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AzTrials

Multiple MyelomaPhase 3TRIlogy-5NCT07518186

A Study Comparing JNJ-79635322 and Teclistamab 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 173 sites in 18 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 teclistamab. 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
700 participants
Where
173 sitesin 18 countries
Study dates
31 May 2026to 8 Dec 2032
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: 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

Who cannot join

  • 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

Trial locations and contacts

173 sites in 18 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

173 sites in 18 countries

United States41 sites, 41 recruiting

  • New York Oncology Hematology

    Albany, New York, 12208

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Recruiting

  • Beverly Hills Cancer Center Clinical Research Advisors LLC

    Beverly Hills, California, 90211

    Recruiting

  • Alabama Oncology

    Birmingham, Alabama, 35211

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Recruiting

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Recruiting

  • Rush University System for Health

    Chicago, Illinois, 60607

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45069

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Recruiting

  • Dayton Physicians Network Urology

    Dayton, Ohio, 45415

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27705

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Recruiting

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

    Recruiting

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

    Recruiting

  • Bon Secours Saint Francis Cancer Center

    Greenville, South Carolina, 29607

    Recruiting

  • Franciscan Health

    Indianapolis, Indiana, 46237-8601

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Recruiting

  • UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

    Recruiting

  • Joe Arrington Cancer Research Treatment Center

    Lubbock, Texas, 79410

    Recruiting

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

    Mineola, New York, 11501

    Recruiting

  • University Of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

    Recruiting

  • NYU Langone Health Manhattan

    New York, New York, 10016

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Recruiting

  • University of California Irvine Medical Center

    Orange, California, 92868

    Recruiting

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33026

    Recruiting

  • Mayo Clinic 1

    Phoenix, Arizona, 85054

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84102

    Recruiting

  • Christus St. Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505

    Recruiting

  • New York Cancer and Blood Specialists

    Shirley, New York, 11967

    Recruiting

  • LSU Health Feist Weiller Cancer Center

    Shreveport, Louisiana, 71103

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Recruiting

  • NorthWest Medical Specialties, PLLC

    Tacoma, Washington, 98405

    Recruiting

  • Mission Cancer Blood University of Iowa Health Care

    Waukee, Iowa, 50263

    Recruiting

Other trials in United States

China16 sites, 16 recruiting

  • Peking Union Medical College Hospital

    Beijing, 100006

    Recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • The First Hospital of Jilin University

    Changchun, 130061

    Recruiting

  • Beijing Chaoyang Hospital

    Chaoyang District, 100020

    Recruiting

  • Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital

    Chengdu, 610072

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510710

    Recruiting

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003

    Recruiting

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

    Recruiting

  • Shanghai Fourth People s Hospital

    Shanghai, 200434

    Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

    Recruiting

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

    Tijian, 300020

    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, 710004

    Recruiting

Other trials in China

Spain11 sites, 11 recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hosp. San Pedro de Alcantara

    Cáceres, 10003

    Recruiting

  • Hosp Reina Sofia

    Córdoba, 14004

    Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008

    Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

    Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

    Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013

    Recruiting

Other trials in Spain

Turkey (Türkiye)11 sites, 11 recruiting

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010

    Recruiting

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Ankara University Medical Faculty

    Ankara, 06620

    Recruiting

  • Liv Hospital Ankara

    Ankara, 06680

    Recruiting

  • Ankara Etlik Sehir Hastanesi

    Ankara, 6170

    Recruiting

  • Memorial Antalya Hospital

    Antalya, 07025

    Recruiting

  • Medipol Mega University Hospital

    Istanbul, 34214

    Recruiting

  • Istanbul Florance Nightingale Hospital

    Istanbul, 34381

    Recruiting

  • Izmir Tinaztepe University Galen Hospital

    Izmir, 35001

    Recruiting

  • Mersin University Medical Faculty

    Mersin, 33110

    Recruiting

  • Ondokuz Mayis University

    Samsun, 55420

    Recruiting

Other trials in Turkey (Türkiye)

Brazil10 sites, 10 recruiting

  • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

    Brasília, 70200 730

    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 Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

