ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
NCT ID: NCT05949684
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2023-10-24
2030-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Luspatercept
Luspatercept
Specified dose on specified days
Epoetin Alfa
Epoetin Alfa
Specified dose on specified days
Interventions
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Luspatercept
Specified dose on specified days
Epoetin Alfa
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood.
* Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
* Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.
* Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
* Participant has symptoms of anemia:.
i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.
* Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.
Exclusion Criteria
* Participant with known history of diagnosis of AML.
* Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
* Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Hospital Universitario Virgen Del Rocio
Seville, , Spain
Community Cancer Institute
Clovis, California, United States
Compassionate Cancer Care Medical Group
Fountain Valley, California, United States
Local Institution - 0095
Fresno, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
Los Angeles, California, United States
St. Joseph Hospital
Orange, California, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, United States
John Muir Health - Behring Pavilion
Walnut Creek, California, United States
Local Institution - 0098
Fort Collins, Colorado, United States
Hartford Hospital (HH)
Hartford, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Halifax Health Medical Center
Daytona Beach, Florida, United States
Local Institution - 0230
Daytona Beach, Florida, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
BRCR Global
Plantation, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Advanced Research
Tamarac, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Local Institution - 0240
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Northwest Cancer Centers, P.C.
Dyer, Indiana, United States
Local Institution - 0232
Pikeville, Kentucky, United States
Our Lady of the Lake RMC
Baton Rouge, Louisiana, United States
Pontchartrain Cancer Center
Covington, Louisiana, United States
Local Institution - 0097
New Orleans, Louisiana, United States
American Oncology Partners, PA
Bethesda, Maryland, United States
Metro-Minnesota Community Clinical Oncology
Saint Louis Park, Minnesota, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Local Institution - 0213
Seattle, Washington, United States
Centro Medico Barrio Parque
Buenos Aires, , Argentina
Instituto Alexander Fleming
Buenos Aires, , Argentina
Hospital Británico de Buenos Aires
Buenos Aires, , Argentina
Blacktown Hospital
Blacktown, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Pindara Private Hospital
Gold Coast, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Hospital Universitario Walter Cantidio
Fortaleza, Ceará, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
HEMORIO
Rio de Janeiro, , Brazil
Hospital das Clinicas FMUSP
São Paulo, , Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Enroll SpA
Santiago, Santiago Metropolitan, Chile
FALP
Santiago, Santiago Metropolitan, Chile
Clínica Inmunocel
Santiago, Santiago Metropolitan, Chile
Bradfordhill
Santiago, Santiago Metropolitan, Chile
Local Institution - 0109
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Local Institution - 0223
Chongqing, Chongqing Municipality, China
Local Institution - 0096
Fuzhou Fujian, Fujian, China
Local Institution - 0220
Xiamen, Fujian, China
Local Institution - 0031
Guangzhou, Guangdong, China
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Hospital of Harbin
Harbin, Heilongjiang, China
People's Hospital of Henan Province
Zhengzhou, Henan, China
Local Institution - 0108
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Local Institution - 0043
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Shaanxi provincial people's hospital
Xi’an, Shanxi, China
Local Institution - 0075
Chengdu, Sichuan, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Local Institution - 0281
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar
Valledupar, Cesar Department, Colombia
Fundación Cardiovascular de Colombia
Piedecuesta, Santander Department, Colombia
Oncomédica S.A.S
Montería, , Colombia
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
Fakultni nemocnice Ostrava
Ostrava, Moravskoslezský kraj, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, Alpes-Maritimes, France
