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ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
Sponsor: Bristol-Myers Squibb
Summary
The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).
Official title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2023-10-24
Completion Date
2030-03-11
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Luspatercept
Specified dose on specified days
Epoetin Alfa
Specified dose on specified days
Locations (169)
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
Local Institution - 0224
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
Royal Prince Alfred Hospital
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
Local Institution - 0217
Beijing, Beijing Municipality, China
Local Institution - 0030
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
Local Institution - 0266
Shijiazhuang, Hebei, China
Local Institution - 0038
Harbin, Heilongjiang, China
Local Institution - 0194
Zhengzhou, Henan, China
Local Institution - 0108
Wuhan, Hubei, China
Local Institution - 0089
Changsha, Hunan, China
Local Institution - 0032
Nanjing, Jiangsu, China
Local Institution - 0083
Suzhou, Jiangsu, China
Local Institution - 0079
Nanchang, Jiangxi, China
Local Institution - 0043
Changchun, Jilin, China
Local Institution - 0048
Shenyang, Liaoning, China
Local Institution - 0111
Qingdao, Shandong, China
Local Institution - 0218
Shanghai, Shanghai Municipality, China
Local Institution - 0216
Xi’an, Shanxi, China
Local Institution - 0075
Chengdu, Sichuan, China
Local Institution - 0103
Tianjin, Tianjin Municipality, China
Local Institution - 0029
Hangzhou, Zhejiang, China
Local Institution - 0281
Ningbo, Zhejiang, China
Local Institution - 0033
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
Instituto Médico de Alta Tecnología S.A.S - IMAT 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
Local Institution - 0243
Ahmedabad, Gujarat, India
Local Institution - 0273
Ahmedabad, Gujarat, India
Local Institution - 0177
Bengaluru, Karnataka, India
Local Institution - 0193
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0235
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0178
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
Hospital Universitario Virgen Del Rocio
Seville, Spain