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Multiple MyelomaPhase 3TRIlogy-4NCT07258511

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 study testing JNJ-79635322 and Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 150 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
JNJ-79635322 and Teclistamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
150 sitesin 15 countries
Study dates
4 Feb 2026to 30 Sep 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

150 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

150 sites in 15 countries

United States42 sites, 42 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • St. David's South Austin Medical Center

    Austin, Texas, 78704

    Recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Recruiting

  • Boston University Medical Center

    Boston, Massachusetts, 02118

    Recruiting

  • Mount Sinai Brooklyn

    Brooklyn, New York, 11234

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Recruiting

  • City of Hope Duarte

    Duarte, California, 91010

    Recruiting

  • Durham VAMC

    Durham, North Carolina, 27705

    Recruiting

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

    Recruiting

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33901

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

    Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Recruiting

  • UAMS

    Little Rock, Arkansas, 72205

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

    Recruiting

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • NYU Winthrop

    Mineola, New York, 11501

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • Mount Sinai Chelsea

    New York, New York, 10011

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center NYU ACC

    New York, New York, 10016

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

    Recruiting

  • Oregon Health And Science University

    Portland, Oregon, 97239

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Recruiting

  • Texas Transplant Institute

    San Antonio, Texas, 78229

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94122

    Recruiting

  • Moffit Cancer center

    Tampa, Florida, 33612

    Recruiting

  • Mission Cancer Blood

    Waukee, Iowa, 50263

    Recruiting

  • City of Hope Chicago

    Zion, Illinois, 60099

    Recruiting

Other trials in United States

Brazil11 sites, 11 recruiting

  • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP

    Campinas, 13083-888

    Recruiting

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul, 95070 560

    Recruiting

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

    Recruiting

  • Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina

    Florianópolis, 88020 210

    Recruiting

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001

    Recruiting

  • IDOR - Regional Bahia

    Salvador, 41253-190

    Recruiting

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

    Recruiting

  • IDOR - Regional Sao Paulo

    São Paulo, 01401 002

    Recruiting

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

    Recruiting

  • Clinica Medica Sao Germano LTDA

    São Paulo, 04537 081

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900

    Recruiting

Other trials in Brazil

China11 sites, 11 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Recruiting

