A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
MajesTEC-7
A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
5 other identifiers
interventional
1,590
24 countries
263
Brief Summary
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Oct 2022
Longer than P75 for phase_3 multiple-myeloma
263 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedStudy Start
First participant enrolled
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 28, 2033
September 25, 2026
September 1, 2026
8.5 years
September 21, 2022
September 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS)
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria.
From randomization to the date of disease progression or death (Up to 09 years)
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria.
At Month 12
Secondary Outcomes (17)
Very Good Partial Response (VGPR) or Better
From randomization up to 09 years
Complete Response (CR) or Better
From randomization up to 09 years
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
From randomization up to 09 years
MRD-negative CR
From randomization up to 09 years
Progression Free Survival on Next-line Therapy (PFS2)
From randomization up to 09 years
- +12 more secondary outcomes
Study Arms (3)
Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
EXPERIMENTALParticipants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.
Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
EXPERIMENTALParticipants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.
Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
ACTIVE COMPARATORParticipants will receive daratumumab as SC injection with lenalidomide and dexamethasone.
Interventions
Talquetamab will be administered as SC injection.
Teclistamab will be administered as SC injection.
Daratumumab will be administered as SC injection.
Lenalidomide will be administered orally.
Dexamethasone will be administered either orally or intravenously (IV).
Eligibility Criteria
You may qualify if:
- Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
- A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
You may not qualify if:
- Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization
- Had plasmapheresis within 28 days of randomization
- Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
- Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
- Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
- Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (270)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
UCSF Fresno
Clovis, California, 93611, United States
City of Hope Duarte
Duarte, California, 91010, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
University of Connecticut
Farmington, Connecticut, 06030, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware, 19713, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando, Florida, 32804, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
City of Hope Cancer Center
Newnan, Georgia, 30265, United States
University Of Illinois Medical Center
Chicago, Illinois, 60612, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Iowa Health Care
Waukee, Iowa, 50263, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
LSUHSC Shreveport Feist-Weiller Cancer Center
Shreveport, Louisiana, 71103, United States
Johns Hopkins University School of Medicine JHUSOM
Baltimore, Maryland, 21231, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202, United States
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan, 49503, United States
Henry Ford Providence Novi Hospital
Novi, Michigan, 48374, United States
Henry Ford Providence Southfield CK Potluri Cancer Center
Southfield, Michigan, 48075, United States
MidAmerica Cancer Care
Kansas City, Missouri, 64132, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057, United States
Northwell Health Cancer Institute
Lake Success, New York, 11042, United States
NYU Langone Hospital Long Island
Mineola, New York, 11500, United States
Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Novant Health
Charlotte, North Carolina, 28204, United States
Durham VAMC
Durham, North Carolina, 27705, United States
Novant Health Zimmer Cancer Institute
Wilmington, North Carolina, 28401, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care
Cincinnati, Ohio, 45236, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
The Ohio State University- James Cancer Hospital
Columbus, Ohio, 43210, United States
OhioHealth
Columbus, Ohio, 43214, United States
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, 17033, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MUSC-Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Joe Arrington Cancer Research Treatment Center
Lubbock, Texas, 79410, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, 22060, United States
Virginia Oncology Associates Brock Cancer Center
Norfolk, Virginia, 23502, United States
Richmond VA Medical Center
Richmond, Virginia, 23249, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Royal Prince Alfred Hospital
Camperdown, 2050, Australia
Barwon Health - University Hospital Geelong
Geelong, 3220, Australia
Liverpool Hospital
Liverpool, 2170, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
Calvary Mater Newcastle Hospital
New South Wales, 2298, Australia
Wollongong Hospital
Wollongong, 2500, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
SCRI CCCIT gem GmbH
Salzburg, 5020, Austria
Medical University Vienna
Vienna, 1090, Austria
Hanusch Krankenhaus
Vienna, 1140, Austria
Institut Jules Bordet
Anderlecht, 1070, Belgium
ZAS Cadix
Antwerp, 2030, Belgium
ZAS Augustinus
Antwerp, 2610, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Jolimont
Haine Saint Paul La Louviere, 7100, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Fundacao Pio XII
Barretos, 14784 400, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150 320, Brazil
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, 81520-060, Brazil
Instituto Do Cancer Do Ceara
Fortaleza, 60430-230, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062-000, Brazil
Complexo Hospitalar de Niteroi
Niterói, 24030-103, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, 14051140, Brazil
IDOR - Regional Bahia
Salvador, 41253-190, Brazil
Hospital Nove de Julho
São Paulo, 01409-902, Brazil
Clinica Medica Sao Germano LTDA
São Paulo, 04537 081, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403 000, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z4E6, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G-2B9, Canada
CHU de Quebec L Hotel Dieu de Quebec
Québec, Quebec, G1J 1Z4, Canada
Peking Union Medical College Hospital
Beijing, 100006, China
Peking University First Hospital
Beijing, 100034, China
Beijing Tongren Hospital CMU
Beijing, 100051, China
The First Hospital of Jilin University
Changchun, 130061, China
The Second Xiangya Hospital of Central South Hospital
Changsha, 410011, China
Changzhou No 2 Peoples Hospital
Changzhou, 213004, China
Beijing Chaoyang Hospital
Chaoyang District, 100020, China
Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Fujian Meidical University Union Hospital
Fuzhou, 350001, China
Nanfang Hospital
Guangzhou, 510515, China
Sun Yat -Sen University Cancer Center
Guangzhou, 511363, China
No.1 Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, 310003, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, 310003, China
Harbin medical university cancer hospital
Harbin, 150081, China
Qilu Hospital of Shandong University
Jinan, 250012, China
The First Affliated Hospital Of Nanchang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Zhongda Hospital Southeast University
Nanjing, 214135, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127, China
Shanghai Fourth People s Hospital
Shanghai, 200434, China
Shengjing Hospital Of China Medical University
Shenyang, 110022, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
Institute of Hematology and Blood Diseases Hospital
Tianjin, 301609, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Wuhan Tongji Hospital Tongji Medical College
Wuhan, 430032, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
The first affiliated hospital of xiamen university
Xiamen, 361003, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni nemocnice Brno
Brno-Bohunice, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 52, Czechia
Fakultni nemocnice Plzen
Pilsen, 304 60, Czechia
VFN v Praze
Prague, 128 08, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Regionshospitalet Godstrup
Herning, 7400, Denmark
Zealand University Hospital
Roskilde, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
CHU Henri Mondor
Créteil, 94010, France
Hopital Claude Huriez
Lille, 59000, France
Hospices Civils de Lyon HCL
Lyon, 69002, France
CHU Nantes
Nantes, 44093, France
CHU Hopital Saint Antoine
Paris, 75571, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604, France
CHU Poitiers - Hopital la Miletrie
Poitiers, 86021, France
CHU de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059, France
Helios Kliniken Berlin Buch Gmbh
Berlin, 13125, Germany
Med. Universitatsklinik Essen
Essen, 45147, Germany
Universitaetsklinikum Halle Saale
Halle, 06120, Germany
Universitaetsklinik Hamburg-Eppendorf
Hamburg, 20251, Germany
Klinikum Nuernberg Nord
Nuremberg, 90419, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, 72076, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
Alexandra General Hospital of Athens
Athens Attica, 115 28, Greece
Theageneio Cancer Hospital
Thessaloniki, 546 39, Greece
G Papanikolaou Hospital of Thessaloniki
Thessalonikis, 570 10, Greece
Soroka Medical Center
Beersheba, 8457108, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Rabin
Petah Tikva, 49100, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
ASST Papa Giovanni XXIII Bergamo
Bergamo, 24127, Italy
A O U Sant Orsola Malpighi
Bologna, 40138, Italy
Careggi University Hospital
Florence, 50134, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, 80131, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, 27100, Italy
Universita Degli Studi di Roma Tor Vergata
Roma, 00133, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Juntendo University Hospital
Bunkyō City, 113 8431, Japan
Chiba Cancer Center
Chiba, 260 0801, Japan
Kameda Medical Center
Chiba, 296-0041, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 311-3193, Japan
Kansai Medical University Hospital
Hirakata, 573 1191, Japan
Hyogo Medical University Hospital
Hyôgo, 663-8501, Japan
Saitama Medical University Hospital
Iruma-gun, 350-0495, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Matsuyama Red Cross Hospital
Matsuyama, 790-8524, Japan
National Hospital Organization Nagasaki Medical Center
Nagasaki, 856-8562, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Osaka Metropolitan University Hospital
Osaka, 545 8586, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, 003-0804, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa, 377-0280, Japan
Japanese Red Cross Medical Center
Shibuya-ku, 150-8935, Japan
Shizuoka Cancer Center
Sunto Gun, 411 8777, Japan
Fujita Health University Hospital
Toyoake, 470-1192, Japan
Yamagata University Hospital
Yamagata, 990 2331, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506, Japan
VUMC Amsterdam
Amsterdam, 1081 HV, Netherlands
Gelre Ziekenhuis
Apeldoorn, 7334 DZ, Netherlands
Reinier de Graaf Gasthuis
Delft, 2625 AD, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Zuyderland Medical Center
Sittard-Geleen, 6162 BG, Netherlands
Oslo University Hospital HF Ulleval sykehus
Oslo, 0450, Norway
St. Olavs Hospital
Trondheim, 7030, Norway
Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
Biała Podlaska, 21 500, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, 36-200, Poland
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Pratia Onkologia Katowice
Katowice, 40 519, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, 93 513, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20 090, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
Lublin, 20-081, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569, Poland
Uniwersyteckie Centrum Kliniczne
Warsaw, 02 097, Poland
Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze
Zielona Góra, 65 046, Poland
Uls Braga - Hosp. Braga
Braga, 4710-243, Portugal
Champalimaud Foundation Champalimaud Centre
Lisbon, 1400-038, Portugal
Uls Hosp Sao Joao
Porto, 4200 319, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, 4200072, Portugal
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Institut Catala d Oncologia L Hospitalet
Barcelona, 08908, Spain
Hosp. Univ. Virgen de Las Nieves
Granada, 18014, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp Univ Hm Sanchinarro
Madrid, 28050, Spain
Hosp. Univ. Son Espases
Palma de Mallorca, 07120, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Mutua Terrassa
Terrassa, 08221, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Falu Lasarett
Falun, 791 82, Sweden
Skanes universitetssjukhus
Lund, 221 85, Sweden
Universitetssjukhuset Orebro
Örebro, 701 85, Sweden
Karolinska University Hospital Huddinge
Stockholm, 141 86, Sweden
Inselspital Universitatsspital Bern
Bern, 3010, Switzerland
Kantonsspital St Gallen
Sankt Gallen, 9007, Switzerland
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, 06620, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680, Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, 07025, Turkey (Türkiye)
Pamukkale University Medical Faculty
Denizli, 20160, Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, 35340, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55280, Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW, United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
Bristol NHS Foundation Trust
Bristol, BS1 3NU, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
University College London Hospitals
London, NW1 2BU, United Kingdom
Imperial College Healthcare
London, W12 0HS, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 21, 2022
First Posted
September 23, 2022
Study Start
October 25, 2022
Primary Completion (Estimated)
April 30, 2031
Study Completion (Estimated)
October 28, 2033
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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