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Uno studio che confronta JNJ-79635322 e teclistamab in partecipanti con mieloma multiplo recidivante o refrattario (TRIlogy-5)

24 settembre 2026 aggiornato da: Janssen Research & Development, LLC

Uno studio randomizzato di Fase 3 che confronta JNJ-79635322 con Teclistamab in partecipanti con mieloma multiplo recidivante o refrattario dopo 1-3 precedenti linee di terapia, inclusi un anticorpo anti-CD38 e lenalidomide

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Mieloma multiplo

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

700

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Study Contact
Numero di telefono: 844-434-4210
Email: Participate-In-This-Study1@its.jnj.com

Luoghi di studio

Australia
- - Darlinghurst, Australia, 2010
    - Reclutamento
    - St Vincent s Hospital Sydney
  - Garran, Australia, 2605
    - Reclutamento
    - Canberra Hospital
  - Heidelberg, Australia, 3084
    - Reclutamento
    - Austin Hospital
  - Macquarie University, Australia, 2109
    - Reclutamento
    - Macquarie University Hospital
  - Melbourne, Australia, 3128
    - Reclutamento
    - Box Hill Hospital
  - Perth, Australia, 6000
    - Reclutamento
    - Royal Perth Hospital
  - Port Macquarie, Australia, 2444
    - Reclutamento
    - Port Macquarie Base Hospital
Brasile
- - Brasília, Brasile, 70200 730
    - Reclutamento
    - Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
  - Curitiba, Brasile, 81520-060
    - Reclutamento
    - Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
  - Florianópolis, Brasile, 88020 210
    - Reclutamento
    - Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
  - Joinville, Brasile, 89201-260
    - Reclutamento
    - Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
  - Porto Alegre, Brasile, 90050 170
    - Reclutamento
    - Irmandade Santa Casa de Misericordia de Porto Alegre
  - Rio de Janeiro, Brasile, 22775-002
    - Reclutamento
    - Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  - São José do Rio Preto, Brasile, 15090-000
    - Reclutamento
    - Funfarme Sjrp
  - São Paulo, Brasile, 01323 001
    - Reclutamento
    - Real e Benemerita Associacao Portuguesa de Beneficencia
  - São Paulo, Brasile, 05651 901
    - Reclutamento
    - Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  - São Paulo, Brasile, 04537 081
    - Reclutamento
    - Clinica Medica Sao Germano LTDA
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 5G2
    - Reclutamento
    - Arthur J E Child Comprehensive Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Reclutamento
    - Cross Cancer Institute
- Ontario
  - Oshawa, Ontario, Canada, L1G-2B9
    - Reclutamento
    - Lakeridge Health Oshawa
  - Toronto, Ontario, Canada, M5G 2M9
    - Reclutamento
    - Princess Margaret Hospital
Cechia
- - Brno, Cechia, 625 00
    - Reclutamento
    - Fakultni nemocnice Brno
  - Hradec Králové, Cechia, 500 05
    - Reclutamento
    - FN Hradec Kralove
  - Ostrava, Cechia, 708 52
    - Reclutamento
    - Fakultni Nemocnice Ostrava
  - Plzen-Lochotin, Cechia, 323 00
    - Reclutamento
    - FN Plzen
  - Prague, Cechia, 128 08
    - Reclutamento
    - VFN Praha
Cina
- - Beijing, Cina, 100034
    - Reclutamento
    - Peking University First Hospital
  - Beijing, Cina, 100006
    - Reclutamento
    - Peking Union Medical College Hospital
  - Changchun, Cina, 130061
    - Reclutamento
    - The First Hospital of Jilin University
  - Chaoyang District, Cina, 100020
    - Reclutamento
    - Beijing Chaoyang Hospital
  - Chengdu, Cina, 610072
    - Reclutamento
    - Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital
  - Guangzhou, Cina, 510710
    - Reclutamento
    - Sun Yat Sen University Cancer Center
  - Hangzhou, Cina, 310003
    - Reclutamento
    - The First Affiliated Hospital Zhejiang University College of Medicine
  - Nanchang, Cina, 330006
    - Reclutamento
    - The First Affiliated Hospital of NanChang University
  - Nanjing, Cina, 210008
    - Reclutamento
    - Nanjing Drum Tower Hospital
  - Shanghai, Cina, 200434
    - Reclutamento
    - Shanghai Fourth People s Hospital
  - Shenzhen, Cina, 518036
    - Reclutamento
    - Peking University Shenzhen Hospital
  - Tianjin, Cina, 300060
    - Reclutamento
    - Tianjin Medical University Cancer Institute and Hospital
  - Tijian, Cina, 300020
    - Reclutamento
    - Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  - Wenzhou, Cina, 325000
    - Reclutamento
    - The First Affiliated Hospital of Wenzhou Medical University
  - Wuhan, Cina, 430032
    - Reclutamento
    - Wuhan Tongji Hospital Tongji Medical College
  - Xi'an, Cina, 710004
    - Reclutamento
    - The Second Affiliated Hospital of Xi'an Jiaotong University
Corea del Sud
- - Goyang-si, Corea del Sud, 10408
    - Reclutamento
    - National Cancer Center
  - Gyeonggi-do, Corea del Sud, 13620
    - Reclutamento
    - Seoul National University Bundang Hospital
  - Hwasun, Corea del Sud, 58128
    - Reclutamento
    - Chonnam National University Hwasun Hospital
  - Seoul, Corea del Sud, 05505
    - Reclutamento
    - Asan Medical Center
  - Seoul, Corea del Sud, 03080
    - Reclutamento
    - Seoul National University Hospital
  - Seoul, Corea del Sud, 06351
    - Reclutamento
    - Samsung Medical Center
  - Seoul, Corea del Sud, 06591
    - Reclutamento
    - The Catholic University of Korea Seoul St Marys Hospital
Francia
- - Amiens, Francia, 80000
    - Reclutamento
    - CHU Amiens
  - Lyon, Francia, 69002
    - Reclutamento
    - Hospices Civils de Lyon HCL
  - Montpellier, Francia, 34295
    - Reclutamento
    - CHRU Montpellier - Hopital Saint-Eloi
  - Nantes, Francia, 44000
    - Reclutamento
    - CHU Nantes - Hotel Dieu
  - Poitiers, Francia, 86021
    - Reclutamento
    - CHU Poitiers - Hopital la Miletrie
  - Talence, Francia, 33400
    - Reclutamento
    - CHU Bordeaux
  - Toulouse, Francia, 31300
    - Reclutamento
    - CHU Toulouse
  - Tours, Francia, 37000
    - Reclutamento
    - CHRU de Tours
Germania
- - Freiburg im Breisgau, Germania, 79106
    - Reclutamento
    - Universitaetsklinikum Freiburg
  - Hamburg, Germania, 22763
    - Reclutamento
    - Asklepios Klinik Altona
  - Hamburg, Germania, 20251
    - Reclutamento
    - Universitaetsklinikum Hamburg Eppendorf
  - Tübingen, Germania, 72076
    - Reclutamento
    - Universitaetsklinik Tuebingen
Giappone
- - Chiba, Giappone, 260-8717
    - Reclutamento
    - Chiba Cancer Center
  - Fukuoka, Giappone, 810 8563
    - Reclutamento
    - National Hospital Organization Kyushu Medical Center
  - Gunma, Giappone, 371-0034
    - Reclutamento
    - Gunma University Hospital
  - Kamakura-shi, Giappone, 247-8533
    - Reclutamento
    - Shonan Kamakura General Hospital
  - Kyoto, Giappone, 602-8566
    - Reclutamento
    - University Hospital Kyoto Prefectural University of Medicine
  - Matsuyama, Giappone, 790-8524
    - Reclutamento
    - Matsuyama Red Cross Hospital