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610032

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

    Recruiting

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310003

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

    Recruiting

  • Shanghai Fourth People s Hospital

    Shanghai, 200434

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

  • Wuhan Tongji Hospital Tongji Medical College

    Wuhan, 430032

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710006

    Recruiting

Other trials in China

Italy11 sites, 11 recruiting

  • A.O.U. SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

    Recruiting

  • Spedali Civili di Brescia

    Brescia, 25123

    Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    Milan, 20122

    Recruiting

  • Ospedale Santa Chiara AO Universitaria Pisana

    Pisa, 56126

    Recruiting

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123

    Recruiting

  • Campus Bio Medico di Roma

    Roma, 00128

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Recruiting

  • Humanitas Hospital

    Rozzano, 20089

    Recruiting

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013

    Recruiting

  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

    Turin, 10126

    Recruiting

  • U.O. Ematologia Ospedale San Bortolo

    Vicenza, 36100

    Recruiting

Other trials in Italy

France10 sites, 10 recruiting

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59000

    Recruiting

  • Hospices Civils de Lyon HCL

    Lyon, 69002

    Recruiting

  • Centre Hospitalier Universitaire de Nancy - Hôpital Central

    Nancy, 54000

    Recruiting

  • Hotel Dieu CHU de Nantes

    Nantes, 44000

    Recruiting

  • Hopital Saint Louis APHP

    Paris, 75010

    Recruiting

  • APHP

    Paris, 75012

    Recruiting

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33600

    Recruiting

  • CHU De Poitiers

    Poitiers, 86021

    Recruiting

  • CHU Toulouse

    Toulouse, 31300

    Recruiting

  • CHRU de Tours

    Tours, 37000

    Recruiting

Other trials in France

Spain9 sites, 9 recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

    Recruiting

  • H. Vall D'Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

    Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

    Recruiting

  • Hosp de Galdakao

    Usansolo, 48960

    Recruiting

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

Australia8 sites, 8 recruiting

  • Box Hill Hospital

    Box Hill, 3128

    Recruiting

  • Mater Misericordiae Ltd

    Brisbane, 4101

    Recruiting

  • Monash Medical Centre

    Clayton, 3168

    Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

    Recruiting

  • The Alfred Hospital

    Melbourne, 3004

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, 6150

    Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

    Recruiting

  • Gold Coast University Hospital

    Southport, 4215

    Recruiting

Other trials in Australia

Israel8 sites, 8 recruiting

  • Soroka Medical Center

    Beersheba, 8457108

    Recruiting

  • Bnai Zion Medical Center

    Haifa, 31048

    Recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Carmel Medical Center

    Haifa, 34362

    Recruiting

  • Shaare Zedek MC

    Jerusalem, 9103102

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621

    Recruiting

  • Baruch Padeh MC

    Ramat Poriya, 1520800

    Recruiting

  • Assuta MC

    Tel Aviv, 69710

    Recruiting

Other trials in Israel

Japan8 sites, 8 recruiting

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō City, 113 8677

    Recruiting

  • Chiba Cancer Center

    Chiba, 260 0801

    Recruiting

  • Shonan Kamakura General Hospital

    Kamakura-shi, 247-8533

    Recruiting

  • Kameda Medical Center

    Kamogawa, 296-8602

    Recruiting

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-0027

    Recruiting

  • The Jikei University Hospital

    Minato, 105-8471

    Recruiting

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241 8515

    Recruiting

Other trials in Japan

Canada7 sites, 7 recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 4N1

    Recruiting

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

    Recruiting

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V5C2

    Recruiting

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

    Recruiting

  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

    Recruiting

  • University Health Network UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z4E6

    Recruiting

Other trials in Canada

United Kingdom7 sites, 7 recruiting

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

    Recruiting

  • Cardiff and Vale UHB - University Hospital of Wales

    Cardiff, CF14 4XW

    Recruiting

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY

    Recruiting

  • University College London Hospitals

    London, NW1 2PG

    Recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB

    Recruiting

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

    Recruiting

  • Royal Marsden Hospital

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Netherlands6 sites, 6 recruiting

  • VU Medisch Centrum

    Amsterdam, 1081 HV

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Recruiting

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM

    Recruiting

  • Radboud Umcn

    Nijmegen, 6525 GA

    Recruiting

  • Erasmus MC

    Rotterdam, 3015

    Recruiting

  • Haga ziekenhuis

    The Hague, 2545 AA

    Recruiting

Other trials in Netherlands

Germany4 sites, 4 recruiting

  • Marien Hospital Dusseldorf

    Düsseldorf, 40479

    Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

    Recruiting

  • Universitatsklinikum Jena

    Jena, 07747

    Recruiting

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

    Recruiting

Other trials in Germany

Greece4 sites, 4 recruiting

  • Evangelismos S A

    Athens, 106 76

    Recruiting

  • Alexandra General Hospital of Athens

    Athens, 11528

    Recruiting

  • Theageneio Cancer Hospital

    Thessaloniki, 546 39

    Recruiting

  • Geniko Nosokomeio Thessalonikis George Papanikolaou

    Thessaloniki, 570 10

    Recruiting

Other trials in Greece

Norway4 sites, 4 recruiting

  • Akershus Universitetssykehus

    Lorenskog, 1478

    Recruiting

  • Oslo University Hospital HF Ulleval sykehus

    Oslo, 0450

    Recruiting

  • Stavanger University Hospital Ullandhaug

    Stavanger, 4021

    Recruiting

  • St. Olavs Hospital

    Trondheim, 7030

    Recruiting

Other trials in Norway

About this study

Official title: 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

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.

Being tested
JNJ-79635322, Teclistamab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-79635322Drug

    JNJ-79635322 will be administered as SC injection.

  • TeclistamabDrug

    Teclistamab will be administered as SC injection.

Study groups in NCT07258511
Study groupRoleWhat they receive
JNJ-79635322ExperimentalParticipants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.
Receives: Drug: JNJ-79635322
Anti BCMAxCD3 Bispecific AntibodyActive comparatorParticipants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.
Receives: Drug: Teclistamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 5 years and 7 months

  2. 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.

    Measured: Up to 5 years and 7 months

Secondary outcomes (24)

  1. Very Good Partial Response (VGPR) or Better

    VGPR or better is defined as achieving VGPR, complete response (CR), or stringent complete response (sCR) in accordance with the IMWG criteria during or after the study treatment but prior to subsequent antimyeloma therapy.

