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

June 18, 2024 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, CP1280AEB
        • Recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
      • Buenos Aires, Argentina, 1425
        • Recruiting
        • Centro Mdico "Barrio Parque"
        • Contact:
          • Claudio Iastrebner, Site 0010
          • Phone Number: +54-911-69816300
      • Ciudad Autónoma de Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Hospital
        • Contact:
          • Kenny Tang, Site 0071
          • Phone Number: 0286708421
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Stephen Larsen, Site 0113
          • Phone Number: +61 2 9515 8031
      • Coffs Harbour, New South Wales, Australia, 2450
        • Not yet recruiting
        • Local Institution - 0254
        • Contact:
          • Site 0254
    • Queensland
      • Gold Coast, Queensland, Australia, 4217
        • Not yet recruiting
        • Local Institution - 0246
        • Contact:
          • Site 0246
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
        • Contact:
          • Jake Shortt, Site 0054
          • Phone Number: +61412633726
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
          • Chun Fong, Site 0052
          • Phone Number: 61394966731
  • Brazil
      • Rio de Janeiro, Brazil, 20211-030
        • Recruiting
        • HEMORIO
        • Contact:
          • Viviani Pessoa, Site 0056
          • Phone Number: 21-981698808
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Hospital das Clinicas FMUSP
        • Contact:
          • Elvira Velloso, Site 0003
          • Phone Number: +551145737631
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-270
        • Recruiting
        • Hospital Universitario Walter Cantidio
        • Contact:
          • Silvia Maria Magalhaes, Site 0059
          • Phone Number: 85999818108
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Recruiting
        • Hospital São Lucas da PUCRS
        • Contact:
          • Mariza Schaan, Site 0101
          • Phone Number: 55 5133203319
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Center
        • Contact:
          • Michelle Geddes, Site 0049
          • Phone Number: 4039448047
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Not yet recruiting
        • Local Institution - 0112
        • Contact:
          • Site 0112
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Victoria Hospital & Children's Hospital - London Health Sciences Centre
        • Contact:
          • lalit Saini, Site 0050
          • Phone Number: 519-685-8500x56072
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
          • Rena Buckstein, Site 0017
          • Phone Number: 4163992979
  • China
    • Anhui
      • Hefei, Anhui, China, 230071
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
          • Baolin Tang, Site 0109
          • Phone Number: 13856901277
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • hongxia shi, Site 0217
          • Phone Number: 13661049635
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Peking Union Medical College Hospital
        • Contact:
          • Bing Han, Site 0030
          • Phone Number: 8613601059938
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • li wang, Site 0223
          • Phone Number: 18623015252
    • Fujian
      • Fuzhou Fujian, Fujian, China, 350001
        • Withdrawn
        • Local Institution - 0096
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University
        • Contact:
          • bing xu, Site 0220
          • Phone Number: 18750918842
    • Guangdong
      • Guangzhou, Guangdong, China, 450008
        • Withdrawn
        • Local Institution - 0031
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150010
        • Recruiting
        • The First Hospital of Harbin
        • Contact:
          • Tiejun Gong, Site 0038
          • Phone Number: 13836027737
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • People's Hospital of Henan Province
        • Contact:
          • zunmin zhu, Site 0194
          • Phone Number: 13603712008
    • Hubei
      • Wuhan, Hubei, China, 430058
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Min Zhang, Site 0108
          • Phone Number: 15871818568
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Yajing Xu, Site 0089
          • Phone Number: 13875804518
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Guangsheng He, Site 0032
          • Phone Number: 8615312052798
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Fei Li, Site 0079
          • Phone Number: 13970038386
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • sujun gao, Site 0043
          • Phone Number: +86 15843073208
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Xiaojing Yan, Site 0048
          • Phone Number: 13889128302
    • Shaanxi
      • Xian, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • Yi WANG, Site 0216
          • Phone Number: 13571936193
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Wei Wang, Site 0111
          • Phone Number: 18661807392
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Local Institution - 0218
        • Contact:
          • Site 0218
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Yu Wu, Site 0075
          • Phone Number: 18980601973
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Institute of hematology&blood disease hospital
        • Contact:
          • zhijian xiao, Site 0103
          • Phone Number: +86 13821085716
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Hongyan Tong, Site 0029
          • Phone Number: 13958122357
      • Wenzhou, Zhejiang, China, 32500
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Sheng Luo, Site 0033
          • Phone Number: +86 13957747543
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 05034
        • Not yet recruiting
        • Local Institution - 0147
        • Contact:
          • Site 0147
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Not yet recruiting
        • Local Institution - 0152
        • Contact:
          • Site 0152
    • Córdoba
      • Montería, Córdoba, Colombia, 230002
        • Not yet recruiting
        • Local Institution - 0149
        • Contact:
          • Site 0149
  • Czechia
      • Praha 2, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
        • Contact:
          • Anna JONASOVA, Site 0090
          • Phone Number: +420224966209
    • Brno-město
      • Brno, Brno-město, Czechia, 625 00
        • Not yet recruiting
        • Local Institution - 0080
        • Contact:
          • Site 0080
    • Moravskoslezský Kraj
      • Ostrava, Moravskoslezský Kraj, Czechia, 708 52
        • Recruiting
        • Fakultni Nemocnice Ostrava
        • Contact:
          • Zdenek Koristek, Site 0092
          • Phone Number: +420597374566
  • France
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
          • Pierre FENAUX, Site 0015
          • Phone Number: +33171207022
      • Toulouse, France, 31100
        • Recruiting
        • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
        • Contact:
          • Thibault Comont, Site 0140
          • Phone Number: 0033531156266
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
        • Contact:
          • Thomas Cluzeau, Site 0011
          • Phone Number: 33492039268
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Recruiting
        • CHU Bordeaux Haut-Leveque
        • Contact:
          • Sophie Dimicoli-Salazar, Site 0016
          • Phone Number: 33557656511
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37032
        • Not yet recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
    • Isère
      • La Tronche, Isère, France, 38700
        • Recruiting
        • Chu Grenoble Alpes
        • Contact:
          • Mathieu Meunier, Site 0116
          • Phone Number: 33476765755
    • Lorraine
      • Vandoeuvre lès Nancy, Lorraine, France, 54511
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
        • Contact:
          • Maud D'Aveni, Site 0165
          • Phone Number: 0609481716
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Not yet recruiting
        • Local Institution - 0248
        • Contact:
          • Site 0248
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Praxis fur Hamatologie und Onkologie
        • Contact:
          • Stephan Fuhrmann, Site 0169
          • Phone Number: +49(0)152 54777515
      • Berlin, Germany, 14195
        • Completed
        • Local Institution - 0028
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf
        • Contact:
          • Norbert Gattermann, Site 0207
          • Phone Number: 0211-81 16500
      • Lübeck, Germany, 23562
        • Not yet recruiting
        • Local Institution - 0255
        • Contact:
          • Site 0255
      • Mutlangen, Germany, 73557
        • Recruiting
        • Kliniken Ostalb, Stauferklinikum
        • Contact:
          • Holger Hebart, Site 0167
          • Phone Number: 4971717011302
      • Würzburg, Germany, 97080
        • Recruiting
        • Gemeinschaftspraxis Dr. med. Björn Schöttker & Dominik Pretscher
        • Contact:
          • Bjoern Schoettker, Site 0166
          • Phone Number: 0931322670
    • Bayern
      • Erding, Bayern, Germany, 85435
        • Not yet recruiting
        • Local Institution - 0261
        • Contact:
          • Site 0261
      • Kempten, Bayern, Germany, 87439
        • Withdrawn
        • Local Institution - 0250
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48153
        • Not yet recruiting
        • Local Institution - 0259
        • Contact:
          • Site 0259
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • Recruiting
        • Local Institution - 0168
        • Contact:
          • Site 0168
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig
        • Contact:
          • Dominic Brauer, Site 0171
          • Phone Number: 493419713859
    • Thüringen
      • Jena, Thüringen, Germany, 07747
        • Not yet recruiting
        • Local Institution - 0251
        • Contact:
          • Site 0251
  • Greece
      • Alexandroupolis, Greece, 08100
        • Recruiting
        • University Hospital of Alexandroupolis
        • Contact:
          • IOANNIS KOTSIANIDIS, Site 0082
          • Phone Number: +302551353739
    • Achaḯa
      • Patras, Achaḯa, Greece, 26504
        • Not yet recruiting
        • Local Institution - 0132
        • Contact:
          • Site 0132
      • Patras, Achaḯa, Greece, 26504
        • Withdrawn
        • Local Institution - 0242
    • Attikí
      • Athens, Attikí, Greece, 115 27
        • Recruiting
        • General Hospital of Athens "G. Gennimatas"
        • Contact:
          • Eurydiki Michalis, Site 0084
          • Phone Number: +306944452898
      • Chaidari, Attikí, Greece, 12462
        • Recruiting
        • Attikon General University Hospital
        • Contact:
          • Vasiliki Pappa, Site 0131
          • Phone Number: 00306937255084
  • Hungary
      • Budapest, Hungary, 1088
        • Recruiting
        • Semmelweis Egyetem
        • Contact:
          • ZSOLT GYORGY Nagy, Site 0026
          • Phone Number: 36208258660
    • Heves
      • Eger, Heves, Hungary, 3300
        • Recruiting
        • Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
        • Contact:
          • Balazs Tajti, Site 0024
          • Phone Number: 0036704223242
    • Szabolcs-Szatmár-Bereg
      • Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Recruiting
        • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
        • Contact:
          • Laszlo Rejto, Site 0021
          • Phone Number: 42599700
  • India
      • Hyderabad, India, 500034
        • Withdrawn
        • Local Institution - 0185
      • New Delhi, India, 110029
        • Withdrawn
        • Local Institution - 0186
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Not yet recruiting
        • Local Institution - 0193
        • Contact:
          • Site 0193
      • New Delhi, Delhi, India, 110085
        • Not yet recruiting
        • Local Institution - 0235
        • Contact:
          • Site 0235
    • Gujarat
      • Ahmedabad, Gujarat, India, 380009
        • Not yet recruiting
        • Local Institution - 0243
        • Contact:
          • Site 0243
    • Karnataka
      • Bengaluru, Karnataka, India, 560027
        • Not yet recruiting
        • Local Institution - 0177
        • Contact:
          • Site 0177
    • Odisha
      • Bhubaneswar, Odisha, India, 751003
        • Not yet recruiting
        • Local Institution - 0178
        • Contact:
          • Site 0178
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Contact:
          • Stefania Paolini, Site 0135
          • Phone Number: +393392231941
      • Reggio Calabria, Italy, 89133
        • Not yet recruiting
        • Local Institution - 0076
        • Contact:
          • Site 0076
      • Roma, Italy, 00168
        • Not yet recruiting
        • Local Institution - 0244
        • Contact:
          • Site 0244
      • Verona, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
        • Contact:
          • Andrea Bernardelli, Site 0133
          • Phone Number: 3272052368
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Not yet recruiting
        • Local Institution - 0256
        • Contact:
          • Site 0256
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
        • Contact:
          • Bruno Fattizzo, Site 0137
          • Phone Number: 02 55033477
    • Milano
      • Milan, Milano, Italy, 20162
        • Recruiting
        • Asst Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Marta Riva, Site 0134
          • Phone Number: 0264442668
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Humanitas
        • Contact:
          • Matteo Giovanni Della Porta, Site 0136
          • Phone Number: 0282247668
    • Piemonte
      • Torino, Piemonte, Italy, 10128
        • Recruiting
        • Azienda Ospedaliera Ordine Mauriziano di Torino
        • Contact:
          • Daniela Cilloni, Site 0085
          • Phone Number: +390115082224
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
          • VALERIA SANTINI, Site 0138
          • Phone Number: 0557947296
  • Mexico
      • Huixquilucan, Mexico, 52787
        • Recruiting
        • Hematológica Alta Especialidad SC, consultorio 830
        • Contact:
          • Roberto Ovilla Martinez, Site 0069
          • Phone Number: 5215521291399
      • Puebla, Mexico, 72424
        • Recruiting
        • Unidad Médica Onco-hematológica
        • Contact:
          • Xochiquetzatl Jimenez Lopez, Site 0150
          • Phone Number: 522222379880
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Not yet recruiting
        • Local Institution - 0142
        • Contact:
          • Site 0142
  • Poland
      • Gdańsk, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Contact:
          • Ewa Zarzycka, Site 0060
          • Phone Number: +48609803080
      • Katowice, Poland, 40-519
        • Recruiting
        • Pratia Onkologia Katowice
        • Contact:
          • Sebastian Grosicki, Site 0061
          • Phone Number: +48600388282
      • Warsaw, Poland, 02-172
        • Recruiting
        • Mtz Clinical Research powered by Pratia
        • Contact:
          • Krzysztof Madry, Site 0062
          • Phone Number: 485725959
    • Dolnośląskie
      • Wałbrzych, Dolnośląskie, Poland, 58-309
        • Recruiting
        • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
        • Contact:
          • Aleksandra Butrym, Site 0130
          • Phone Number: +48502657840
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Withdrawn
        • Local Institution - 0237
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • Auxilio Mutuo Cancer Center
        • Contact:
          • Adelba Torres Lopez, Site 0219
          • Phone Number: 7877582000
  • Spain
      • Granada, Spain, 18012
        • Recruiting
        • Local Institution - 0199
        • Contact:
          • Site 0199
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Local Institution - 0252
        • Contact:
          • Site 0252
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Maria Diez, Site 0200
          • Phone Number: 34699508223
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • David Ferreiras, Site 0198
          • Phone Number: 34934893000Ext6417
    • Catalunya [Cataluña]
      • L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet
        • Contact:
          • Montserrat Arnan Sangerman, Site 0197
          • Phone Number: 34932607750
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • Hospital Clínico de Valencia
        • Contact:
          • Maria del Tormo Diaz, Site 0196
          • Phone Number: +34961973838
  • United States
    • California
      • Clovis, California, United States, 93611
        • Recruiting
        • Community Cancer Institute
        • Contact:
          • Haifaa Abdulhaq, Site 0070
          • Phone Number: 559-618-6208
      • Concord, California, United States, 94520
        • Recruiting
        • John Muir Medical Center - Concord Campus
        • Contact:
          • Gigi Chen, Site 0183
          • Phone Number: 925-674-2580
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Compassionate Cancer Care Medical Group
        • Contact:
          • Haresh Jhangiani, Site 0179
          • Phone Number: 951-371-2411
      • Fresno, California, United States, 93703
        • Withdrawn
        • Local Institution - 0095
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Local Institution - 0247
        • Contact:
          • Site 0247
      • Oxnard, California, United States, 93030
        • Not yet recruiting
        • Ventura County Hematology Oncology Specialists
        • Contact:
          • Lynn Kong, Site 0209
          • Phone Number: 000-000-0000
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Withdrawn
        • Local Institution - 0098
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital (HH)
        • Contact:
          • Devendra KC, Site 0227
          • Phone Number: 860-972-5361
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital
        • Contact:
          • Amer Zeidan, Site 0173
          • Phone Number: 203-737-7078
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Not yet recruiting
        • Halifax Health Medical Center
        • Contact:
          • Ruby Anne Deveras, Site 0231
          • Phone Number: 386-254-4212
      • Daytona Beach, Florida, United States, 32114
        • Withdrawn
        • Local Institution - 0230
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists - South
        • Contact:
          • Syed Zafar, Site 0202
          • Phone Number: 239-274-9930
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
          • Maxim Norkin, Site 0180
          • Phone Number: 248-756-4524
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Cancer Research Center LLC
        • Contact:
          • David Kahn, Site 0224
          • Phone Number: 954-773-9890
      • Plantation, Florida, United States, 33322
        • Recruiting
        • BRCR Global
        • Contact:
          • Jason Tache, Site 0163
          • Phone Number: 516-447-0614
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists - North
        • Contact:
          • Gustavo Fonseca, Site 0201
          • Phone Number: 000-000-0000
      • Tamarac, Florida, United States, 33321
        • Not yet recruiting
        • Local Institution - 0238
        • Contact:
          • Site 0238
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Moffitt Cancer Center
        • Contact:
          • rami komrokji, Site 0106
          • Phone Number: 513-504-9712
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Not yet recruiting
        • Local Institution - 0240
        • Contact:
          • Site 0240
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Orchard Healthcare Research Inc.
        • Contact:
          • Ira Oliff, Site 0184
          • Phone Number: 224-534-7580
    • Kentucky
      • Pikeville, Kentucky, United States, 41501
        • Withdrawn
        • Local Institution - 0232
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake RMC
        • Contact:
          • Marshall Stagg, Site 0191
          • Phone Number: 225-765-3344
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Pontchartrain Cancer Center
        • Contact:
          • David Oubre, Site 0044
          • Phone Number: 985-875-1202
      • New Orleans, Louisiana, United States, 70112
        • Withdrawn
        • Local Institution - 0097
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • American Oncology Partners of Maryland, PA
        • Contact:
          • Ralph Boccia, Site 0007
          • Phone Number: 301-571-2016
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Recruiting
        • Metro-Minnesota Community Clinical Oncology
        • Contact:
          • Yan Ji, Site 0222
          • Phone Number: 952-993-3252
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Hattiesburg Clinic Hematology/Oncology
        • Contact:
          • John Hrom, Site 0128
          • Phone Number: 601-261-1700
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Not yet recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
          • Jamie Koprivnikar, Site 0212
          • Phone Number: 551-996-3925
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
        • Contact:
          • Uma Borate, Site 0206
          • Phone Number: 503-418-2294
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
        • Contact:
          • Wahid Hanna, Site 0174
          • Phone Number: 865-544-9171
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Guillermo Garcia-Manero, Site 0228
          • Phone Number: 713-745-3428
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Not yet recruiting
        • Local Institution - 0236
        • Contact:
          • Site 0236
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Blue Ridge Cancer Care
        • Contact:
          • Amanda Gillespie-Twardy, Site 0229
          • Phone Number: 540-982-0237
    • Washington
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Contact:
          • Rangaswamy Chintapatla, Site 0203
          • Phone Number: 509-783-4637
      • Seattle, Washington, United States, 98133
        • Withdrawn
        • Local Institution - 0213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and:.

    i) < 5% blasts in bone marrow and < 1% blasts in peripheral blood.

  • Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
  • Participant has never received treatment with an erythropoiesis stimulating agent (ESA).
  • 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 mean baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. Mean Hb is defined as the mean of all central/ local/ pretransfusion available Hb measurements during the 16 weeks prior to randomization (with a minimum of 2 measurements at least 1 week apart). Only Hb levels > 21 days following a transfusion are acceptable. The last measurement must be within 35 days of randomization.

Exclusion Criteria

  • Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Luspatercept
Biological: Luspatercept
Specified dose on specified days
Other Names:
  • ACE-536
  • BMS-986346
  • Reblozyl®
Active Comparator: Epoetin Alfa
Biological: Epoetin Alfa
Specified dose on specified days
Other Names:
  • PROCRIT®
  • Epogen®
  • BINOCRIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
Time Frame: Up to Week 96
TD is defined as ≥ 3 red blood cells (RBC) units/16 weeks assessed by International Working Group (IWG) 2018.
Up to Week 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 grams/deciliter (g/dL) in any continuous 16-week interval within the 48 week Treatment Period in the absence of transfusion
Time Frame: Up to Week 48
Up to Week 48
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame: Up to Week 48
Up to Week 48
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame: From Week 49 to Week 96
From Week 49 to Week 96
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame: Up to Week 96
Up to Week 96
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame: Up to Week 48
Up to Week 48
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame: From Week 49 to Week 96
From Week 49 to Week 96
Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
Time Frame: Up to Week 96
Up to Week 96
Mean Hb change over fixed 24-week periods compared to the baseline Hb
Time Frame: Baseline, Week 24, Week 48, Week 72, Week 96
Baseline, Week 24, Week 48, Week 72, Week 96
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week treatment period in the absence of transfusion
Time Frame: Up to Week 96
Up to Week 96
Number of participants with TD by week 48
Time Frame: Up to Week 48
Up to Week 48
Time to TD (IWG 2018 defined as ≥ 3 RBC units/16 weeks) during any continuous 16-week interval until the end of study
Time Frame: Up to 5 years
Up to 5 years
Time from first Luspatercept dose to first RBC transfusion
Time Frame: Up to 5 years
Up to 5 years
Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 48-week treatment period in absence of transfusion
Time Frame: Up to Week 48
Up to Week 48
Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 96-week treatment period in absence of transfusion
Time Frame: Up to Week 96
Up to Week 96
Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 48-week Treatment Period in the absence of transfusion)
Time Frame: Up to Week 48
Up to Week 48
Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week Treatment Period in the absence of transfusion)
Time Frame: Up to Week 96
Up to Week 96
Number of participants with RBC transfusion independence over at least a consecutive 24-week period
Time Frame: Up to 5 years
Up to 5 years
Number of transfusions
Time Frame: Up to 5 years
Up to 5 years
Number of transfusions visits/units
Time Frame: Up to 5 years
Up to 5 years
Change from baseline in subscales of self-reported health-related quality-of-life (HRQoL) assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An)
Time Frame: Baseline, Up to 5 years
Baseline, Up to 5 years
Change from baseline in self-reported HRQoL assessed by the European quality of life questionnaire 5-dimension (EQ-5D-5L)
Time Frame: Baseline, Up to 5 years
Baseline, Up to 5 years
Number of participants with adverse events (AEs)
Time Frame: Up to Week 102
Up to Week 102
Number of participants with antidrug antibody (ADA) (positive or negative)
Time Frame: Up to Week 102
Up to Week 102
Pharmacokinetics (PK): Serum concentration
Time Frame: Up to Week 96
Up to Week 96
PK: Area under the plasma concentration time curve (AUC)
Time Frame: Up to Week 96
Up to Week 96
Number of participants with a platelet response at Week 24, Week 48 and Week 96
Time Frame: Up to Week 96
Platelet response is defined as an increase from baseline in number of platelets to ≥ 30 × 10^9/L at Week 24, Week 48 and Week 96.
Up to Week 96
Number of participants with a neutrophil response at Week 24, Week 48 and Week 96
Time Frame: Up to Week 96
Neutrophil response is defined as an absolute increase from baseline of > 0.5 × 10^9/L neutrophils at Week 24, Week 48 and Week 96.
Up to Week 96
Number of participants with acute myeloid leukemia (AML) progression
Time Frame: Up to 5 years
Up to 5 years
Time to AML progression
Time Frame: Up to 5 years
Up to 5 years
Number of participants with high risk myelodysplastic syndromes (MDS) progression
Time Frame: Up to 5 years
Up to 5 years
Time to high-risk MDS progression
Time Frame: Up to 5 years
Up to 5 years
Time from date of randomization up to death due to any cause
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

June 25, 2027

Study Completion (Estimated)

March 11, 2030

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA056-025
  • 2022-500430-29-00 (Other Identifier: EU CTR Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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