  - Okayama, Giappone, 701-1192
    - Reclutamento
    - National Hospital Organization Okayama Medical Center
  - Sapporo, Giappone, 060-8604
    - Reclutamento
    - Sapporo City General Hospital
  - Tokyo, Giappone, 135-8550
    - Reclutamento
    - The Cancer Institute Hospital of JFCR
  - Yokohama, Giappone, 241 8515
    - Reclutamento
    - Kanagawa Cancer Center
Grecia
- - Athens, Grecia, 11528
    - Reclutamento
    - Alexandra General Hospital of Athens
  - Athens, Grecia, 106 76
    - Reclutamento
    - Evangelismos S A
  - Athens, Grecia, 124 62
    - Reclutamento
    - University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
  - Ioannina, Grecia, 455 00Q
    - Reclutamento
    - University General Hospital of Ioannina
India
- - Bengaluru, India, 560054
    - Reclutamento
    - M S Ramaiah Medical College and Hospital
  - Gūrgaon, India, 122002
    - Reclutamento
    - Fortis Memorial Research Institute
  - Jaipur, India, 302017
    - Reclutamento
    - Bhagwan Mahaveer Cancer Hospital & Research Centre
  - Kolkata, India, 700156
    - Reclutamento
    - Tata Medical Center
  - Kolkata, India, 700014
    - Reclutamento
    - Nil Ratan Sircar Medical College and Hospital
  - New Delhi, India, 110085
    - Reclutamento
    - Rajiv Gandhi Cancer Institute and Research Centre
  - Pune, India, 411004
    - Reclutamento
    - Deenanath Mangeshkar Hospital and Research Centre
Israele
- - Ashdod, Israele, 7747629
    - Reclutamento
    - Samson Assuta Ashdod University Hospital
  - Haifa, Israele, 3436212
    - Reclutamento
    - Carmel Medical Center
  - Haifa, Israele, 3109601
    - Reclutamento
    - Rambam Med.Center - Hematology Institute
  - Petah Tikva, Israele, 4941492
    - Reclutamento
    - Rabin Medical Center
  - Ramat Gan, Israele, 5266202
    - Reclutamento
    - Sheba Medical Center
  - Tel Aviv, Israele, 6423906
    - Reclutamento
    - Tel Aviv Sourasky Medical Center
Italia
- - Bari, Italia, 70124
    - Reclutamento
    - IRCCS Istituto Tumori Giovanni Paolo II
  - Bologna, Italia, 40138
    - Reclutamento
    - A O U Sant Orsola Malpighi
  - Bolzano, Italia, 39100
    - Reclutamento
    - Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
  - Milan, Italia, 20132
    - Reclutamento
    - Ospedale San Raffaele di Milano
  - Milan, Italia, 20153
    - Reclutamento
    - ASST Santi Paolo e Carlo
  - Novara, Italia, 28100
    - Reclutamento
    - Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
  - Palermo, Italia, 90146
    - Reclutamento
    - Casa di Cura La Maddalena
  - Pescara, Italia, 65124
    - Reclutamento
    - Ospedale S. Spirito, Azienda Sanitaria Pescara
  - Rimini, Italia, 47900
    - Reclutamento
    - Ospedale Infermi Rimini
  - Varese, Italia, 21100
    - Reclutamento
    - ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
Polonia
- - Bydgoszcz, Polonia, 85 168
    - Reclutamento
    - Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
  - Gdansk, Polonia, 80 214
    - Reclutamento
    - Uniwersyteckie Centrum Kliniczne
  - Katowice, Polonia, 40 519
    - Reclutamento
    - Pratia Onkologia Katowice
  - Lublin, Polonia, 20 090
    - Reclutamento
    - Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
  - Warsaw, Polonia, 02-172
    - Reclutamento
    - MTZ Clinical Research Powered by Pratia
  - Wałbrzych, Polonia, 58 309
    - Reclutamento
    - Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu
Spagna
- - Barcelona, Spagna, 08036
    - Reclutamento