    Measured: Up to 5 years and 7 months

  2. Complete Response (CR) or Better

    CR or better is defined as achieving CR or sCR in accordance with the IMWG criteria during or after the study treatment but prior to subsequent antimyeloma therapy.

    Measured: Up to 5 years and 7 months

  3. Duration of Response (DoR)

    DoR is defined as the time interval between the date of initial documentation of a response (partial response [PR] or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first.

    Measured: Up to 5 years and 7 months

  4. Minimal Residual Disease (MRD)-negative CR

    MRD-negative CR is defined as the participants who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after the date of randomization and prior to PD or subsequent antimyeloma therapy. Additionally, participants must achieve CR or better, according to IMWG response criteria at any time from the date of randomization and within 3 months after achieving MRD negative status, prior to PD or subsequent antimyeloma therapy.

    Measured: Up to 5 years and 7 months

  5. MRD-Negative CR at 12 months

    MRD-negative CR at 12 months is defined as the participants who achieve MRD-negative status at the analysis time window of 12 months (+/-3 months) from the date of randomization, as determined by NGF prior to PD or subsequent anti-myeloma therapy. Additionally, participants must also achieve CR or better, according to IMWG criteria at any time from the date of randomization up to and including 12 months (+/-3 months), prior to PD or subsequent antimyeloma therapy.

    Measured: 12 months

  6. Sustained MRD-negative CR

    Sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGF, for at least 12 months without any examination showing MRD-positive status and prior to PD or subsequent anti-myeloma therapy.

    Measured: Up to 5 years and 7 months

  7. Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)

    PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Those who are alive and for whom a second disease progression has not been observed are censored at the last date of follow-up.

    Measured: Up to 5 years and 7 months

  8. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.

    Measured: Up to 5 years and 7 months

  9. Time to Subsequent Anti-Myeloma Therapy

    Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.

    Measured: Up to 5 years and 7 months

  10. Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, to Grade 5= death related to adverse event.

    Measured: Up to 5 years and 7 months

  11. Number of Participants with Abnormalities in Clinical Laboratories Results

    Number of participants with abnormalities in clinical laboratories results (serum chemistry and hematology) will be reported.

    Measured: Up to 5 years and 7 months

  12. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score

    Change from baseline in symptoms, functioning, and health-related quality of life (HRQoL) as assessed by multiple myeloma symptom and impact questionnaire (MySIm-Q) score will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM.

    Measured: Baseline up to 5 years and 7 months

  13. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Score

    Change from baseline in symptoms, functioning, and HRQoL as assessed by european organization for research and treatment of cancer quality of life questionnaire core 30 (EORTC-QLQ-C30) score will be reported.

    Measured: Baseline up to 5 years and 7 months

  14. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score

    The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.

    Measured: Baseline up to 5 years and 7 months

  15. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score

    Time to worsening in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported. The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.

    Measured: Up to 5 years and 7 months

  16. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score

    Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

    Measured: Up to 5 years and 7 months

  17. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score

    The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.

    Measured: Up to 5 years and 7 months

  18. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score

    The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. It is included to be complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale.

    Measured: Up to 5 years and 7 months

  19. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score

    Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

    Measured: Up to 5 years and 7 months

  20. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score

    The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.

    Measured: Up to 5 years and 7 months

  21. Percentage of Participants With Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 (EORTC IL46)

    Percentage of participants with side effects burden on the EORTC IL46 will be reported. The EORTC IL46 measures the global impression of burden due to treatment-related symptoms.

    Measured: Up to 5 years and 7 months

  22. Serum Concentrations for JNJ-79635322

    Serum concentrations of JNJ-79635322 will be reported.

    Measured: Up to 5 years and 7 months

  23. Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322

    Serum samples will be analyzed for the detection of ADA to JNJ-79635322 using a validated assay method.

    Measured: Up to 5 years and 7 months

  24. Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322

    Number of participants who are ADA-positive will be assessed for the presence of NAbs.

    Measured: Up to 5 years and 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start4 Feb 2026
  3. Primary completion12 Dec 2028 (estimated)
  4. Study completion30 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258511
Sponsor's protocol ID
79635322MMY3001
Other IDs
2025-522007-18-00, 2025
Acronym
TRIlogy-4
Status last verified
Sep 2026
First submitted
21 Nov 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JNJ-79635322 and Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 150 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Brazil, China, Italy, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response (time frame: Up to 5 years and 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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