A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
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)
3 other identifiers
interventional
1,230
33 countries
267
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).
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 Jun 2023
Longer than P75 for phase_3 multiple-myeloma
267 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
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedStudy Start
First participant enrolled
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2036
July 2, 2026
June 1, 2026
5.7 years
April 11, 2023
July 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Up to 6 years
Secondary Outcomes (17)
Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment
Up to 6 years
Overall Survival
Up to 12 years
Recommended iberdomide dose for Stage 2
Up to 1 year
Area under the iberdomide plasma concentration-time curve from time zero to tau
Up to 1 year
Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)
Up to 1 year
- +12 more secondary outcomes
Study Arms (4)
Arm A1: Iberdomide Dose 1
EXPERIMENTALArm A2: Iberdomide Dose 2
EXPERIMENTALArm A3: Iberdomide Dose 3
EXPERIMENTALArm B: Lenalidomide
ACTIVE COMPARATORInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (271)
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012-5405, United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida, 32224-1865, United States
Local Institution - 0308
Tampa, Florida, 33606, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612-9416, United States
Cleveland Clinic
Weston, Florida, 33331-3609, United States
University Cancer & Blood Center
Athens, Georgia, 30607-1465, United States
The Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322-1013, United States
Augusta University - Georgia Cancer Center
Augusta, Georgia, 30912, United States
Local Institution - 0237
Chicago, Illinois, 60637-1426, United States
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas, 66205-2003, United States
Maryland Oncology Hematology, PA- Clinton
Clinton, Maryland, 20735-4230, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan - Rogel Cancer Center
Ann Arbor, Michigan, 48109-5000, United States
Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit
Detroit, Michigan, 48202-2610, United States
Cancer & Hematology Centers of Western Michigan (CHCWM)
Grand Rapids, Michigan, 49503, United States
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, 55905, United States
Hattiesburg Clinic - Hematology & Oncology
Hattiesburg, Mississippi, 39401, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Perlmutter Cancer Center - Sunset Park
Brooklyn, New York, 11220-3313, United States
Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York, 11501, United States
NYU Langone Health
New York, New York, 10016-6402, United States
Columbia University Medical Center - Herbert Irving Pavilion Location
New York, New York, 10032-3729, United States
Optum Medical Care PC
Westbury, New York, 11590-5119, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina, 28803-2493, United States
Duke University Hospital
Durham, North Carolina, 27705-3976, United States
Novant Health Cancer Institute Hematology - Forsyth
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd
Cincinnati, Ohio, 45236-2725, United States
Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)
Cleveland, Ohio, 44111, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Midwest Oncology Associates - Kansas City
Kansas, Ohio, 64132, United States
Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center
Mayfield Heights, Ohio, 44124, United States
Local Institution - 0013
Toledo, Ohio, 43623, United States
Wooster Milltown Specialty and Surgery Center
Wooster, Ohio, 44691, United States
Willamette Valley Cancer Institute
Eugene, Oregon, 97401, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center - Jeanes Campus
Philadelphia, Pennsylvania, 19111-2433, United States
Local Institution - 0253
Pittsburgh, Pennsylvania, 15232, United States
West Cancer Center
Germantown, Tennessee, 38138-1762, United States
Local Institution - 0004
Nashville, Tennessee, 37203-1625, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, 75390-0001, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina
"Centro de Educación Médica e Investigaciones Clínicas ""Norberto Quirno"""
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., C1430EFA, Argentina
Hospital Universitario Austral
Pilar, B, B1629AHJ, Argentina
Sanatorio Allende
Córdoba, X5000JHGQ, Argentina
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Health
Clayton, Victoria, 3800, Australia
Ordensklinikum Linz Elisabethinen
Linz, 4020, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100, Austria
Medizinische Universitaet Wien - Universitaetsklinik fuer Augenheilkunde und Optometrie
Vienna, 1090, Austria
Hanusch-Krankenhaus
Vienna, 1140, Austria
Grand Hopital de Charleroi - Les Viviers
Charleroi, WHT, 6060, Belgium
AZ Groeninge - Campus Kennedylaan
Kortrijk, 8500, Belgium
CHN - Complexo Hospitalar de Niteroi
Niterói, Rio de Janeiro, 24020-096, Brazil
Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14051-140, Brazil
Clinica Medica Sao Germano
São Paulo, São Paulo, 04537-080, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, 08270-070, Brazil
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, 14784-400, Brazil
Hospital Mãe de Deus
Porto Alegre, 90880-480, Brazil
Instituto COI de Pesquisa, Educação e Gestão
Rio de Janeiro, 21941-913, Brazil
Hospital São Rafael
Salvador, 40110-150, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution - 0208
Ottawa, Ontario, K1H 8L6, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
CHUQ - The Hôtel-Dieu de Québec
Québec, Quebec, Canada
Fundación Arturo López Pérez
Santiago, 7500691, Chile
Local Institution - 0258
Temuco, 4800827, Chile
Clinica Alemana - Vitacura
Vitacura, 7650567, Chile
Anhui Provincial Hospital
Hefei, AH, 230001, China
The Fifth Medical Center of People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100071, China
Local Institution - 0326
Beijing, BJ, 100038, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Local Institution - 0321
Chongqing, CQ, 400030, China
Nanfang Hospital of Southern Medical University
Guangzhou, GD, 510515, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518028, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The Third Xiangya Hospital of Central South University
Changsha, HN, 410013, China
Xiangya Hospital of Central South University
Changsha, HN, 410013, China
Nanjing Drum Tower Hospital - The Comprehensive Cancer Center
Nanjing, Jiangsu, 210008, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
The First Affiliated Hospital of Nanchang University - Donghu District
Nanchang, Jiangxi, 330200, China
The First Hospital of Jilin University
Changchun, JL, 130021, China
Local Institution - 0094
Shenyang, Liaoning, 110022, China
Qilu Hospital of Shandong University
Jinan, SD, 250012, China
The First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi, 710032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shanghai Fourth People's Hospital
Shanghai, SH, 200434, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, ZJ, 310003, China
The First Affiliated Hospital of Ningbo University
Ningbo, ZJ, 315010, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020, China
Peking University People's Hospital
Beijing, 100044, China
The Second Xiangya Hospital of Central South University
Changsha, 400011, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Sun Yat-sen University Cancer Center
Guangzhou, 511363, China
Shandong Provincial Hospital
Jinan, 250021, China
Jiangsu Province Hospital
Nanjing, 210029, China
Qingdao Municipal Hospital
Qingdao, 266071, China
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, 200025, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Wenzhou Medical University - The First Affiliated Hospital
Wenzhou, 325000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030, China
Oncomedica S.A.
Montería, COR, 230002, Colombia
Instituto Nacional de Cancerología - Bogota
Bogotá, 110111, Colombia
Fundacion Centro de Tratamiento e Investigacion sobre Cancer Luis Carlos Sarmiento Angulo - CTIC
Bogotá, 110131, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, 681004, Colombia
Hospital Pablo Tobon Uribe
Medellín, 050034, Colombia
Sociedad de Oncologia y Hematologia del Cesar S.A.S
Valledupar, 200001, Colombia
Local Institution - 0036
Brno, 625 00, Czechia
Fakultní Nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultní nemocnice Královské Vinohrady
Prague, 100 34, Czechia
Vseobecna Fakultni Nemocnice
Prague, 128 08, Czechia
Local Institution - 0028
Odense, 5000, Denmark
Helsingin Yliopistollinen Sairaala (HUS) - Syopakeskus (Comprehensive Cancer Center)
Helsinki, 00290, Finland
Kuopio University Hospital
Kuopio, 70211, Finland
CHU Hôpital Sud
Amiens, 80000, France
Institut d'Hématologie de Basse-Normandie (IHBN)
Caen, 14033, France
CHU Hôpital Henri Mondor
Créteil, 94000, France
Centre Hospitalier Départemental Vendée - Hôpital de la Roche-sur-Yon
La Roche-sur-Yon, 85000, France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille, 59037, France
CHU Limoges - Hôpital Dupuytren
Limoges, 87042, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, 44093, France
Hôpital Saint-Antoine
Paris, 75012, France
Hopital Pitie-Salpetriere
Paris, 75013, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059, France
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Klinikum Augsburg
Augsburg, Bavaria, 86156, Germany
Klinikum Bayreuth GmbH
Bayreuth, Bavaria, 95445, Germany
Universitaetsklinikum Erlangen - Medizinische Klinik 5
Erlangen, Bavaria, 91054, Germany
LMU Klinikum der Universitaet Muenchen - Campus Grosshadern - Transplantation
Munich, Bavaria, 81377, Germany
Carl-Thiem-Klinikum Cottbus GmbH
Cottbus, Brandenburg, 03048, Germany
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, 22763, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 09116, Germany
Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, State of Berlin, 12203, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Local Institution - 0297
Hamburg, 20246, Germany
St. Barbara-Klinik Hamm-Heessen GmbH
Hamm, 59073, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
"General Hospital of Thessaloniki ""G. Papanikolaou"""
Thessaloniki, B, 570 10, Greece
University of Patras - Rio Regional University Hospital
Rio, G, 265 04, Greece
Evangelismos General Hospital of Athens
Athens, I, 106 76, Greece
Alexandra General Hospital of Athens
Athens, 115 28, Greece
Local Institution - 0290
Larissa, 411 10, Greece
Theageneio Cancer Hospital of Thessaloniki
Thessaloniki, 546 39, Greece
Queen Mary Hospital
Hong Kong, HK, 999077, Hong Kong
Debreceni Egyetem Klinikai Központ III. sz. Belgyógyászati Klinika
Debrecen, HB, 4032, Hungary
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, Chandigarh, 160012, India
Local Institution - 0110
Bangalore, Karnataka, 560027, India
Aster Medcity
Kochi, Kerala, 68202, India
Dr. Bafnas Star Superspecaility Clinic and Hospital
Kolhāpur, Maharashtra, 416005, India
Alexis Multispeciality Hospital
Nagpur, Maharashtra, 440030, India
Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, 411 004, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Sparsh Hospitals & Critical Care
Bhubaneswar, Odisha, 751007, India
Tata Medical Center
Kolkata, West Bengal, 700160, India
Assuta Medical Center
Ashdod, 7747629, Israel
Assaf Harofeh Medical Center
Beer Ya'Aqov, 70300, Israel
Hillel Yaffe Medical Center
Hadera, 38100, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah University Medical Center
Jerusalem, 9112001, Israel
Rabin Medical Center - Davidoff Center
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
Catania, CT, 95123, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, FI, 50134, Italy
Ospedale Policlinico San Martino
Genova, GE, 16132, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, MI, 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162, Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
Pisa, PI, 56127, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, RM, 00168, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, TO, 10126, Italy
"Azienda Ospedaliera Universitaria ""Federico II"""
Naples, 80131, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Policlinico Umberto I
Rome, 00161, Italy
Local Institution - 0106
Shibukawa-shi, Gunma, 3770280, Japan
Local Institution - 0197
Kamakura-Shi, Kanagawa, 2478533, Japan
Local Institution - 0198
Kumamoto, Kumamoto, 860-8556, Japan
Local Institution - 0130
Sunto-gun, Shizuoka, 411-8777, Japan
Local Institution - 0141
Chiba, 260-8677, Japan
Local Institution - 0118
Gifu, 500-8513, Japan
Local Institution - 0133
Higashiibaraki-Gun, 311-3193, Japan
Local Institution - 0112
Hiroshima, 730-8619, Japan
Local Institution - 0199
Isehara-shi, 259-1193, Japan
Local Institution - 0330
Itabashi-Ku, 173-8610, Japan
Local Institution - 0111
Kagoshima, 890-8520, Japan
Local Institution - 0144
Kanazawa, 920-8641, Japan
Local Institution - 0134
Kobe, 650-0047, Japan
Local Institution - 0122
Kōtoku, 135-8550, Japan
Local Institution - 0121
Maebashi, 371-8511, Japan
Local Institution - 0150
Minatoku, 105-8471, Japan
Local Institution - 0104
Nagasaki, 852-8511, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
Local Institution - 0329
Nerima-Ku, 179-0072, Japan
Local Institution - 0148
Saitama-Shi, 330-0834, Japan
Local Institution - 0268
Sakaishi, 590-0197, Japan
Local Institution - 0105
Sapporo, 003-0006, Japan
Local Institution - 0132
Sendai, 983-8520, Japan
Japanese Red Cross Medical Center
Shibuya-ku, 150-8935, Japan
"Universidad Autonoma de Nuevo Leon - Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"""
Monterrey, Nuevo León, 64460, Mexico
Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca
Toluca, State of Mexico, 50090, Mexico
VU University Medical Center
Amsterdam, North Holland, 1081 HV, Netherlands
Albert Schweitzer Hospital - Locatie Dordwijk
Dordrecht, 3300 AK, Netherlands
Szpital Uniwersytecki Nr. 2 im Dr. Jana Biziela w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Local Institution - 0327
Bydgoszcz, 85-048, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
Gliwice, 44-102, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Office of Dr n. Med. Wojciech Legiec
Lublin, 20-134, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, Łódź Voivodeship, 93-510, Poland
Unidade Local de Saude Braga
Braga, 4710-243, Portugal
Unidade Local de Saude de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Instituto Português Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Institutul Clinic Fundeni
Bucharest, B, 022328, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, Dolj, 200143, Romania
Institutul Regional de Oncologie Iași
Iași, IS, 700483, Romania
"Institutul Oncologic ""Prof. Dr. Ion Chiricuţă"" Cluj Napoca"
Cluj-Napoca, Jud. Cluj, 400015, Romania
"Institutul Oncologic ""Prof. Dr. Ion Chiricuţă"" Cluj Napoca"
Cluj-Napoca, 400015, Romania
National University Hospital (S) Pte Ltd
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Pusan National University Hospital
Busan, 49241, South Korea
National Cancer Center
Goyang-si, 410-769, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Yonsei University Health System, Severance Hospital
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ulsan University Hospital (UUH)
Ulsan, 44033, South Korea
Hospital Clínic de Barcelona
Barcelona, B, 08036, Spain
Hospital San Pedro de Alcántara
Cáceres, CC, 10003, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
Hospital Universitario Virgen Arrixaca
Murcia, MU, 30120, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitari i Politècnic La Fe
Valencia, VC, 46026, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Clínica Universidad de Navarra -Madrid
Madrid, 28022, Spain
Hospital Universitari Son Espases
Palma de Mallorca, 07120, Spain
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Södra Älvsborgs Sjukhus
Borås, 501 82, Sweden
Vastra Goetalandsregionen - Uddevalla Sjukhus (US)
Uddevalla, 451 51, Sweden
E-DA Cancer Hospital
Kaohsiung City, 82445, Taiwan
Chang Gung Medical Foundation - Kaohsiung Branch
Kaohsiung City, 83301, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
Ankara Bilkent City Hospital
Ankara, 06230, Turkey (Türkiye)
Liv Hospital Ankara
Çankaya, 06680, Turkey (Türkiye)
Trakya Üniversitesi Tıp Fakültesi
Edirne, 22030, Turkey (Türkiye)
T.C. Istanbul Bilim Universitesi - lstanbul Florence Nightingale Hastanesi
Istanbul, 34381, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital)
Izmir, 35100, Turkey (Türkiye)
Medical Point İzmir Hastanesi
Izmir, 35575, Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi
Kayseri, 38039, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Yenimahalle, 06200, Turkey (Türkiye)
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, ABD, AB25 2ZN, United Kingdom
GenesisCare -Windosr
Windsor, Berkshire, SL4 3HD, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
Derby, DBY, DE22 3NE, United Kingdom
University Hospitals Dorset NHS Foundation Trust (UHD) - Royal Bournemouth Hospital (RBH)
Bournemouth, DOR, BH7 7DW, United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
Portsmouth, HAM, PO6 3LY, United Kingdom
University Hospitals of North Midlands NHS Trust (UHNM) - Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
NHS Lothian - Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
London, W1G 6AF, United Kingdom
GenesisCare-Oxford
Oxford, OX4 6LB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
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
April 11, 2023
First Posted
April 24, 2023
Study Start
June 22, 2023
Primary Completion (Estimated)
March 15, 2029
Study Completion (Estimated)
January 1, 2036
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html