    - Hosp. Clinic de Barcelona
  - Barcelona, Spagna, 08035
    - Reclutamento
    - Hosp Univ Vall D Hebron
  - Cáceres, Spagna, 10003
    - Reclutamento
    - Hosp. San Pedro de Alcantara
  - Córdoba, Spagna, 14004
    - Reclutamento
    - Hosp Reina Sofia
  - Jerez de la Frontera, Spagna, 11407
    - Reclutamento
    - Hosp. de Jerez de La Frontera
  - Madrid, Spagna, 28041
    - Reclutamento
    - Hosp. Univ. 12 de Octubre
  - Pamplona, Spagna, 31008
    - Reclutamento
    - Clinica Univ. de Navarra
  - Salamanca, Spagna, 37007
    - Reclutamento
    - Hosp Clinico Univ de Salamanca
  - Santander, Spagna, 39008
    - Reclutamento
    - Hosp. Univ. Marques de Valdecilla
  - Santiago de Compostela, Spagna, 15706
    - Reclutamento
    - Hosp. Clinico Univ. de Santiago
  - Seville, Spagna, 41013
    - Reclutamento
    - Hosp. Virgen Del Rocio
Stati Uniti
- Alabama
  - Birmingham, Alabama, Stati Uniti, 35211
    - Reclutamento
    - Alabama Oncology
- Arizona
  - Phoenix, Arizona, Stati Uniti, 85054
    - Reclutamento
    - Mayo Clinic 1
- Arkansas
  - Springdale, Arkansas, Stati Uniti, 72762
    - Reclutamento
    - Highlands Oncology Group
- California
  - Beverly Hills, California, Stati Uniti, 90211
    - Reclutamento
    - Beverly Hills Cancer Center Clinical Research Advisors LLC
  - Irvine, California, Stati Uniti, 92612
    - Reclutamento
    - UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care
  - Los Angeles, California, Stati Uniti, 90067
    - Reclutamento
    - Valkyrie Clinical Trials
  - Orange, California, Stati Uniti, 92868
    - Reclutamento
    - University of California Irvine Medical Center
- Colorado
  - Denver, Colorado, Stati Uniti, 80218
    - Reclutamento
    - Colorado Blood Cancer Institute
- Connecticut
  - Farmington, Connecticut, Stati Uniti, 06030
    - Reclutamento
    - University of Connecticut Health Center
- Florida
  - Jacksonville, Florida, Stati Uniti, 32224
    - Reclutamento
    - Mayo Clinic Jacksonville
  - Pembroke Pines, Florida, Stati Uniti, 33026
    - Reclutamento
    - Memorial Cancer Institute
- Georgia
  - Atlanta, Georgia, Stati Uniti, 30322
    - Reclutamento
    - Emory University
- Illinois
  - Chicago, Illinois, Stati Uniti, 60607
    - Reclutamento
    - Rush University System for Health
- Indiana
  - Indianapolis, Indiana, Stati Uniti, 46237-8601
    - Reclutamento
    - Franciscan Health
- Iowa
  - Iowa City, Iowa, Stati Uniti, 52242
    - Reclutamento
    - University of Iowa Hospitals and Clinics
  - Waukee, Iowa, Stati Uniti, 50263
    - Reclutamento
    - Mission Cancer Blood University of Iowa Health Care
- Kentucky
  - Louisville, Kentucky, Stati Uniti, 40207
    - Reclutamento
    - Norton Cancer Institute
- Louisiana
  - Shreveport, Louisiana, Stati Uniti, 71103
    - Reclutamento
    - LSU Health Feist Weiller Cancer Center
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21287
    - Reclutamento
    - Johns Hopkins Hospital
- Massachusetts
  - Boston, Massachusetts, Stati Uniti, 02111
    - Reclutamento
    - Tufts Medical Center
- Michigan
  - Detroit, Michigan, Stati Uniti, 48201
    - Reclutamento
    - Karmanos Cancer Institute
- Minnesota
  - Minneapolis, Minnesota, Stati Uniti, 55455
    - Reclutamento
    - University Of Minnesota Medical Center
  - Rochester, Minnesota, Stati Uniti, 55905
    - Reclutamento
    - Mayo Clinic
- Nebraska
  - Omaha, Nebraska, Stati Uniti, 68130
    - Reclutamento
    - Nebraska Cancer Specialists
- New Jersey
