ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

PHASE3RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

October 24, 2023

Primary Completion Date

June 25, 2027

Study Completion Date

March 11, 2030

Conditions
Myelodysplastic Syndromes
Interventions
BIOLOGICAL

Luspatercept

Specified dose on specified days

BIOLOGICAL

Epoetin Alfa

Specified dose on specified days

Trial Locations (169)

0

WITHDRAWN

Local Institution - 0034, Hksar

1088

RECRUITING

Semmelweis Egyetem, Budapest

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

2148

RECRUITING

Blacktown Hospital, Blacktown

2450

RECRUITING

Coffs Harbour Health Campus, Coffs Harbour

3084

RECRUITING

Austin Health, Heidelberg

3168

RECRUITING

Monash Health, Clayton

3300

RECRUITING

Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet, Eger

4217

RECRUITING

Pindara Private Hospital, Gold Coast

4400

RECRUITING

Szabolcs Szatmár Bereg Vármegyei Oktatókórház, Nyíregyháza

10117

RECRUITING

Praxis fur Hamatologie und Onkologie, Berlin

10128

RECRUITING

Azienda Ospedaliera Ordine Mauriziano di Torino, Turin

11527

RECRUITING

"General Hospital of Athens Laiko", Athens

12462

RECRUITING

Attikon General University Hospital, Chaïdári

12808

RECRUITING

Vseobecna fakultni nemocnice v Praze, Prague

14080

RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City

14195

COMPLETED

Local Institution - 0028, Berlin

18012

RECRUITING

Hospital Universitario Virgen Nieves, Granada

20089

RECRUITING

Humanitas, Rozzano

20122

RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

20162

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milan

20817

RECRUITING

American Oncology Partners, PA, Bethesda

23219

RECRUITING

VCU Health Adult Outpatient Pavillion, Richmond

23562

NOT_YET_RECRUITING

Local Institution - 0255, Lübeck

24014

RECRUITING

Blue Ridge Cancer Care, Roanoke

26504

WITHDRAWN

Local Institution - 0242, Pátrai

RECRUITING

University Hospital of Patras, Pátrai

28006

RECRUITING

Hospital La Princesa, Madrid

31100

RECRUITING

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE, Toulouse

32114

NOT_YET_RECRUITING

Halifax Health Medical Center, Daytona Beach

WITHDRAWN

Local Institution - 0230, Daytona Beach

32207

RECRUITING

Baptist MD Anderson Cancer Center, Jacksonville

32500

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

33011

RECRUITING

Hospital Universitario Central de Asturias, Oviedo

33063

RECRUITING

D&H Cancer Research Center LLC, Margate

33321

RECRUITING

Advanced Research, Tamarac

33322

RECRUITING

BRCR Global, Plantation

33600

RECRUITING

CHU Bordeaux Haut-Leveque, Pessac

33612

RECRUITING

Moffitt Cancer Center, Tampa

33705

RECRUITING

Florida Cancer Specialists - North, St. Petersburg

33901

RECRUITING

Florida Cancer Specialists - South, Fort Myers

37007

RECRUITING

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca, Salamanca

37032

RECRUITING

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau, Tours

37134

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma, Verona

37920

RECRUITING

University of Tennessee Medical Center, Knoxville

38700

RECRUITING

Chu Grenoble Alpes, La Tronche

39401

RECRUITING

Hattiesburg Clinic Hematology/Oncology, Hattiesburg

40138

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna

40225

RECRUITING

Universitaetsklinikum Duesseldorf, Düsseldorf

41013

RECRUITING

Hospital Universitario Virgen Del Rocio, Seville

41501

WITHDRAWN

Local Institution - 0232, Pikeville

43210

RECRUITING

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus

46010

RECRUITING

Hospital Clinico de Valencia, Valencia

46311

RECRUITING

Northwest Cancer Centers, P.C., Dyer

48153

RECRUITING

Gemeinschaftspraxis für Hämatologie und Onkologie Münster, Münster

49933

RECRUITING

Centre Hospitalier Universitaire d'Angers, Angers

50134

RECRUITING

Azienda Ospedaliera Universitaria Careggi, Florence

52787

RECRUITING

Hematológica Alta Especialidad SC, consultorio 830, Huixquilucan

54511

RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois, Vandœuvre-lès-Nancy

55426

RECRUITING

Metro-Minnesota Community Clinical Oncology, Saint Louis Park

56068

RECRUITING

InVO Institut für Versorgungsforschung in der Onkologie, Koblenz

60077

RECRUITING

Orchard Healthcare Research Inc., Skokie

60611

RECRUITING

Northwestern Memorial Hospital, Chicago

68020

RECRUITING

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

70112

WITHDRAWN

Local Institution - 0097, New Orleans

70433

RECRUITING

Pontchartrain Cancer Center, Covington

70808

RECRUITING

Our Lady of the Lake RMC, Baton Rouge

72424

RECRUITING

Unidad Médica Onco-hematológica, Puebla City

73557

RECRUITING

Kliniken Ostalb, Stauferklinikum, Mutlangen

75010

RECRUITING

Hôpital Saint-Louis, Paris

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

80528

WITHDRAWN

Local Institution - 0098, Fort Collins

85435

RECRUITING

Onkologie Erding, Erding

87439

WITHDRAWN

Local Institution - 0250, Kempten (Allgäu)

89133

RECRUITING

Grande Ospedale Metropolitano - Presidio Morelli, Reggio Calabria

90095

RECRUITING

UCLA Hematology/Oncology - Westwood (Building 200 Suite 120), Los Angeles

90720

RECRUITING

Cancer and Blood Specialty Clinic, Los Alamitos

92708

RECRUITING

Compassionate Cancer Care Medical Group, Fountain Valley

92868

RECRUITING

St. Joseph Hospital, Orange

93030

RECRUITING

Ventura County Hematology Oncology Specialists, Oxnard

93611

RECRUITING

Community Cancer Institute, Clovis

93703

WITHDRAWN

Local Institution - 0095, Fresno

94598

RECRUITING

John Muir Health - Behring Pavilion, Walnut Creek

94805

RECRUITING

Gustave Roussy, Villejuif

96813

NOT_YET_RECRUITING

Local Institution - 0240, Honolulu

97080

RECRUITING

Gemeinschaftspraxis Dres. med. Björn Schöttker & Dominik Pretscher, Würzburg

98133

WITHDRAWN

Local Institution - 0213, Seattle

99336

RECRUITING

Kadlec Clinic Hematology and Oncology, Kennewick

100044

RECRUITING

Peking University People's Hospital, Beijing

100730

RECRUITING

Beijing Peking Union Medical College Hospital, Beijing

110001

RECRUITING

The First Hospital of China Medical University, Shenyang

110029

RECRUITING

All India Institute of Medical Sciences, New Delhi

WITHDRAWN

Local Institution - 0186, New Delhi

110085

RECRUITING

Rajiv Gandhi Cancer Institute And Research Centre, New Delhi

130021

COMPLETED

Local Institution - 0043, Changchun

150010

RECRUITING

The First Hospital of Harbin, Harbin

200001

RECRUITING

Sociedad De Oncologia Y Hematologia Del Cesar, Valledupar

200030

RECRUITING

Shanghai Sixth People's Hospital, Shanghai

210029

RECRUITING

Jiangsu Province Hospital, Nanjing

215006

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

230001

ACTIVE_NOT_RECRUITING

Local Institution - 0109, Hefei

230002

RECRUITING

Oncomédica S.A.S, Montería

266003

RECRUITING

The Affiliated Hospital of Qingdao University, Qingdao

300020

RECRUITING

Institute of hematology&blood disease hospital, Tianjin

310003

RECRUITING

The first Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

315010

NOT_YET_RECRUITING

Local Institution - 0281, Ningbo

330006

RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

350001

WITHDRAWN

Local Institution - 0096, Fuzhou Fujian

361003

COMPLETED

Local Institution - 0220, Xiamen

380009

RECRUITING

Hemato Oncology Clinic, Ahmedabad

382428

WITHDRAWN

Local Institution - 0273, Ahmedabad

400016

COMPLETED

Local Institution - 0223, Chongqing

410008

RECRUITING

Xiangya Hospital Central South University, Changsha

430058

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

450003

RECRUITING

People's Hospital of Henan Province, Zhengzhou

450008

WITHDRAWN

Local Institution - 0031, Guangzhou

500034

WITHDRAWN

Local Institution - 0185, Hyderabad

560027

NOT_YET_RECRUITING

Local Institution - 0177, Bengaluru

610041

COMPLETED

Local Institution - 0075, Chengdu

681017

RECRUITING

Fundación Cardiovascular de Colombia, Piedecuesta

710068

RECRUITING

Shaanxi provincial people's hospital, Xi’an

751003

RECRUITING

Institute of Medical Sciences and Sum Hospital, Bhubaneswar

7500587

RECRUITING

Enroll SpA, Santiago

7500921

RECRUITING

FALP, Santiago

7580206

RECRUITING

Clínica Inmunocel, Santiago

8068501

WITHDRAWN

Local Institution - 0123, Kitakyushu-shi

8420383

RECRUITING

Bradfordhill, Santiago

06102

RECRUITING

Hartford Hospital (HH), Hartford

06510

RECRUITING

Yale-New Haven Hospital, New Haven

07601

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

C1425DND

RECRUITING

Centro Medico Barrio Parque, Buenos Aires

C1426ANZ

RECRUITING

Instituto Alexander Fleming, Buenos Aires

CP1280AEB

RECRUITING

Hospital Británico de Buenos Aires, Buenos Aires

60430-270

RECRUITING

Hospital Universitario Walter Cantidio, Fortaleza

90610-000

RECRUITING

Hospital São Lucas da PUCRS, Porto Alegre

20211-030

RECRUITING

HEMORIO, Rio de Janeiro

05403-000

RECRUITING

Hospital das Clinicas FMUSP, São Paulo

T2N 5G2

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre, Calgary

V6Z 1Y6

RECRUITING

St. Paul's Hospital, Vancouver

N6A 5W9

RECRUITING

Victoria Hospital & Children's Hospital - London Health Sciences Centre, London

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

050000

RECRUITING

The Second Afilliated Hospital of Hebei Medical University, Shijiazhuang

05034

RECRUITING

Hospital Pablo Tobon Uribe, Medellín

625 00

RECRUITING

Fakultní nemocnice Brno Bohunice, Brno

708 52

RECRUITING

Fakultni nemocnice Ostrava, Ostrava

06202

RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet, Nice

04103

RECRUITING

Universitätsklinikum Leipzig, Leipzig

07747

RECRUITING

Universitätsklinikum Jena, Jena

681 00

RECRUITING

University General Hospital of Alexandroupoli, Alexandroupoli

115 27

RECRUITING

"General Hospital of Athens G. Gennimatas", Athens

00133

RECRUITING

Fondazione Policlinico Tor Vergata, Rome

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma

064-0804

WITHDRAWN

Local Institution - 0117, Sapporo

660-8550

WITHDRAWN

Local Institution - 0126, Amagasaki

252-0375

WITHDRAWN

Local Institution - 0120, Sagamihara

980-8574

WITHDRAWN

Local Institution - 0118, Sendai

589-8511

WITHDRAWN

Local Institution - 0125, Ōsaka-sayama

321-0293

WITHDRAWN

Local Institution - 0121, Shimotsuga

852-8104

WITHDRAWN

Local Institution - 0124, Nagasaki

545-8586

WITHDRAWN

Local Institution - 0122, Osaka

141-8625

WITHDRAWN

Local Institution - 0119, Tokyo

58-309

RECRUITING

Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu, Wałbrzych

80-952

RECRUITING

Uniwersyteckie Centrum Kliniczne, Gdansk

40-519

RECRUITING

Pratia Onkologia Katowice, Katowice

02-172

RECRUITING

MTZ Clinical Research powered by Pratia, Warsaw

00917

RECRUITING

Auxilio Mutuo Cancer Center, San Juan

WITHDRAWN

Local Institution - 0237, San Juan

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08908

RECRUITING

Institut Català d'Oncologia - L'Hospitalet, L'Hospitalet de Llobregat

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT05949684 - ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions | Biotech Hunter | Biotech Hunter