Clinical trial NCT06208150: 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
Official title: 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 Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 795
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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 6months after the last dose of study treatment

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 6 years 5 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 6 years 5 months
measure: Complete Response (CR) or Better Rate
timeFrame: Up to 6 years 5 months
measure: Very Good Partial Response (VGPR) or Better Rate
timeFrame: Up to 6 years 5 months
measure: Minimal Residual Disease (MRD)-negative CR Rate
timeFrame: Up to 6 years 5 months
measure: Overall Survival (OS)
timeFrame: Up to 6 years 5 months
measure: Progression Free Survival on Next-line Therapy (PFS2)
timeFrame: Up to 6 years 5 months
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 6 years 5 months
measure: Serum Concentration of Talquetamab and Teclistamab
timeFrame: Up to 6 years 5 months
measure: Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab
timeFrame: Up to 6 years 5 months
measure: Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
timeFrame: Up to 6 years 5 months
measure: Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
timeFrame: Up to 6 years 5 months
measure: Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
timeFrame: Up to 6 years 5 months
measure: Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)
timeFrame: Up to 6 years 5 months
measure: Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
timeFrame: Up to 6 years 5 months
measure: Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q
timeFrame: Up to 6 years 5 months
measure: Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
timeFrame: Up to 6 years 5 months
measure: Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L
timeFrame: Up to 6 years 5 months
measure: Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
timeFrame: Up to 6 years 5 months
measure: Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
timeFrame: Up to 6 years 5 months
measure: Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
timeFrame: Up to 6 years 5 months
Other outcomes:
Locations:
city: Clovis
country: United States
facility: UCSF Fresno
state: California
city: Santa Monica
country: United States
facility: UCLA
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants, PA
state: Delaware
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute Emory University
state: Georgia
city: Coeur d'Alene
country: United States
facility: Kootenai Health
state: Idaho
city: Waukee
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Annapolis
country: United States
facility: Luminis Health Center for Cancer and Blood Disorders
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Cancer Institute
state: Michigan
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Med Ctr
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health And Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Ctr
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Bon Secours Saint Francis Cancer Center
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Houston Methodist Neal Cancer Center at Texas Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Tacoma
country: United States
facility: NorthWest Medical Specialties, PLLC
state: Washington
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Fundaleu
city: Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Darlinghurst
country: Australia
facility: St Vincents Hospital
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: West Perth
country: Australia
facility: Perth Blood Institute
city: Wollongong
country: Australia
facility: Wollongong Hospital
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Vienna
country: Austria
facility: Klinik Ottakring
city: Vienna
country: Austria
facility: Medical University Vienna MUV
city: Charleroi
country: Belgium
facility: Grand Hopital De Charleroi Site Les Viviers
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas - Campus Sint-Niklaas Moerland
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia
city: Brasilia
country: Brazil
facility: DF Star
city: Caxias do Sul
country: Brazil
facility: Fundacao Universidade de Caxias do Sul
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
city: Porto Alegre
country: Brazil
facility: Hospital De Clinicas De Porto Alegre
city: Recife
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Clinica Medica Sao Germano S/S LTDA
city: Sao Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino
city: Calgary
country: Canada
facility: Arthur J E Child Comprehensive Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre University Health Network
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People s Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South Hospital
city: Changzhou
country: China
facility: Changzhou No 2 Peoples Hospital
city: Chengdu
country: China
facility: Sichuan Provincial Peoples Hospital
city: Fuzhou
country: China
facility: Fujian Meidical University Union Hospital
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical Hospital
city: Hangzhou
country: China
facility: First hospital affiliated of Zhejiang Medical university
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College of Medicine
city: Hu He Hao Te Shi
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical College
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Nan Ning Shi
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
city: Shanghai
country: China
facility: Shanghai Fourth People s Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Tai Yuan Shi
country: China
facility: Shanxi Bethune Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Brno - Bohunice
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Lille
country: France
facility: Hopital Claude Huriez
city: Limoges
country: France
facility: CHU de Limoges Hopital Dupuytren
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hopital Saint Louis
city: Pessac Cedex
country: France
facility: CHU de Bordeaux - Hospital Haut-Leveque
city: Pierre Benite
country: France
facility: CHU Lyon Sud
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe ICANS
city: Toulouse Cedex 9
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
city: TOURS Cedex 01
country: France
facility: CHRU Tours Hopital Bretonneau
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle Saale
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.oe.R
city: München
country: Germany
facility: Klinikum rechts der Isar der TU Muenchen
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Athens
country: Greece
facility: 251 Airforces Hospital
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
city: Thessaloniki
country: Greece
facility: Anticancer Hospital of Thessaloniki Theageneio
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
city: Budapest
country: Hungary
facility: Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Nyiregyhaza
country: Hungary
facility: Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Gurgaon
country: India
facility: Fortis Memorial Research Institute
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
city: Be'er Ya'akov
country: Israel
facility: Shamir Medical Center Assaf Harofeh
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Petah-Tikva
country: Israel
facility: Rabin Medical center - Petah-Tikva
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
city: Bologna
country: Italy
facility: A O U Sant Orsola Malpighi
city: Brindisi
country: Italy
facility: oncologia medica - Oncology
city: Catania
country: Italy
facility: ARNAS Garibaldi P O Nesima
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Legnano
country: Italy
facility: Asst Ovest Milanese - Ospedale Di Legnano
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pescara
country: Italy
facility: Presidio Ospedaliero Pescara
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci
city: Torino
country: Italy
facility: Oncologia Medica-Città Della Salute E Della Scienza Di Torino
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Bunkyo Ku
country: Japan
facility: Juntendo University Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Nagasaki
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
city: Narita
country: Japan
facility: Japanese Red Cross Narita Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Nishinomiya shi
country: Japan
facility: Hyogo Medical University Hospital
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
city: Suita City
country: Japan
facility: The University of Osaka Hospital
city: Sunto Gun
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tottori
country: Japan
facility: Tottori University Hospital
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Yokohama City
country: Japan
facility: Kanagawa Cancer Center
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Guadalajara
country: Mexico
facility: Centro de Quimioterapia e Investigacion
city: Huixquilucan
country: Mexico
facility: Hematologica Alta Especialidad
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Den Haag
country: Netherlands
facility: Haga ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharinaziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Zwolle
country: Netherlands
facility: Isala Kliniek
city: Biala Podlaska
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemii Lubelskiej
city: Szczecin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
city: Riyadh
country: Saudi Arabia
facility: King Abdullah International Medical Research Center (KAIMRC)
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Asturias
country: Spain
facility: Hosp. de Cabuenes
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Burgos
country: Spain
facility: Hosp. Univ. de Burgos
city: Cáceres
country: Spain
facility: Hosp. San Pedro de Alcantara
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
city: Lugo
country: Spain
facility: Hosp. Univ. Lucus Augusti
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Palma de Mallorca
country: Spain
facility: Hosp. Univ. Son Espases
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Pamplona
country: Spain
facility: Complejo Hosp de Navarra - Hosp de Navarra
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: San Sebastian
country: Spain
facility: Hosp. Univ. Donostia
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Lund
country: Sweden
facility: Skanes universitetssjukhus
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Varberg
country: Sweden
facility: Varberg Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Liv Hospital Ankara
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty
city: Istanbul
country: Turkey
facility: Medipol University Hospital
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: