Recruiting

Phase 3

JNJ-79635322 vs. TeclistamabA Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07518186

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-79635322

Teclistamab

Study Details

Brief summary:

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.

Conditions

Multiple Myeloma

Study ID

NCT07518186

Start date

May 31, 2026

Status verified date

Aug, 2026

Completion date

Dec 8, 2032

Anticipated

Primary completion date

Apr 29, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment

Exclusion criteria:

Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to 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
Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: JNJ-79635322

Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).

active comparator: Arm B: Teclistamab

Participants will receive teclistamab as a SC injection until PD or intolerable toxicity.

Interventions

JNJ-79635322

JNJ-79635322 will be administered as SC injection.

Teclistamab

Teclistamab will be administered as SC injection.

Primary outcome measure

Complete Response (CR) or Better [ Time Frame: Up to approximately 41 months ]
Progression-Free Survival (PFS) [ Time Frame: Up to approximately 41 months ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Alabama Oncology

Recruiting

Birmingham, Alabama, United States, 35211

Mayo Clinic 1

Recruiting

Phoenix, Arizona, United States, 85054

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Beverly Hills Cancer Center Clinical Research Advisors LLC

Recruiting

Beverly Hills, California, United States, 90211

UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

University of Connecticut Health Center

Recruiting

Farmington, Connecticut, United States, 06030

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Memorial Cancer Institute

Recruiting

Pembroke Pines, Florida, United States, 33026

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Rush University System for Health

Recruiting

Chicago, Illinois, United States, 60607

Franciscan Health

Recruiting

Indianapolis, Indiana, United States, 46237-8601

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Mission Cancer Blood University of Iowa Health Care

Recruiting

Waukee, Iowa, United States, 50263

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

LSU Health Feist Weiller Cancer Center

Recruiting

Shreveport, Louisiana, United States, 71103

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

University Of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Christus St. Vincent Regional Cancer Center

Recruiting

Santa Fe, New Mexico, United States, 87505

New York Oncology Hematology

Recruiting

Albany, New York, United States, 12208

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

NYU Langone Health Manhattan

Recruiting

New York, New York, United States, 10016

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45069

Dayton Physicians Network Urology

Recruiting

Dayton, Ohio, United States, 45415

Bon Secours Saint Francis Cancer Center

Recruiting

Greenville, South Carolina, United States, 29607

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Joe Arrington Cancer Research Treatment Center

Recruiting

Lubbock, Texas, United States, 79410

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84102

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.