A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
MonumenTAL-6
64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom
2 other identifiers
interventional
838
26 countries
235
Brief Summary
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
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 Jan 2024
235 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
January 5, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedStudy Start
First participant enrolled
January 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedJuly 30, 2026
July 1, 2026
2.2 years
January 5, 2024
July 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.
Up to 3 years 5 months
Secondary Outcomes (21)
Overall Response Rate (ORR)
Up to 3 years 5 months
Complete Response (CR) or Better Rate
Up to 3 years 5 months
Very Good Partial Response (VGPR) or Better Rate
Up to 3 years 5 months
Minimal Residual Disease (MRD)-negative CR Rate
Up to 3 years 5 months
Overall Survival (OS)
Up to 3 years 5 months
- +16 more secondary outcomes
Study Arms (3)
Arm A: Talquetamab + Pomalidomide (Tal-P)
EXPERIMENTALParticipants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Arm B: Talquetamab + Teclistamab (Tal-Tec)
EXPERIMENTALParticipants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)
ACTIVE COMPARATORParticipants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.
Interventions
Talquetamab will be administered as a SC injection.
Pomalidomide will be administered orally.
Teclistamab will be administered as a SC injection.
Elotuzumab will be administered intravenously.
Dexamethasone will be administered either orally or intravenously.
Bortezomib will be administered as a SC injection.
Eligibility Criteria
You may qualify if:
- Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level \>= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (\>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (\<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment
- Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
- 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
You may not qualify if:
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
- Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
- A maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (242)
UCSF Fresno
Clovis, California, 93611, United States
UCLA
Santa Monica, California, 90404, United States
Yale University School Of Medicine
New Haven, Connecticut, 06519, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, 30322, United States
City of Hope Cancer Center
Newnan, Georgia, 30265, United States
Kootenai Health
Coeur d'Alene, Idaho, 83814, 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
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808, United States
Luminis Health Center for Cancer and Blood Disorders
Annapolis, Maryland, 21401, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21287, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Cancer Institute
Detroit, Michigan, 48202, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
University of Nebraska
Omaha, Nebraska, 68105, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Weill Cornell Medical College
New York, New York, 10065, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Louis Stokes Cleveland VA Med Ctr
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health And Science University
Portland, Oregon, 97239, United States
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107 4215, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-8900, United States
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
UT Southwestern Parkland Hospital
Dallas, Texas, 75390, United States
UT Southwestern
Dallas, Texas, 75390, United States
Houston Methodist Neal Cancer Center at Texas Medical Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Fundaleu
Buenos Aires, C1114AAN, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB, Argentina
Hospital Aleman
CABA, C1118AAT, Argentina
Royal Adelaide Hospital
Adelaide, 5000, Australia
Box Hill Hospital
Box Hill, 3128, Australia
St Vincents Hospital
Darlinghurst, 2010, Australia
St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
Gold Coast University Hospital
Southport, 4215, Australia
Perth Blood Institute
West Perth, 6005, Australia
Wollongong Hospital
Wollongong, 2500, Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 05020, Austria
Klinik Ottakring
Vienna, 1160, Austria
Medical University Vienna MUV
Vienna, A-1090, Austria
Grand Hopital De Charleroi Site Les Viviers
Charleroi, 6060, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-Niklaas, 9100, Belgium
Cetus Oncologia
Belo Horizonte, 30110-022, Brazil
DF Star
Brasília, 70390-140, Brazil
Fundacao Universidade de Caxias do Sul
Caxias do Sul, 95070 560, Brazil
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, 81520-060, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035-903, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Recife, 50070-480, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22793-080, Brazil
Hospital Sao Rafael
Salvador, 41253 190, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090 000, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 001, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Clinica Medica Sao Germano S/S LTDA
São Paulo, 04537-081, Brazil
Instituto D Or de Pesquisa e Ensino
São Paulo, 04543 000, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z4E6, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 1V7, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V5C2, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G2M9, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Beijing Chaoyang Hospital
Beijing, 100020, China
Peking University First Hospital
Beijing, 100034, China
Peking University People's Hospital
Beijing, 101199, China
The Second Xiangya Hospital of Central South Hospital
Changsha, 410011, China
Changzhou No 2 Peoples Hospital
Changzhou, 213000, China
Sichuan Provincial Peoples Hospital
Chengdu, 610032, China
Fujian Meidical University Union Hospital
Fuzhou, 350001, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, 510515, China
First hospital affiliated of Zhejiang Medical university
Hangzhou, 310003, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, 310009, China
The Affiliated Hospital of Inner Mongolia Medical College
Hohhot, 010051, China
Qilu Hospital of Shandong University
Jinan, 250012, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
Shanghai, 200025, China
Tongji Hospital of Tongji University
Shanghai, 200065, China
Shanghai Fourth People s Hospital
Shanghai, 200434, China
Shengjing Hospital Of China Medical University
Shenyang, 110055, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
Shanxi Bethune Hospital
Taiyuan, 030032, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 30060, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, 430030, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
The first affiliated hospital of xiamen university
Xiamen, 361026, China
Fakultni nemocnice Brno
Brno-Bohunice, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
University Hospital Olomouc
Olomouc, 779 00, Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 52, Czechia
Aarhus University Hospital
Aarhus, 8200, Denmark
Odense University Hospital
Odense C, 5000, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Hopital Claude Huriez
Lille, 59000, France
CHU de Limoges Hopital Dupuytren
Limoges, 87042, France
Hospices Civils de Lyon HCL
Lyon, 69002, France
Institut Paoli Calmettes
Marseille, 13009, France
CHU Nantes
Nantes, 44093, France
Hopital Saint Louis
Paris, 75010, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604, France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, 67200, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31100, France
CHRU Tours Hopital Bretonneau
Tours, 37044, France
Klinikum Augsburg
Augsburg, 86156, Germany
Universitaetsklinikum Halle Saale
Halle, 06120, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Magdeburg A.oe.R
Magdeburg, 39120, Germany
Klinikum rechts der Isar der TU Muenchen
München, 81675, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
251 Airforces Hospital
Athens, 115 25, Greece
Alexandra General Hospital of Athens
Athens, 115 28, Greece
Theageneio Cancer Hospital
Thessaloniki, 546 39, Greece
Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
Budapest, 1088, Hungary
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest, 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza, 4400, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7624, Hungary
Fortis Memorial Research Institute
Gurgaon, 122002, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, 226014, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004, India
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, 70300, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Rabin Medical center - Petah-Tikva
Petah Tikva, 49100, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Alessandria, 15121, Italy
A O U Sant Orsola Malpighi
Bologna, 40138, Italy
oncologia medica - Oncology
Brindisi, 72100, Italy
ARNAS Garibaldi P O Nesima
Catania, 95122, Italy
Ospedale Policlinico San Martino IRCCS
Genova, 16132, Italy
Asst Ovest Milanese - Ospedale Di Legnano
Legnano, 20025, Italy
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Presidio Ospedaliero Pescara
Pescara, 65124, Italy
Ospedale S. Maria Delle Croci
Ravenna, 48121, Italy
Oncologia Medica-Città Della Salute E Della Scienza Di Torino
Torino, 10126, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37134, Italy
Juntendo University Hospital
Bunkyō City, 113 8431, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Hamamatsu University Hospital
Hamamatsu, 431 3192, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
National Hospital Organization Nagasaki Medical Center
Nagasaki, 856-8562, Japan
Japanese Red Cross Narita Hospital
Narita, 286-8523, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Hyogo Medical University Hospital
Nishinomiya Shi, 663 8501, Japan
Japanese Red Cross Osaka Hospital
Osaka, 543-8555, Japan
Sapporo City General Hospital
Sapporo, 060-8604, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
Japanese Red Cross Medical Center
Shibuya-ku, 150-8935, Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
The University of Osaka Hospital
Suita, 565 0871, Japan
Shizuoka Cancer Center
Sunto Gun, 411 8777, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550, Japan
Tottori University Hospital
Tottori, 683-0824, Japan
University of Tsukuba Hospital
Tsukuba, 305 8576, Japan
Kanagawa Cancer Center
Yokohama, 241 8515, Japan
Centro de Quimioterapia e Investigacion
Guadalajara, 45645, Mexico
Hematologica Alta Especialidad
Huixquilucan, 52787, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Flevoziekenhuis
Almere Stad, 1315RA, Netherlands
Catharinaziekenhuis
Eindhoven, 5623 EJ, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Haga ziekenhuis
The Hague, 2545 CH, Netherlands
Isala Kliniek
Zwolle, 8025 AB, Netherlands
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, 21 500, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, 36-200, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734, Poland
Centrum Onkologii Ziemii Lubelskiej
Lublin, 20-090, Poland
Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
Szczecin, 71-252, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 367, Poland
King Abdullah International Medical Research Center (KAIMRC)
Riyadh, 11481, Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, 11564, Saudi Arabia
King Fahad Medical City
Riyadh, 12231, Saudi Arabia
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Hosp. de Cabuenes
Asturias, 33394, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. Univ. de Burgos
Burgos, 09003, Spain
Hosp. San Pedro de Alcantara
Cáceres, 10003, Spain
Hosp. Univ. Donostia
Donostia / San Sebastian, 20014, Spain
Hosp. Univ. Virgen de Las Nieves
Granada, 18014, Spain
Hosp. Univ. Lucus Augusti
Lugo, 27003, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Son Espases
Palma de Mallorca, 07120, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Complejo Hosp de Navarra - Hosp de Navarra
Pamplona, 31008, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Skanes universitetssjukhus
Lund, 221 85, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Varberg Hospital
Varberg, 432 81, Sweden
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, 06620, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680, Turkey (Türkiye)
Pamukkale Universitesi Tip Fakultesi
Denizli, 20070, Turkey (Türkiye)
Medipol University Hospital
Istanbul, 34214, Turkey (Türkiye)
Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
Samsun, 55200, Turkey (Türkiye)
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
University Hospital of Wales
Cardiff, CF14 4HY, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2024
First Posted
January 17, 2024
Study Start
January 22, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.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.