iowa City, Iowa 52242

Mission Cancer Blood
Waukee, Iowa 50263

University of Kansas Cancer Center
Kansas City, Kansas 66160

Norton Cancer Institute
Louisville, Kentucky 40207

University of Maryland School of Medicine
Baltimore, Maryland 21201

Mayo Clinic Rochester
Rochester, Minnesota 55905

Mount Sinai Brooklyn
Brooklyn, New York 11234

NYU Winthrop
Mineola, New York 11501

Mount Sinai Chelsea
New York, New York 10011

Laura and Isaac Perlmutter Cancer Center NYU ACC
New York, New York 10016

Icahn School of Medicine at Mount Sinai
New York, New York 10029

Memorial Sloan Kettering Cancer Center
New York, New York 10065

University of North Carolina
Chapel Hill, North Carolina 27514

Durham VAMC
Durham, North Carolina 27705

Oregon Health And Science University
Portland, Oregon 97239

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107

SCRI Oncology Partners
Nashville, Tennessee 37203

St. David's South Austin Medical Center
Austin, Texas 78704

Baylor University Medical Center
Dallas, Texas 75246

UT Southwestern Medical Center
Dallas, Texas 75390

Texas Transplant Institute
San Antonio, Texas 78229

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Medical College Of Wisconsin
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT07258511
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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