  - East Brunswick, New Jersey, Stati Uniti, 08816
    - Reclutamento
    - Astera Cancer Care
- New Mexico
  - Santa Fe, New Mexico, Stati Uniti, 87505
    - Reclutamento
    - Christus St. Vincent Regional Cancer Center
- New York
  - Albany, New York, Stati Uniti, 12208
    - Reclutamento
    - New York Oncology Hematology
  - Mineola, New York, Stati Uniti, 11501
    - Reclutamento
    - Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
  - New York, New York, Stati Uniti, 10016
    - Reclutamento
    - NYU Langone Health Manhattan
  - Shirley, New York, Stati Uniti, 11967
    - Reclutamento
    - New York Cancer and Blood Specialists
- North Carolina
  - Durham, North Carolina, Stati Uniti, 27705
    - Reclutamento
    - Duke University Medical Center
- Ohio
  - Canton, Ohio, Stati Uniti, 44718
    - Reclutamento
    - Gabrail Cancer Center
  - Cincinnati, Ohio, Stati Uniti, 45069
    - Reclutamento
    - The Christ Hospital
  - Dayton, Ohio, Stati Uniti, 45415
    - Reclutamento
    - Dayton Physicians Network Urology
- Oregon
  - Eugene, Oregon, Stati Uniti, 97401
    - Reclutamento
    - Willamette Valley Cancer Institute and Research Center
- South Carolina
  - Greenville, South Carolina, Stati Uniti, 29607
    - Reclutamento
    - Bon Secours Saint Francis Cancer Center
- Tennessee
  - Nashville, Tennessee, Stati Uniti, 37203
    - Reclutamento
    - Tennessee Oncology, PLLC
- Texas
  - Dallas, Texas, Stati Uniti, 75246
    - Reclutamento
    - Baylor University Medical Center
  - Lubbock, Texas, Stati Uniti, 79410
    - Reclutamento
    - Joe Arrington Cancer Research Treatment Center
- Utah
  - Salt Lake City, Utah, Stati Uniti, 84102
    - Reclutamento
    - Utah Cancer Specialists
- Washington
  - Tacoma, Washington, Stati Uniti, 98405
    - Reclutamento
    - NorthWest Medical Specialties, PLLC
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Reclutamento
    - Chang Kung Memorial Hospital
  - Taichung, Taiwan, 40705
    - Reclutamento
    - Taichung Veterans General Hospital
  - Taichung, Taiwan, 40447
    - Reclutamento
    - China Medical University Hospital
  - Tainan, Taiwan, 70403
    - Reclutamento
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 100
    - Reclutamento
    - National Taiwan University Hospital
  - Taipei, Taiwan, 112
    - Reclutamento
    - Taipei Veterans General Hospital
Turchia (Türkiye)
- - Ankara, Turchia (Türkiye), 06680
    - Reclutamento
    - Liv Hospital Ankara
  - Ankara, Turchia (Türkiye), 06010
    - Reclutamento
    - Gulhane Egitim ve Arastirma Hastanesi
  - Ankara, Turchia (Türkiye), 06200
    - Reclutamento
    - Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  - Ankara, Turchia (Türkiye), 06620
    - Reclutamento
    - Ankara University Medical Faculty
  - Ankara, Turchia (Türkiye), 6170
    - Reclutamento
    - Ankara Etlik Sehir Hastanesi
  - Antalya, Turchia (Türkiye), 07025
    - Reclutamento
    - Memorial Antalya Hospital
  - Istanbul, Turchia (Türkiye), 34214
    - Reclutamento
    - Medipol Mega University Hospital
  - Istanbul, Turchia (Türkiye), 34381
    - Reclutamento
    - Istanbul Florance Nightingale Hospital
  - Izmir, Turchia (Türkiye), 35001
    - Reclutamento
    - Izmir Tinaztepe University Galen Hospital
  - Mersin, Turchia (Türkiye), 33110
    - Reclutamento
    - Mersin University Medical Faculty
  - Samsun, Turchia (Türkiye), 55420
    - Reclutamento
    - Ondokuz Mayis University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria:

