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NCT07266441PHASE2Recruiting

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

Janssen Research & Development, LLC

Start Date

2/8/2026

Completion Date

12/12/2028

Summary

The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.

Eligibility Criteria

Age Range: 18 years to No maximum

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 monoclonal antibody (mAb) * 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 the 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 (PS) of 0 to 2 at screening and immediately before the start of study treatment administration Exclusion: * Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322 * Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase * Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM * Participant has leptomeningeal disease * Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment

Interventions

DRUG

JNJ-79635322

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Conditions

Multiple Myeloma

Locations

O Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama 35294

United States

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

City of Hope

Duarte, California 91010

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

University of California San Francisco

San Francisco, California 94143

United States

Rocky Mountain Cancer Centers

Aurora, Colorado 80012

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Cancer Specialists of North Florida

Jacksonville, Florida 32256

United States

Emory University

Atlanta, Georgia 30322

United States

Northside Hospital Cancer Institute

Atlanta, Georgia 30342

United States

Cancer Care Specialists of Central Illinois

O'Fallon, Illinois 62269

United States

University of Iowa

Iowa City, Iowa 52242

United States

Mission Cancer Blood

Waukee, Iowa 50263

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Rutgers Cancer Institute

New Brunswick, New Jersey 08901

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Cleveland Clinic Foundtation

Cleveland, Ohio 44195

United States

Oncology Associates of Oregon PC Willamette Valley Cancer Institute

Eugene, Oregon 97401

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology, PLLC

Nashville, Tennessee 37203

United States

Texas Oncology

Austin, Texas 78705

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Oncology Consultants Texas

Houston, Texas 77030

United States

Texas Oncology - Northeast

Tyler, Texas 75702

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

NorthWest Medical Specialties, PLLC

Tacoma, Washington 98405

United States

Peking Union Medical College Hospital

Beijing, 100006

China

Beijing Chaoyang Hospital

Chaoyang District, 100020

China

Sun Yat Sen University Cancer Center

Guangzhou, 510700

China

Shanghai Fourth People s Hospital

Shanghai, 200434

China

Ha'Emek Medical Center

Afula, 1834111

Israel

Samson Assuta Ashdod University Hospital

Ashdod, 7747629

Israel

Hillel Yaffe Medical Center

Hadera, 3820302

Israel

Hadassah Medical Center

Jerusalem, 9112000

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127

Italy

Policlinico Sant'Orsola Malpighi

Bologna, 40138

Italy

Azienda Ospedaliera S Croce e Carle Cuneo

Cuneo, 12100

Italy

Azienda Ospedaliero Universitaria Careggi

Florence, 50134

Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, 90127

Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, 27100

Italy

Presidio Ospedaliero Pescara

Pescara, 65124

Italy

AOU Policlinico Umberto I

Roma, 00161

Italy

Centro Ricerche Cliniche di Verona S r l

Verona, 37134

Italy

National Hospital Organization Shibukawa Medical Center

Gunma, 377-0280

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

Brzozów, 36 200

Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, 25 734

Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, 30 688

Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, 93 513

Poland

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

Lublin, 20 081

Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569

Poland

Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

Torun, 87 100

Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, 50 367

Poland

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591

South Korea

Ankara University Medical Faculty

Ankara, 06590

Turkey (Türkiye)

Liv Hospital Ankara

Ankara, 06680

Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, 07025

Turkey (Türkiye)

Medipol University Hospital

Istanbul, 34214

Turkey (Türkiye)

Istanbul Florance Nightingale Hospital

Istanbul, 34381

Turkey (Türkiye)

Sakarya Üniversitesi Tıp Fakültesi Hastanesi

Sakarya, 54050

Turkey (Türkiye)