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

NCT07518186 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 79635322MMY3002
• Study Type: interventional
• Target: 700
• Locations: 15 countries
• Sites: 88

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Complete Response (CR) or Better

  CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.

  Up to approximately 41 months

• Progression-Free Survival (PFS)

  PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.

  Up to approximately 41 months

Secondary Outcomes (21)

• Overall Response Rate (ORR)

  Up to approximately 41 months

• Very Good Partial Response (VGPR) or Better

  Up to approximately 41 months

• Duration of Response (DoR)

  Up to approximately 41 months

• Minimal Residual Disease (MRD)-negative CR

  Up to approximately 41 months

• MRD-negative CR at 1 Year

  At 1 Year

Study Arms (2)

Arm A: JNJ-79635322

EXPERIMENTAL

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

Drug: JNJ-79635322

Arm B: Teclistamab

ACTIVE COMPARATOR

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

Drug: Teclistamab

Interventions

Teclistamab DRUG

Teclistamab will be administered as SC injection.

Arm B: Teclistamab

JNJ-79635322 DRUG

JNJ-79635322 will be administered as SC injection.

Arm A: JNJ-79635322

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (88)

Alabama Oncology

Birmingham, Alabama, 35211, United States

RECRUITING

Mayo Clinic 1

Phoenix, Arizona, 85054, United States

RECRUITING

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

RECRUITING

Beverly Hills Cancer Center Clinical Research Advisors LLC

Beverly Hills, California, 90211, United States

RECRUITING

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Memorial Cancer Institute

Pembroke Pines, Florida, 33026, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Franciscan Health

Indianapolis, Indiana, 46237-8601, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

RECRUITING

LSU Health Feist Weiller Cancer Center

Shreveport, Louisiana, 71103, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

University Of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, 87505, United States

RECRUITING

New York Oncology Hematology

Albany, New York, 12208, United States

RECRUITING

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

Mineola, New York, 11501, United States

RECRUITING

NYU Langone Health Manhattan

New York, New York, 10016, United States

RECRUITING

New York Cancer and Blood Specialists

Shirley, New York, 11967, United States

RECRUITING

Gabrail Cancer Center

Canton, Ohio, 44718, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45069, United States

RECRUITING

Bon Secours Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

RECRUITING

Joe Arrington Cancer Research Treatment Center

Lubbock, Texas, 79410, United States

RECRUITING

Utah Cancer Specialists

Salt Lake City, Utah, 84102, United States

RECRUITING

St Vincent s Hospital Sydney

Darlinghurst, 2010, Australia

RECRUITING

Beijing Chaoyang Hospital

Chaoyang District, 100020, China

RECRUITING

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

Tijian, 300020, China

RECRUITING

CHU Nantes - Hotel Dieu

Nantes, 44000, France

RECRUITING

CHU Toulouse

Toulouse, 31300, France

RECRUITING

CHRU de Tours

Tours, 37000, France

RECRUITING

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, 22763, Germany

RECRUITING

Universitaetsklinik Tuebingen

Tübingen, 72076, Germany

RECRUITING

Evangelismos S A

Athens, 106 76, Greece

RECRUITING

Alexandra General Hospital of Athens

Athens, 11528, Greece

RECRUITING

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

Athens, 124 62, Greece

RECRUITING

University General Hospital of Ioannina

Ioannina, 455 00Q, Greece

RECRUITING

Bhagwan Mahaveer Cancer Hospital & Research Centre

Jaipur, 302017, India

RECRUITING

Nil Ratan Sircar Medical College and Hospital

Kolkata, 700014, India

RECRUITING

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004, India

RECRUITING

Samson Assuta Ashdod University Hospital

Ashdod, 7747629, Israel

RECRUITING

Rambam Med.Center - Hematology Institute

Haifa, 3109601, Israel

RECRUITING

Carmel Medical Center

Haifa, 3436212, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, 5266202, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, 28100, Italy

RECRUITING

Casa di Cura La Maddalena

Palermo, 90146, Italy

RECRUITING

National Hospital Organization Kyushu Medical Center

Fukuoka, 810 8563, Japan

RECRUITING

Gunma University Hospital

Gunma, 371-0034, Japan

RECRUITING

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

RECRUITING

Matsuyama Red Cross Hospital

Matsuyama, 790-8524, Japan

RECRUITING

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

RECRUITING

Sapporo City General Hospital

Sapporo, 060-8604, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, 241 8515, Japan

RECRUITING

Pratia Onkologia Katowice

Katowice, 40 519, Poland

RECRUITING

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, 20 090, Poland

RECRUITING

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

RECRUITING

Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu

Wałbrzych, 58 309, Poland

RECRUITING

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

RECRUITING

Hosp. Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hosp. San Pedro de Alcantara

Cáceres, 10003, Spain

RECRUITING

Hosp Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Clinica Univ. de Navarra

Pamplona, 31008, Spain

RECRUITING

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

RECRUITING

Hosp. Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Ankara University Medical Faculty

Ankara, 06620, Turkey (Türkiye)

RECRUITING

Liv Hospital Ankara

Ankara, 06680, Turkey (Türkiye)

RECRUITING

Memorial Antalya Hospital

Antalya, 07025, Turkey (Türkiye)

RECRUITING

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

Istanbul Florance Nightingale Hospital

Istanbul, 34381, Turkey (Türkiye)

RECRUITING

Izmir Tinaztepe University Galen Hospital

Izmir, 35001, Turkey (Türkiye)

RECRUITING

Mersin University Medical Faculty

Mersin, 33110, Turkey (Türkiye)

RECRUITING

Ondokuz Mayis University

Samsun, 55420, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): April 29, 2029
• Study Completion (Estimated): December 8, 2032
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

IN (3); CN (2); PL (4); ES (8); DE (3); GR (4); IT (2); KR (5); FR (3); TW (5); US (26); IL (6); TU (8); AU (1); JP (8)