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

Exclusion criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: Arm A: JNJ-79635322 Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).	Droga: JNJ-79635322 JNJ-79635322 will be administered as SC injection.
Comparatore attivo: Arm B: Teclistamab Participants will receive teclistamab as a SC injection until PD or intolerable toxicity.	Droga: Teclistamab Teclistamab will be administered as SC injection.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Complete Response (CR) or Better Lasso di tempo: Up to approximately 41 months	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) Lasso di tempo: Up to approximately 41 months	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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Overall Response Rate (ORR) Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Very Good Partial Response (VGPR) or Better Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Duration of Response (DoR) Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Minimal Residual Disease (MRD)-negative CR Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
MRD-negative CR at 1 Year Lasso di tempo: 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.	At 1 Year
MRD-negative CR at 5 Years Lasso di tempo: 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.	At 5 Years
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2) Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Overall Survival (OS) Lasso di tempo: Up to approximately 41 months	OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.	Up to approximately 41 months
Time To Next Line of Therapy (TTNT) Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Number of Participants with Abnormalities in Laboratory Parameters Lasso di tempo: Up to approximately 41 months	Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported.	Up to approximately 41 months
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 Lasso di tempo: From Baseline up to approximately 41 months	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.	From Baseline up to approximately 41 months
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 Lasso di tempo: From Baseline up to approximately 41 months	Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.	From Baseline up to approximately 41 months
Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores Lasso di tempo: From Baseline up to approximately 41 months	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.	From Baseline up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores Lasso di tempo: Up to approximately 41 months	Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported.	Up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores Lasso di tempo: Up to approximately 41 months	The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.	Up to approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores Lasso di tempo: Up to approximately 41 months	Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.	Up to approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months
Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46 Lasso di tempo: Up to approximately 41 months	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.	Up to approximately 41 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 maggio 2026

Completamento primario (Stimato)

29 aprile 2029

Completamento dello studio (Stimato)

8 dicembre 2032

Date di iscrizione allo studio

Primo inviato

1 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 aprile 2026

Primo Inserito (Effettivo)

8 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

79635322MMY3002

Piano per i dati dei singoli partecipanti (IPD)

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SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Uno studio che confronta JNJ-79635322 e teclistamab in partecipanti con mieloma multiplo recidivante o refrattario (TRIlogy-5)

Uno studio randomizzato di Fase 3 che confronta JNJ-79635322 con Teclistamab in partecipanti con mieloma multiplo recidivante o refrattario dopo 1-3 precedenti linee di terapia, inclusi un anticorpo anti-CD38 e lenalidomide

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Tipo di studio

Iscrizione (Stimato)

Fase

Contatti e Sedi

Contatto studio

Luoghi di studio

Criteri di partecipazione

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Età idonea allo studio

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Dettagli di progettazione

Numero di armi

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Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

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Misure di risultato secondarie

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Collaboratori e investigatori

Sponsor

Investigatori

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Stimato)

Completamento dello studio (Stimato)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti