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NCT07518186PHASE3Recruiting

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Janssen Research & Development, LLC

Start Date

5/31/2026

Completion Date

12/8/2032

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-79635322

DRUG

Teclistamab

Interested in This Trial?

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Conditions

Multiple Myeloma

Locations

Alabama Oncology

Birmingham, Alabama 35211

United States

Mayo Clinic 1

Phoenix, Arizona 85054

United States

Highlands Oncology Group

Springdale, Arkansas 72762

United States

Beverly Hills Cancer Center Clinical Research Advisors LLC

Beverly Hills, California 90211

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Memorial Cancer Institute

Pembroke Pines, Florida 33026

United States

Emory University

Atlanta, Georgia 30322

United States

Franciscan Health

Indianapolis, Indiana 46237-8601

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

LSU Health Feist Weiller Cancer Center

Shreveport, Louisiana 71103

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

University Of Minnesota Medical Center

Minneapolis, Minnesota 55455

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico 87505

United States

New York Oncology Hematology

Albany, New York 12208

United States

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

Mineola, New York 11501

United States

NYU Langone Health Manhattan

New York, New York 10016

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

The Christ Hospital

Cincinnati, Ohio 45069

United States

Bon Secours Saint Francis Cancer Center

Greenville, South Carolina 29607

United States

Joe Arrington Cancer Research Treatment Center

Lubbock, Texas 79410

United States

Utah Cancer Specialists

Salt Lake City, Utah 84102

United States

St Vincent s Hospital Sydney

Darlinghurst, 2010

Australia

Beijing Chaoyang Hospital

Chaoyang District, 100020

China

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tijian, 300020

China

CHU Nantes - Hotel Dieu

Nantes, 44000

France

CHU Toulouse

Toulouse, 31300

France

CHRU de Tours

Tours, 37000

France

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Asklepios Klinik Altona

Hamburg, 22763

Germany

Universitaetsklinik Tuebingen

Tübingen, 72076

Germany

Evangelismos S A

Athens, 106 76

Greece

Alexandra General Hospital of Athens

Athens, 11528

Greece

University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

Athens, 124 62

Greece

University General Hospital of Ioannina

Ioannina, 455 00Q

Greece

Bhagwan Mahaveer Cancer Hospital & Research Centre

Jaipur, 302017

India

Nil Ratan Sircar Medical College and Hospital

Kolkata, 700014

India

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004

India

Samson Assuta Ashdod University Hospital

Ashdod, 7747629

Israel

Rambam Med.Center - Hematology Institute

Haifa, 3109601

Israel

Carmel Medical Center

Haifa, 3436212

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 5266202

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, 28100

Italy

Casa di Cura La Maddalena

Palermo, 90146

Italy

National Hospital Organization Kyushu Medical Center

Fukuoka, 810 8563

Japan

Gunma University Hospital

Gunma, 371-0034

Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566

Japan

Matsuyama Red Cross Hospital

Matsuyama, 790-8524

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Sapporo City General Hospital

Sapporo, 060-8604

Japan

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550

Japan

Kanagawa Cancer Center

Yokohama, 241 8515

Japan

Pratia Onkologia Katowice

Katowice, 40 519

Poland

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, 20 090

Poland

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172

Poland

Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu

Wałbrzych, 58 309

Poland

Seoul National University Bundang Hospital

Gyeonggi-do, 13620

South Korea

Chonnam National University Hwasun Hospital

Hwasun, 58128

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

Hosp. Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. San Pedro de Alcantara

Cáceres, 10003

Spain

Hosp Reina Sofia

Córdoba, 14004

Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Clinica Univ. de Navarra

Pamplona, 31008

Spain

Hosp. Univ. Marques de Valdecilla

Santander, 39008

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

China Medical University Hospital

Taichung, 40447

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan

Ankara University Medical Faculty

Ankara, 06620

Turkey (Türkiye)

Liv Hospital Ankara

Ankara, 06680

Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, 07025

Turkey (Türkiye)

Medipol Mega University Hospital

Istanbul, 34214

Turkey (Türkiye)

Istanbul Florance Nightingale Hospital

Istanbul, 34381

Turkey (Türkiye)

Izmir Tinaztepe University Galen Hospital

Izmir, 35001

Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, 33110

Turkey (Türkiye)

Ondokuz Mayis University

Samsun, 55420

Turkey (Türkiye)