RecruitingPhase 3NCT07258511

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 Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

Sponsor

Janssen Research & Development, LLC

Enrollment

400 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for multiple myeloma (a blood cancer affecting plasma cells) in patients whose cancer has come back or stopped responding after at least 3 prior treatments: a new drug called JNJ-79635322 versus an already-approved bispecific antibody therapy (teclistamab). **You may be eligible if...** - You have confirmed multiple myeloma with measurable disease - You have received at least 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody - Your cancer is progressing or did not respond adequately to your most recent treatment - You have a reasonable performance status (ECOG 0–2) **You may NOT be eligible if...** - You have active hepatitis or other serious infections - Your cancer has spread to the brain or spinal fluid - You have had major surgery within 2 weeks - You have received a live vaccine recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-79635322

JNJ-79635322 will be administered as SC injection.

DRUGTeclistamab

Teclistamab will be administered as SC injection.

Locations(39)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Mission Cancer Blood

Waukee, Iowa, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Mount Sinai Brooklyn

Brooklyn, New York, United States

Mount Sinai Chelsea

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Durham VAMC

Durham, North Carolina, United States

Oregon Health And Science University

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Box Hill Hospital

Box Hill, Australia

Mater Misericordiae Ltd

Brisbane, Australia

Monash Medical Centre

Clayton, Australia

St Vincents Hospital Melbourne

Fitzroy, Australia

The Alfred Hospital

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

Gold Coast University Hospital

Southport, Australia

Hospital De Clinicas De Porto Alegre

Porto Alegre, Brazil

Soroka Medical Center

Beersheba, Israel

Bnai Zion Medical Center

Haifa, Israel

Rambam Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek MC

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Baruch Padeh MC

Ramat Poriya, Israel

Assuta MC

Tel Aviv, Israel

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, Japan

Chiba Cancer Center

Chiba, Japan

Shonan Kamakura General Hospital

Kamakura-shi, Japan

Kameda Medical Center

Kamogawa, Japan

Yamanashi Prefectural Central Hospital

Kofu, Japan

The Jikei University Hospital

Minato, Japan

Japanese Red Cross Medical Center

Shibuya City, Japan

Kanagawa Cancer Center

Yokohama, Japan

View Full Details on ClinicalTrials.gov

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