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours, Indre-et-Loire, France
Chu Grenoble Alpes
La Tronche, Isère, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Lorraine, France
Centre Hospitalier Universitaire d'Angers
Angers, Maine-et-Loire, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Hôpital Saint-Louis
Paris, , France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, , France
Local Institution - 0261
Erding, Bavaria, Germany
Local Institution - 0250
Kempten (Allgäu), Bavaria, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Münster
Münster, North Rhine-Westphalia, Germany
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, Rhineland-Palatinate, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Praxis fur Hamatologie und Onkologie
Berlin, , Germany
Local Institution - 0028
Berlin, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Local Institution - 0255
Lübeck, , Germany
Kliniken Ostalb, Stauferklinikum
Mutlangen, , Germany
Gemeinschaftspraxis Dres. med. Björn Schöttker & Dominik Pretscher
Würzburg, , Germany
Local Institution - 0242
Pátrai, Achaḯa, Greece
University Hospital of Patras
Pátrai, Achaḯa, Greece
University General Hospital of Alexandroupoli
Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece
General Hospital of Athens "G. Gennimatas"
Athens, Attikí, Greece
General Hospital of Athens "Laiko"
Athens, Attikí, Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece
Local Institution - 0034
Hksar, , Hong Kong
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet
Eger, Heves County, Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Hemato Oncology Clinic
Ahmedabad, Gujarat, India
Local Institution - 0273
Ahmedabad, Gujarat, India
Local Institution - 0177
Bengaluru, Karnataka, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, India
Institute of Medical Sciences and Sum Hospital
Bhubaneswar, Odisha, India
Local Institution - 0185
Hyderabad, , India
Local Institution - 0186
New Delhi, , India
Fondazione Policlinico Tor Vergata
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy
Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, , Italy
Grande Ospedale Metropolitano - Presidio Morelli
Reggio Calabria, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, , Italy
Local Institution - 0123
Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0117
Sapporo, Hokkaido, Japan
Local Institution - 0126
Amagasaki, Hyōgo, Japan
Local Institution - 0120
Sagamihara, Kanagawa, Japan
Local Institution - 0118
Sendai, Miyagi, Japan
Local Institution - 0125
Ōsaka-sayama, Osaka, Japan
Local Institution - 0121
Shimotsuga, Tochigi, Japan
Local Institution - 0124
Nagasaki, , Japan
Local Institution - 0122
Osaka, , Japan
Local Institution - 0119
Tokyo, , Japan
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, Mexico
Hematológica Alta Especialidad SC, consultorio 830
Huixquilucan, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, , Mexico
Unidad Médica Onco-hematológica
Puebla City, , Mexico
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych, Lower Silesian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
MTZ Clinical Research powered by Pratia
Warsaw, , Poland
Auxilio Mutuo Cancer Center
San Juan, , Puerto Rico
Local Institution - 0237
San Juan, , Puerto Rico
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen Nieves
Granada, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
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Role: CONTACT
Facility Contacts
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Haifaa Abdulhaq, Site 0070
Role: primary
Haresh Jhangiani, Site 0179
Role: primary
Vu Phan, Site 0211
Role: primary
Wanxing Chai-Ho, Site 0258
Role: primary
Timothy Byun, Site 0247
Role: primary
Lynn Kong, Site 0209
Role: primary
Gigi Chen, Site 0183
Role: primary
Devendra KC, Site 0227
Role: primary
Amer Zeidan, Site 0173
Role: primary
Ruby Anne Deveras, Site 0231
Role: primary
Syed Zafar, Site 0202
Role: primary
Maxim Norkin, Site 0180
Role: primary
David Kahn, Site 0224
Role: primary
Jason Tache, Site 0163
Role: primary
Gustavo Fonseca, Site 0201
Role: primary
Sumit Sawhney, Site 0238
Role: primary
Rami Komrokji, Site 0106
Role: primary
Site 0240
Role: primary
Yasmin Abaza, Site 0272
Role: primary
Ira Oliff, Site 0184
Role: primary
Shruti Singh, Site 0270
Role: primary
Marshall Stagg, Site 0191
Role: primary
David Oubre, Site 0044
Role: primary
Ralph Boccia, Site 0007
Role: primary
Yan Ji, Site 0222
Role: primary
John Hrom, Site 0128
Role: primary
Jamie Koprivnikar, Site 0212
Role: primary
Uma Borate, Site 0206
Role: primary
Wahid Hanna, Site 0174
Role: primary
Guillermo Garcia-Manero, Site 0228
Role: primary
Ruchi Desai, Site 0236
Role: primary
Amanda Gillespie-Twardy, Site 0229
Role: primary
Rangaswamy Chintapatla, Site 0203
Role: primary
Claudio Iastrebner, Site 0010
Role: primary
maria custidiano, Site 0009
Role: primary
Micaela Quarchioni, Site 0012
Role: primary
Kenny Tang, Site 0071
Role: primary
Stephen Larsen, Site 0113
Role: primary
Kyle Crassini, Site 0254
Role: primary
Hanlon Sia, Site 0246
Role: primary
Jake Shortt, Site 0054
Role: primary
Chun Fong, Site 0052
Role: primary
Silvia Maria Magalhaes, Site 0059
Role: primary
Mariza Schaan, Site 0101
Role: primary
Viviani Pessoa, Site 0056
Role: primary
Elvira Velloso, Site 0003
Role: primary
Michelle Geddes, Site 0049
Role: primary
Heather Leitch, Site 0112
Role: primary
lalit Saini, Site 0050
Role: primary
Rena Buckstein, Site 0017
Role: primary
Ximena Valladares, Site 0280
Role: primary
Valentina Goldschmidt, Site 0278
Role: primary
Alejandro Berkovits, Site 0276
Role: primary
Sergio Portiño, Site 0277
Role: primary
hongxia shi, Site 0217
Role: primary
Bing Han, Site 0030
Role: primary
Jinhai Ren, Site 0266
Role: primary
Tiejun Gong, Site 0038
Role: primary
zunmin zhu, Site 0194
Role: primary
Yajing Xu, Site 0089
Role: primary
Guangsheng He, Site 0032
Role: primary
Miao Miao, Site 0083
Role: primary
Fei Li, Site 0079
Role: primary
Xiaojing Yan, Site 0048
Role: primary
Wei Wang, Site 0111
Role: primary
Chunkang Chang, Site 0218
Role: primary
Yi WANG, Site 0216
Role: primary
zhijian xiao, Site 0103
Role: primary
Hongyan Tong, Site 0029
Role: primary
Site 0281
Role: primary
Sheng Luo, Site 0033
Role: primary
Kenny Galvez, Site 0147
Role: primary
Carmen Rosales, Site 0152
Role: primary
Jhon Avila Rueda, Site 0267
Role: primary
Leivi Correa Negrete, Site 0149
Role: primary
Jiri Mayer, Site 0080
Role: primary
Zdenek Koristek, Site 0092
Role: primary
Anna JONASOVA, Site 0090
Role: primary
Thomas Cluzeau, Site 0011
Role: primary
Sophie Dimicoli-Salazar, Site 0016
Role: primary
Emmanuel Gyan, Site 0019
Role: primary
Mathieu Meunier, Site 0116
Role: primary
Maud D'Aveni, Site 0165
Role: primary
sylvain thepot, Site 0269
Role: primary
Christophe WILLEKENS, Site 0248
Role: primary
Pierre FENAUX, Site 0015
Role: primary
Thibault Comont, Site 0140
Role: primary
Rüdiger Liersch, Site 0259
Role: primary
Rudolf Weide, Site 0168
Role: primary
Dominic Brauer, Site 0171
Role: primary
Carl Crodel, Site 0251
Role: primary
Stephan Fuhrmann, Site 0169
Role: primary
Ulrich Germing, Site 0207
Role: primary
Site 0255
Role: primary
Holger Hebart, Site 0167
Role: primary
Bjoern Schoettker, Site 0166
Role: primary
Alexandros Spyridonidis, Site 0132
Role: primary
IOANNIS KOTSIANIDIS, Site 0082
Role: primary
Eurydiki Michalis, Site 0084
Role: primary
Panagiotis Diamantopoulos, Site 0245
Role: primary
Vasiliki Pappa, Site 0131
Role: primary
Balazs Tajti, Site 0024
Role: primary
Laszlo Rejto, Site 0021
Role: primary
ZSOLT GYORGY Nagy, Site 0026
Role: primary
Sandip A. Shah, Site 0243
Role: primary
Site 0177
Role: primary
Tulika Seth, Site 0193
Role: primary
Dinesh Bhurani, Site 0235
Role: primary
Priyanka Samal, Site 0178
Role: primary
Maria Teresa Voso, Site 0256
Role: primary
Bruno Fattizzo, Site 0137
Role: primary
Marta Riva, Site 0134
Role: primary
Matteo Giovanni Della Porta, Site 0136
Role: primary
Daniela Cilloni, Site 0085
Role: primary
VALERIA SANTINI, Site 0138
Role: primary
Stefania Paolini, Site 0135
Role: primary
Caterina Alati, Site 0076
Role: primary
Luana Fianchi, Site 0244
Role: primary
Andrea Bernardelli, Site 0133
Role: primary
Gabriel Barragán Ibañez, Site 0156
Role: primary
Roberto Ovilla Martinez, Site 0069
Role: primary
María Demichelis, Site 0142
Role: primary
Xochiquetzatl Jimenez Lopez, Site 0150
Role: primary
Aleksandra Butrym, Site 0130
Role: primary
Ewa Zarzycka, Site 0060
Role: primary
Sebastian Grosicki, Site 0061
Role: primary
Krzysztof Madry, Site 0062
Role: primary
Adelba Torres Lopez, Site 0219
Role: primary
David Ferreiras, Site 0198
Role: primary
Montserrat Arnan Sangerman, Site 0197
Role: primary
Maria del Mar Tormo, Site 0196
Role: primary
Francisca Hernandez Mohedo, Site 0199
Role: primary
VALLE GOMEZ GARCIA DE SORIA, Site 0252
Role: primary
Teresa Bernal del Castillo, Site 0271
Role: primary
Maria Diez, Site 0200
Role: primary
Jose Falantes, Site 0274
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2022-500430-29-00
Identifier Type: OTHER
Identifier Source: secondary_id
CA056-025
Identifier Type: -
Identifier Source: org_study_id
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