A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
TRIlogy-4
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
2 other identifiers
interventional
400
14 countries
124
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started Feb 2026
124 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
November 21, 2025
CompletedFirst Posted
Study publicly available on registry
December 2, 2025
CompletedStudy Start
First participant enrolled
February 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2031
July 31, 2026
July 1, 2026
2.9 years
November 21, 2025
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Response
Overall response is defined as having achieved partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria, as assessed any time after first administration of study treatment, but prior to progression of disease (PD) or subsequent antimyeloma therapy.
Up to 5 years and 7 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 5 years and 7 months
Secondary Outcomes (24)
Very Good Partial Response (VGPR) or Better
Up to 5 years and 7 months
Complete Response (CR) or Better
Up to 5 years and 7 months
Duration of Response (DoR)
Up to 5 years and 7 months
Minimal Residual Disease (MRD)-negative CR
Up to 5 years and 7 months
MRD-Negative CR at 12 months
12 months
- +19 more secondary outcomes
Study Arms (2)
JNJ-79635322
EXPERIMENTALParticipants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.
Anti BCMAxCD3 Bispecific Antibody
ACTIVE COMPARATORParticipants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) 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:
- MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
- 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 antibody
- 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 IMWG criteria
- Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration
You may not qualify if:
- Active hepatitis of infectious origin
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
- Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab
- Major surgery, (example, requiring general anesthesia) within 2 weeks before 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
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, or during study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (124)
Mayo Clinic Phoenix
Phoenix, Arizona, 85054, United States
UAMS
Little Rock, Arkansas, 72205, United States
City of Hope Duarte
Duarte, California, 91010, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California San Francisco
San Francisco, California, 94122, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33901, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Moffit Cancer center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
City of Hope Chicago
Zion, Illinois, 60099, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
Mission Cancer Blood
Waukee, Iowa, 50263, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Mount Sinai Brooklyn
Brooklyn, New York, 11234, United States
NYU Winthrop
Mineola, New York, 11501, United States
Mount Sinai Chelsea
New York, New York, 10011, United States
Laura and Isaac Perlmutter Cancer Center NYU ACC
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Durham VAMC
Durham, North Carolina, 27705, United States
Oregon Health And Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
St. David's South Austin Medical Center
Austin, Texas, 78704, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Box Hill Hospital
Box Hill, 3128, Australia
Mater Misericordiae Ltd
Brisbane, 4101, Australia
Monash Medical Centre
Clayton, 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
The Alfred Hospital
Melbourne, 3004, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
Gold Coast University Hospital
Southport, 4215, Australia
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 4N1, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z4E6, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V5C2, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
University Health Network UHN Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Peking University People's Hospital
Beijing, 100044, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
First affiliated Hospital of Zhejiang University
Hangzhou, 310003, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Shanghai Fourth People s Hospital
Shanghai, 200434, China
Hospices Civils de Lyon HCL
Lyon, 69002, France
Hotel Dieu CHU de Nantes
Nantes, 44000, France
Hopital Saint Louis APHP
Paris, 75010, France
APHP
Paris, 75012, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33600, France
CHU Toulouse
Toulouse, 31300, France
CHRU de Tours
Tours, 37000, France
Marien Hospital Dusseldorf
Düsseldorf, 40479, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
Evangelismos S A
Athens, 106 76, Greece
Alexandra General Hospital of Athens
Athens, 11528, Greece
Theageneio Cancer Hospital
Thessaloniki, 546 39, Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou
Thessaloniki, 570 10, Greece
Soroka Medical Center
Beersheba, 8457108, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek MC
Jerusalem, 9103102, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Baruch Padeh MC
Ramat Poriya, 1520800, Israel
Assuta MC
Tel Aviv, 69710, Israel
A.O.U. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
Spedali Civili di Brescia
Brescia, 25123, Italy
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, 20122, Italy
Ospedale Santa Chiara AO Universitaria Pisana
Pisa, 56126, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123, Italy
Campus Bio Medico di Roma
Roma, 00128, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Humanitas Hospital
Rozzano, 20089, Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013, Italy
U.O. Ematologia Ospedale San Bortolo
Vicenza, 36100, Italy
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City, 113 8677, Japan
Chiba Cancer Center
Chiba, 260 0801, Japan
Shonan Kamakura General Hospital
Kamakura-shi, 247-8533, Japan
Kameda Medical Center
Kamogawa, 296-8602, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-0027, Japan
The Jikei University Hospital
Minato, 105-8471, Japan
Japanese Red Cross Medical Center
Shibuya City, 150-8935, Japan
Kanagawa Cancer Center
Yokohama, 241 8515, Japan
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
Erasmus MC
Rotterdam, 3015, Netherlands
Haga ziekenhuis
The Hague, 2545 AA, Netherlands
Akershus Universitetssykehus
Lorenskog, 1478, Norway
Oslo University Hospital HF Ulleval sykehus
Oslo, 0450, Norway
Stavanger University Hospital Ullandhaug
Stavanger, 4021, Norway
St. Olavs Hospital
Trondheim, 7030, Norway
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
H. Vall D'Hebron
Barcelona, 08035, Spain
Hosp. Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Univ. Virgen de Las Nieves
Granada, 18014, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Cardiff and Vale UHB - University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Ninewells Hospital & Medical School
Dundee, DD1 9SY, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
November 21, 2025
First Posted
December 2, 2025
Study Start
February 4, 2026
Primary Completion (Estimated)
December 12, 2028
Study Completion (Estimated)
September 30, 2031
Last Updated
July 31, 2026
Record last verified: 2026-07
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