    Joinville, 89201-260

    Recruiting

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050 170

    Recruiting

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

    Rio de Janeiro, 22775-002

    Recruiting

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

    Recruiting

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 001

    Recruiting

  • Clinica Medica Sao Germano LTDA

    São Paulo, 04537 081

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05651 901

    Recruiting

Other trials in Brazil

Italy10 sites, 10 recruiting

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124

    Recruiting

  • A O U Sant Orsola Malpighi

    Bologna, 40138

    Recruiting

  • Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano

    Bolzano, 39100

    Recruiting

  • Ospedale San Raffaele di Milano

    Milan, 20132

    Recruiting

  • ASST Santi Paolo e Carlo

    Milan, 20153

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

    Novara, 28100

    Recruiting

  • Casa di Cura La Maddalena

    Palermo, 90146

    Recruiting

  • Ospedale S. Spirito, Azienda Sanitaria Pescara

    Pescara, 65124

    Recruiting

  • Ospedale Infermi Rimini

    Rimini, 47900

    Recruiting

  • ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi

    Varese, 21100

    Recruiting

Other trials in Italy

Japan10 sites, 10 recruiting

  • Chiba Cancer Center

    Chiba, 260-8717

    Recruiting

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563

    Recruiting

  • Gunma University Hospital

    Gunma, 371-0034

    Recruiting

  • Shonan Kamakura General Hospital

    Kamakura-shi, 247-8533

    Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

    Recruiting

  • Matsuyama Red Cross Hospital

    Matsuyama, 790-8524

    Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

    Recruiting

  • Sapporo City General Hospital

    Sapporo, 060-8604

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241 8515

    Recruiting

Other trials in Japan

France8 sites, 8 recruiting

  • CHU Amiens

    Amiens, 80000

    Recruiting

  • Hospices Civils de Lyon HCL

    Lyon, 69002

    Recruiting

  • CHRU Montpellier - Hopital Saint-Eloi

    Montpellier, 34295

    Recruiting

  • CHU Nantes - Hotel Dieu

    Nantes, 44000

    Recruiting

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021

    Recruiting

  • CHU Bordeaux

    Talence, 33400

    Recruiting

  • CHU Toulouse

    Toulouse, 31300

    Recruiting

  • CHRU de Tours

    Tours, 37000

    Recruiting

Other trials in France

Australia7 sites, 7 recruiting

  • St Vincent s Hospital Sydney

    Darlinghurst, 2010

    Recruiting

  • Canberra Hospital

    Garran, 2605

    Recruiting

  • Austin Hospital

    Heidelberg, 3084

    Recruiting

  • Macquarie University Hospital

    Macquarie University, 2109

    Recruiting

  • Box Hill Hospital

    Melbourne, 3128

    Recruiting

  • Royal Perth Hospital

    Perth, 6000

    Recruiting

  • Port Macquarie Base Hospital

    Port Macquarie, 2444

    Recruiting

Other trials in Australia

India7 sites, 7 recruiting

  • M S Ramaiah Medical College and Hospital

    Bengaluru, 560054

    Recruiting

  • Fortis Memorial Research Institute

    Gūrgaon, 122002

    Recruiting

  • Bhagwan Mahaveer Cancer Hospital & Research Centre

    Jaipur, 302017

    Recruiting

  • Nil Ratan Sircar Medical College and Hospital

    Kolkata, 700014

    Recruiting

  • Tata Medical Center

    Kolkata, 700156

    Recruiting

  • Rajiv Gandhi Cancer Institute and Research Centre

    New Delhi, 110085

    Recruiting

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004

    Recruiting

Other trials in India

South Korea7 sites, 7 recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

    Recruiting

Other trials in South Korea

Israel6 sites, 6 recruiting

  • Samson Assuta Ashdod University Hospital

    Ashdod, 7747629

    Recruiting

  • Rambam Med.Center - Hematology Institute

    Haifa, 3109601

    Recruiting

  • Carmel Medical Center

    Haifa, 3436212

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 5266202

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Poland6 sites, 6 recruiting

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85 168

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

    Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40 519

    Recruiting

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090

    Recruiting

  • Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu

    Wałbrzych, 58 309

    Recruiting

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172

    Recruiting

Other trials in Poland

Taiwan6 sites, 6 recruiting

  • Chang Kung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

  • China Medical University Hospital

    Taichung, 40447

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 70403

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112

    Recruiting

Other trials in Taiwan

Czechia5 sites, 5 recruiting

  • Fakultni nemocnice Brno

    Brno, 625 00

    Recruiting

  • FN Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52

    Recruiting

  • FN Plzen

    Plzen-Lochotin, 323 00

    Recruiting

  • VFN Praha

    Prague, 128 08

    Recruiting

Other trials in Czechia

Canada4 sites, 4 recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G-2B9

    Recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Germany4 sites, 4 recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Recruiting

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20251

    Recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763

    Recruiting

  • Universitaetsklinik Tuebingen

    Tübingen, 72076

    Recruiting

Other trials in Germany

Greece4 sites, 4 recruiting

  • Evangelismos S A

    Athens, 106 76

    Recruiting

  • Alexandra General Hospital of Athens

    Athens, 11528

    Recruiting

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

    Athens, 124 62

    Recruiting

  • University General Hospital of Ioannina

    Ioannina, 455 00Q

    Recruiting

Other trials in Greece

About this study

Official title: 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

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

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 NCT07518186
Study groupRoleWhat they receive
Arm A: JNJ-79635322ExperimentalParticipants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).
Receives: Drug: JNJ-79635322
Arm B: TeclistamabActive comparatorParticipants will receive teclistamab 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. 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.

    Measured: Up to approximately 41 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 approximately 41 months

Secondary outcomes (21)

  1. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.

    Measured: Up to approximately 41 months

  2. Very Good Partial Response (VGPR) or Better

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

    Measured: Up to approximately 41 months

  3. Duration of Response (DoR)

    DoR is defined as the time interval between the date of initial documentation of a 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 approximately 41 months

  4. Minimal Residual Disease (MRD)-negative CR

    MRD-negative CR is defined as the percentage of participants with CR or better who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after randomization and prior to PD or subsequent antimyeloma therapy.

    Measured: Up to approximately 41 months

  5. MRD-negative CR at 1 Year

    MRD-negative CR at 1 year is defined as the percentage of participants who achieve MRD-negative status at 12 months as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria.

    Measured: At 1 Year

  6. MRD-negative CR at 5 Years

    MRD-negative CR at 5 years is defined as the percentage of participants who achieve MRD-negative status at 5 years as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria.

    Measured: At 5 Years

  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 approximately 41 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 approximately 41 months

  9. Time To Next Line of Therapy (TTNT)

    TTNT 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 approximately 41 months

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

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. 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 will be considered treatment-related regardless of the start date of the event. 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, Grade 5= death related to adverse event.

    Measured: Up to approximately 41 months

  11. Number of Participants with Abnormalities in Laboratory Parameters

    Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported.

    Measured: Up to approximately 41 months

  12. Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores

    Change from baseline in HRQoL, symptoms and functioning as assessed by 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: From Baseline up to approximately 41 months

  13. Change from Baseline in HRQoL, Symptoms and Functioning Using the European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Scores

    Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

    Measured: From Baseline up to approximately 41 months

  14. Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores

    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: From Baseline up to approximately 41 months

  15. Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores

    Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with RRMM and newly diagnosed MM.

    Measured: Up to approximately 41 months

  16. Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores

    Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported.

    Measured: Up to approximately 41 months

  17. Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores

    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 approximately 41 months

  18. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores

    The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.

    Measured: Up to approximately 41 months

  19. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores

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

    Measured: Up to approximately 41 months

  20. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores

    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 approximately 41 months

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

    The EORTC IL46 consists of one single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4-point scale.

    Measured: Up to approximately 41 months

Timeline

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

  1. First posted8 Apr 2026
  2. Study start31 May 2026
  3. Primary completion29 Apr 2029 (estimated)
  4. Study completion8 Dec 2032 (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
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518186
Sponsor's protocol ID
79635322MMY3002
Acronym
TRIlogy-5
Status last verified
Sep 2026
First submitted
1 Apr 2026
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 173 sites in 18 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 4 inclusion and 4 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 173 sites in United States, China, Spain, Turkey (Türkiye), Brazil and 13 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?

Complete Response (CR) or Better (time frame: Up to approximately 41 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 NCT07518186.

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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