Clinical trial NCT05827016: A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
Official title: A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Iberdomide
CC-220
Lenalidomide
MM
NDMM
Maintenance
Autologous stem cell transplant
ASCT
CELMoD
Cereblon Modulators
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 1216
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 iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).


Eligibility criteria: Inclusion Criteria

* Confirmed diagnosis of symptomatic multiple myeloma (MM).
* Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
* Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) \[eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)\] with or without a CD38 monoclonal antibody, daratumumab + bortezomib/thalidomide/dexamethasone \[D-VTd\] and daratumumab + bortezomib/ lenalidomide/dexamethasone \[D-VRd\]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone \[D-VCd\], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
* Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.

Exclusion Criteria

* Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
* Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
* Known central nervous system/meningeal involvement of MM.
* Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 6 years
Secondary outcomes:
measure: Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment
timeFrame: Up to 6 years
measure: Overall Survival
timeFrame: Up to 12 years
measure: Recommended iberdomide dose for Stage 2
timeFrame: Up to 1 year
measure: Area under the iberdomide plasma concentration-time curve from time zero to tau
timeFrame: Up to 1 year
measure: Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)
timeFrame: Up to 1 year
measure: Maximum iberdomide concentration (Cmax)
timeFrame: Up to 1 year
measure: Time to maximum iberdomide plasma concentration (Tmax)
timeFrame: Up to 1 year
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 6 years
measure: Progression-free survival on next line of treatment (PFS2)
timeFrame: Up to 6 years
measure: Achieving MRD negativity in participants with CR or better at any time after the date of randomization
timeFrame: Up to 6 years
measure: Conversion from MRD positive to MRD negative in participants with CR or better
timeFrame: Up to 6 years
measure: Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments
timeFrame: Up to 6 years
measure: Time to progression (TTP)
timeFrame: Up to 6 years
measure: Time to next treatment (TTNT)
timeFrame: Up to 6 years
measure: Best response achieved prior to progressive disease (PD)
timeFrame: Up to 6 years
measure: Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30)
timeFrame: Up to 6 years
measure: Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Athens
country: United States
facility: University Cancer Blood Ctr
state: Georgia
city: Atlanta
country: United States
facility: The Winship Cancer Institute of Emory University
state: Georgia
city: Augusta
country: United States
facility: Augusta University - Georgia Cancer Center
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
state: Kansas
city: Clinton
country: United States
facility: Maryland Oncology Hematology, PA- Clinton
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan - Rogel Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan (CHCWM)
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center (MCCC) - Rochester
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic - Hematology & Oncology
state: Mississippi
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-Mineola
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - Herbert Irving Pavilion Location
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: Charlotte
country: United States
facility: Novant Health Cancer Institute - Elizabeth
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Cancer Institute Hematology - Forsyth
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 0322
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Kansas
country: United States
facility: Midwest Oncology Associates - Kansas City
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Centers
state: Ohio
city: Wooster
country: United States
facility: Wooster Milltown Specialty and Surgery Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Jeanes Campus
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh - Hillman Cancer Center
state: Pennsylvania
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern-Harold C. Simmons Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Mar del Plata
country: Argentina
facility: Local Institution - 0259
state: B
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: B
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Caba
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"
state: Caba
city: Córdoba
country: Argentina
facility: Sanatorio Allende
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien - Universitaetsklinik fuer Augenheilkunde und Optometrie
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi - Les Viviers
state: WHT
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Kennedylaan
city: Curitiba
country: Brazil
facility: Local Institution - 0245
state: PR
city: Niterói
country: Brazil
facility: Local Institution - 0214
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0082
state: RJ
city: Ribeirão Preto
country: Brazil
facility: Local Institution - 0081
state: SP
city: Sao Paulo
country: Brazil
facility: Local Institution - 0277
state: SP
city: São Paulo
country: Brazil
facility: Local Institution - 0194
state: SP
city: São Paulo
country: Brazil
facility: Local Institution - 0241
state: SP
city: Barretos
country: Brazil
facility: Local Institution - 0190
city: Porto Alegre
country: Brazil
facility: Local Institution - 0083
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0096
city: Salvador
country: Brazil
facility: Local Institution - 0098
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec
country: Canada
facility: CHUQ - The Hôtel-Dieu de Québec
city: Santiago
country: Chile
facility: Fundación Arturo López Pérez
city: Temuco
country: Chile
facility: Local Institution - 0258
city: Vitacura
country: Chile
facility: Clinica Alemana - Vitacura
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: AH
city: Beijing
country: China
facility: Local Institution - 0326
state: Beijing
city: Beijing
country: China
facility: The Fifth Medical Center of People's Liberation Army General Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Local Institution - 0321
state: CQ
city: Guangzhou Shi
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Zhengzhou City
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital - The Comprehensive Cancer Center
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University - Donghu District
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an City
country: China
facility: The First Affiliated Hospital of the Air Force Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Local Institution - 0318
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0271
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0319
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital - Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Local Institution - 0320
state: Zhejiang
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
city: Suzhou Shi
country: China
facility: The First Affiliated Hospital of Soochow University
city: Wenzhou Shi
country: China
facility: Wenzhou Medical University - The First Affiliated Hospital
city: Wuhan Shi
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
city: Monteria
country: Colombia
facility: Local Institution - 0302
state: COR
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerología - Bogota
city: Bogota
country: Colombia
facility: Fundacion Centro de Tratamiento e Investigacion sobre Cancer Luis Carlos Sarmiento Angulo - CTIC
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander - FOSCAL
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Valledupar
country: Colombia
facility: Sociedad de Oncologia y Hematologia del Cesar S.A.S
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultní Nemocnice Olomouc
city: Prague 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Prague
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Helsinki
country: Finland
facility: Helsingin Yliopistollinen Sairaala (HUS) - Syopakeskus (Comprehensive Cancer Center)
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Amiens Cedex 1
country: France
facility: CHU Hôpital Sud
city: Caen
country: France
facility: Institut d'Hématologie de Basse-Normandie (IHBN)
city: Creteil
country: France
facility: CHU Hôpital Henri Mondor
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Départemental Vendée - Hôpital de la Roche-sur-Yon
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
city: Limoges
country: France
facility: CHU Limoges - Hôpital Dupuytren
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
city: Cottbus
country: Germany
facility: Local Institution - 0314
state: BB
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
state: BE
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: BW
city: Augsburg
country: Germany
facility: Local Institution - 0324
state: BY
city: Bayreuth
country: Germany
facility: Local Institution - 0312
state: BY
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen - Medizinische Klinik 5
state: BY
city: Muenchen
country: Germany
facility: Local Institution - 0311
state: BY
city: Hamburg
country: Germany
facility: Local Institution - 0315
state: HH
city: Hildesheim
country: Germany
facility: Local Institution - 0313
state: NI
city: Chemnitz
country: Germany
facility: Local Institution - 0316
state: SN
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Gottingen
country: Germany
facility: Local Institution - 0310
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE)
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm-Heessen GmbH
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Marburg
country: Germany
facility: Local Institution - 0323
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
state: B
city: Rio
country: Greece
facility: University of Patras - Rio Regional University Hospital
state: G
city: Athina
country: Greece
facility: Evangelismos General Hospital of Athens
state: I
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
city: Larisa
country: Greece
facility: University of Thessaly- General University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Theageneio Cancer Hospital of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
state: HK
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ III. sz. Belgyógyászati Klinika
state: HB
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research (PGIMER)
state: CH
city: Bangalore
country: India
facility: HCG Cancer Center - Kalinga Rao Road
state: Karnataka
city: Cochin
country: India
facility: Aster Medcity
state: KL
city: Kolhapur
country: India
facility: Dr. Bafnas Star Superspecaility Clinic and Hospital
state: MH
city: Nagpur
country: India
facility: Alexis Multispeciality Hospital
state: MH
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Center
state: MH
city: Pune
country: India
facility: Sahyadri Speciality Hospital Deccan Gymkhana
state: MH
city: Bhubaneswar
country: India
facility: Sparsh Hospitals & Critical Care
state: Odisha
city: Kolkata
country: India
facility: Tata Medical Center
state: WB
city: Navi Mumbai
country: India
facility: Local Institution - 0135
city: Ashdod
country: Israel
facility: Assuta Medical Center
city: Beer Ya'Aqov
country: Israel
facility: Assaf Harofeh Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Davidoff Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv-Yafo
country: Israel
facility: Local Institution - 0136
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
state: CT
city: Firenze
country: Italy
facility: Local Institution - 0306
state: FI
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
state: GE
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: MI
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: MI
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
state: PI
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: RM
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
state: TO
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Shibukawa-shi
country: Japan
facility: National Hospital Organization (NHO) - Shibukawa Medical Center
state: Gunma
city: Kamakura-Shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
city: Gifu-Shi
country: Japan
facility: Gifu Municipal Hospital
city: Higashiibaraki-Gun
country: Japan
facility: Local Institution - 0133
city: Hiroshima-shi
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
city: Isehara-shi
country: Japan
facility: Tokai University Hospital IRB
city: Kagoshima-Shi
country: Japan
facility: Kagoshima University Hospital
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
city: Kobe-Shi
country: Japan
facility: Local Institution - 0134
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR)
city: Maebashi-Shi
country: Japan
facility: Gunma University Hospital
city: Minato-Ku
country: Japan
facility: The Jikei University Hospital
city: Nagasaki-Shi
country: Japan
facility: The Japanese Red Cross Nagasaki Genbaku Hospital
city: Nagoya-Shi
country: Japan
facility: Nagoya City University Hospital
city: Osakasayama-Shi
country: Japan
facility: Kindai University Hospital
city: Saitama-shi
country: Japan
facility: Jichi Medical University Saitama Medical Center
city: Sapporo-shi
country: Japan
facility: Sapporo Hokuyu Hospital
city: Sendai-shi
country: Japan
facility: National Hospital Organization Sendai Medical Center
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital (UUH)
city: Mexico
country: Mexico
facility: Local Institution - 0127
state: CMX
city: Toluca De Lerdo
country: Mexico
facility: Local Institution - 0146
state: MEX
city: Monterrey
country: Mexico
facility: Local Institution - 0283
state: NL
city: Mexico city
country: Mexico
facility: Local Institution - 0107
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: NH
city: Almere
country: Netherlands
facility: Local Institution - 0325
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital - Locatie Dordwijk
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr. 2 im Dr. Jana Biziela w Bydgoszczy
state: KP
city: Lodz
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
state: LD
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: PM
city: Gliwice
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Lublin
country: Poland
facility: Office of Dr n. Med. Wojciech Legiec
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
city: Braga
country: Portugal
facility: Unidade Local de Saude Braga
city: Coimbra
country: Portugal
facility: Unidade Local de Saude de Coimbra, EPE - Hospitais da Universidade de Coimbra
city: Porto
country: Portugal
facility: Instituto Português Oncologia do Porto Francisco Gentil, EPE
city: Bucureşti
country: Romania
facility: Institutul Clinic Fundeni
state: B
city: Craiova
country: Romania
facility: Spitalul Clinic Municipal Filantropia Craiova
state: Dolj
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iași
state: IS
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
state: Jud. Cluj
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
city: Singapore
country: Singapore
facility: National University Hospital (S) Pte Ltd
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: B
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
state: CC
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: Las Palmas
city: Murcia
country: Spain
facility: Hospital Universitario Virgen Arrixaca
state: MU
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
state: VC
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra -Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Luleå
country: Sweden
facility: Local Institution - 0171
state: BD
city: Borås
country: Sweden
facility: Södra Älvsborgs Sjukhus
city: Uddevalla
country: Sweden
facility: Vastra Goetalandsregionen - Uddevalla Sjukhus (US)
city: Aarau 1
country: Switzerland
facility: Local Institution - 0168
city: Kao-Hsiung
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung Branch
city: Kaohsiung
country: Taiwan
facility: E-DA Cancer Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Cankaya
country: Turkey
facility: Liv Hospital Ankara
city: Edirne
country: Turkey
facility: Trakya Üniversitesi Tıp Fakültesi
city: Istanbul
country: Turkey
facility: Local Institution - 0068
city: Istanbul
country: Turkey
facility: T.C. Istanbul Bilim Universitesi - lstanbul Florence Nightingale Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital)
city: Izmir
country: Turkey
facility: Local Institution - 0073
city: Kayseri
country: Turkey
facility: Erciyes Üniversitesi Tıp Fakültesi
city: Yenimahalle
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
city: Aberdeen
country: United Kingdom
facility: NHS Grampian - Aberdeen Royal Infirmary
state: ABD
city: Windsor
country: United Kingdom
facility: GenesisCare -Windosr
state: Berkshire
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
state: DBY
city: Bournemouth
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust (UHD) - Royal Bournemouth Hospital (RBH)
state: DOR
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
state: HAM
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust (UHNM) - Royal Stoke University Hospital
state: Staffordshire
city: Edinburgh
country: United Kingdom
facility: NHS Lothian - Western General Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St Bartholomew's Hospital
city: Oxford
country: United Kingdom
facility: GenesisCare-Oxford
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: