A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
TRIlogy-5
A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide
1 other identifier
interventional
700
18 countries
173
Brief Summary
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started May 2026
Typical duration for phase_3 multiple-myeloma
173 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedStudy Start
First participant enrolled
May 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 8, 2032
September 25, 2026
September 1, 2026
2.9 years
April 1, 2026
September 24, 2026
Conditions
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
- +16 more secondary outcomes
Study Arms (2)
Arm A: JNJ-79635322
EXPERIMENTALParticipants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).
Arm B: Teclistamab
ACTIVE COMPARATORParticipants will receive teclistamab as a SC injection until PD or intolerable toxicity.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (173)
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
UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, 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
Rush University System for Health
Chicago, Illinois, 60607, United States
Franciscan Health
Indianapolis, Indiana, 46237-8601, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Mission Cancer Blood University of Iowa Health Care
Waukee, Iowa, 50263, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
LSU Health Feist Weiller Cancer Center
Shreveport, Louisiana, 71103, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, 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
Duke University Medical Center
Durham, North Carolina, 27705, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
The Christ Hospital
Cincinnati, Ohio, 45069, United States
Dayton Physicians Network Urology
Dayton, Ohio, 45415, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Joe Arrington Cancer Research Treatment Center
Lubbock, Texas, 79410, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84102, United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
St Vincent s Hospital Sydney
Darlinghurst, 2010, Australia
Canberra Hospital
Garran, 2605, Australia
Austin Hospital
Heidelberg, 3084, Australia
Macquarie University Hospital
Macquarie University, 2109, Australia
Box Hill Hospital
Melbourne, 3128, Australia
Royal Perth Hospital
Perth, 6000, Australia
Port Macquarie Base Hospital
Port Macquarie, 2444, Australia
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
Brasília, 70200 730, Brazil
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, 81520-060, Brazil
Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
Florianópolis, 88020 210, Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Joinville, 89201-260, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050 170, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775-002, Brazil
Funfarme Sjrp
São José do Rio Preto, 15090-000, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 001, Brazil
Clinica Medica Sao Germano LTDA
São Paulo, 04537 081, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05651 901, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G-2B9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Peking Union Medical College Hospital
Beijing, 100006, China
Peking University First Hospital
Beijing, 100034, China
The First Hospital of Jilin University
Changchun, 130061, China
Beijing Chaoyang Hospital
Chaoyang District, 100020, China
Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
Sun Yat Sen University Cancer Center
Guangzhou, 510710, China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310003, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Shanghai Fourth People s Hospital
Shanghai, 200434, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tijian, 300020, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Wuhan Tongji Hospital Tongji Medical College
Wuhan, 430032, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
Fakultni nemocnice Brno
Brno, 625 00, Czechia
FN Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 52, Czechia
FN Plzen
Plzen-Lochotin, 323 00, Czechia
VFN Praha
Prague, 128 08, Czechia
CHU Amiens
Amiens, 80000, France
Hospices Civils de Lyon HCL
Lyon, 69002, France
CHRU Montpellier - Hopital Saint-Eloi
Montpellier, 34295, France
CHU Nantes - Hotel Dieu
Nantes, 44000, France
CHU Poitiers - Hopital la Miletrie
Poitiers, 86021, France
CHU Bordeaux
Talence, 33400, France
CHU Toulouse
Toulouse, 31300, France
CHRU de Tours
Tours, 37000, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20251, 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
M S Ramaiah Medical College and Hospital
Bengaluru, 560054, India
Fortis Memorial Research Institute
Gurgaon, 122002, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, 302017, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, 700014, India
Tata Medical Center
Kolkata, 700156, India
Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, 110085, 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
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
A O U Sant Orsola Malpighi
Bologna, 40138, Italy
Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
Bolzano, 39100, Italy
Ospedale San Raffaele di Milano
Milan, 20132, Italy
ASST Santi Paolo e Carlo
Milan, 20153, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
Novara, 28100, Italy
Casa di Cura La Maddalena
Palermo, 90146, Italy
Ospedale S. Spirito, Azienda Sanitaria Pescara
Pescara, 65124, Italy
Ospedale Infermi Rimini
Rimini, 47900, Italy
ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
Varese, 21100, Italy
Chiba Cancer Center
Chiba, 260-8717, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810 8563, Japan
Gunma University Hospital
Gunma, 371-0034, Japan
Shonan Kamakura General Hospital
Kamakura-shi, 247-8533, 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
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85 168, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214, Poland
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
National Cancer Center
Goyang-si, 10408, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, 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 Univ Vall D Hebron
Barcelona, 08035, Spain
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 Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Chang Kung Memorial Hospital
Kaohsiung City, 833, Taiwan
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
Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06620, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680, Turkey (Türkiye)
Ankara Etlik Sehir Hastanesi
Ankara, 6170, 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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
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
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu