Myelodysplastic Syndrome Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

360

Study ID:

NCT05949684

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 130 Locations for this study

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Community Cancer Institute
Clovis California, 93611, United States More Info
Haifaa Abdulhaq, Site 0070
Contact
559-618-6208
John Muir Medical Center - Concord Campus
Concord California, 94520, United States More Info
Gigi Chen, Site 0183
Contact
925-674-2580
Compassionate Cancer Care Medical Group
Fountain Valley California, 92708, United States More Info
Haresh Jhangiani, Site 0179
Contact
951-371-2411
Local Institution - 0095
Fresno California, 93703, United States
Local Institution - 0247
Orange California, 92868, United States More Info
Site 0247
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Ventura County Hematology Oncology Specialists
Oxnard California, 93030, United States More Info
Lynn Kong, Site 0209
Contact
000-000-0000
Local Institution - 0098
Fort Collins Colorado, 80528, United States
Hartford Hospital (HH)
Hartford Connecticut, 06102, United States More Info
Devendra KC, Site 0227
Contact
860-972-5361
Yale-New Haven Hospital
New Haven Connecticut, 06510, United States More Info
Amer Zeidan, Site 0173
Contact
203-737-7078
Halifax Health Medical Center
Daytona Beach Florida, 32114, United States More Info
Ruby Anne Deveras, Site 0231
Contact
386-254-4212
Florida Cancer Specialists - South
Fort Myers Florida, 33901, United States More Info
Syed Zafar, Site 0202
Contact
239-274-9930
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Maxim Norkin, Site 0180
Contact
248-756-4524
D&H Cancer Research Center LLC
Margate Florida, 33063, United States More Info
David Kahn, Site 0224
Contact
954-773-9890
BRCR Global
Plantation Florida, 33322, United States More Info
Jason Tache, Site 0163
Contact
516-447-0614
Florida Cancer Specialists - North
Saint Petersburg Florida, 33705, United States More Info
Gustavo Fonseca, Site 0201
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000-000-0000
Local Institution - 0238
Tamarac Florida, 33321, United States More Info
Site 0238
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Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
rami komrokji, Site 0106
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513-504-9712
Local Institution - 0240
Honolulu Hawaii, 96813, United States More Info
Site 0240
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Orchard Healthcare Research Inc.
Skokie Illinois, 60077, United States More Info
Ira Oliff, Site 0184
Contact
224-534-7580
Our Lady of the Lake RMC
Baton Rouge Louisiana, 70808, United States More Info
Marshall Stagg, Site 0191
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225-765-3344
Pontchartrain Cancer Center
Covington Louisiana, 70433, United States More Info
David Oubre, Site 0044
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985-875-1202
Local Institution - 0097
New Orleans Louisiana, 70112, United States
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States More Info
Ralph Boccia, Site 0007
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301-571-2016
Metro-Minnesota Community Clinical Oncology
Saint Louis Park Minnesota, 55426, United States More Info
Yan Ji, Site 0222
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952-993-3252
Hattiesburg Clinic Hematology/Oncology
Hattiesburg Mississippi, 39401, United States More Info
John Hrom, Site 0128
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601-261-1700
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Jamie Koprivnikar, Site 0212
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551-996-3925
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Uma Borate, Site 0206
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503-418-2294
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States More Info
Wahid Hanna, Site 0174
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865-544-9171
Local Institution - 0236
Richmond Virginia, 23219, United States More Info
Site 0236
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Blue Ridge Cancer Care
Roanoke Virginia, 24014, United States More Info
Amanda Gillespie-Twardy, Site 0229
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540-982-0237
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States More Info
Rangaswamy Chintapatla, Site 0203
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509-783-4637
Fred Hutchinson Cancer Center at University of Washington Medical Center - Northwest
Seattle Washington, 98133, United States More Info
Paul Martin, Site 0213
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206-606-5800
Centro Mdico "Barrio Parque"
Buenos Aires , 1425, Argentina More Info
Claudio Iastrebner, Site 0010
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+54-911-69816300
Local Institution - 0012
Buenos Aires , CP128, Argentina More Info
Site 0012
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Local Institution - 0009
Ciudad Autónoma de Buenos Aires , C1426, Argentina More Info
Site 0009
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Blacktown Hospital
Blacktown New South Wales, 2148, Australia More Info
Kenny Tang, Site 0071
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0286708421
Royal Prince Alfred Hospital
Camperdown New South Wales, 2050, Australia More Info
Stephen Larsen, Site 0113
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+61 2 9515 8031
Local Institution - 0254
Coffs Harbour New South Wales, 2450, Australia More Info
Site 0254
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Local Institution - 0246
Gold Coast Queensland, 4217, Australia More Info
Site 0246
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Monash Health
Clayton Victoria, 3168, Australia More Info
Jake Shortt, Site 0054
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+61412633726
Austin Health
Heidelberg Victoria, 3084, Australia More Info
Chun Fong, Site 0052
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61394966731
Hospital Universitario Walter Cantidio
Fortaleza Ceará, 60430, Brazil More Info
Silvia Maria Magalhaes, Site 0059
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85999818108
Hospital São Lucas da PUCRS
Porto Alegre Rio Grande Do Sul, 90610, Brazil More Info
Mariza Schaan, Site 0101
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55 5133203319
HEMORIO
Rio de Janeiro , 20211, Brazil More Info
Viviani Pessoa, Site 0056
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21-981698808
Hospital das Clinicas FMUSP
São Paulo , 05403, Brazil More Info
Elvira Velloso, Site 0003
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+551145737631
Local Institution - 0049
Calgary Alberta, T2N 4, Canada More Info
Site 0049
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Local Institution - 0112
Vancouver British Columbia, V6Z 1, Canada More Info
Site 0112
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Victoria Hospital & Children's Hospital - London Health Sciences Centre
London Ontario, N6A 5, Canada More Info
lalit Saini, Site 0050
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519-685-8500x56072
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada More Info
Rena Buckstein, Site 0017
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4163992979
Local Institution - 0109
Hefei Anhui, 23007, China More Info
Site 0109
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Local Institution - 0217
Beijing Beijing, 10004, China More Info
Site 0217
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Beijing Peking Union Medical College Hospital
Beijing Beijing, 10073, China More Info
Bing Han, Site 0030
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8613601059938
The First Affiliated Hospital of Chongqing Medical University
Chongqing Chongqing, 40001, China More Info
li wang, Site 0223
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18623015252
Local Institution - 0096
Fuzhou Fujian Fujian, 35000, China
Local Institution - 0220
Xiamen Fujian, 36100, China More Info
Site 0220
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Local Institution - 0031
Guangzhou Guangdong, 45000, China
The First Hospital of Harbin
Harbin Heilongjiang, 15001, China More Info
Tiejun Gong, Site 0038
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13836027737
Local Institution - 0194
Zhengzhou Henan, 45000, China More Info
Site 0194
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43005, China More Info
Min Zhang, Site 0108
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15871818568
Local Institution - 0089
Changsha Hunan, 41000, China More Info
Site 0089
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Local Institution - 0032
Nanjing Jiangsu, 21002, China More Info
Site 0032
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The First Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China More Info
Fei Li, Site 0079
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13970038386
The First Hospital of Jilin University
Changchun Jilin, 13002, China More Info
sujun gao, Site 0043
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+86 15843073208
The First Hospital of China Medical University
Shenyang Liaoning, 11000, China More Info
Xiaojing Yan, Site 0048
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13889128302
Local Institution - 0216
Xian Shaanxi, 71006, China More Info
Site 0216
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Local Institution - 0111
Qingdao Shandong, 26600, China More Info
Site 0111
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Local Institution - 0218
Shanghai Shanghai, 20003, China More Info
Site 0218
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Local Institution - 0075
Cheng Du Sichuan, 61004, China More Info
Site 0075
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Institute of hematology&blood disease hospital
Tianjin Tianjin, 30002, China More Info
zhijian xiao, Site 0103
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+86 13821085716
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China More Info
Hongyan Tong, Site 0029
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13958122357
Local Institution - 0033
Wenzhou Zhejiang, 32500, China More Info
Site 0033
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Local Institution - 0147
Medellin Antioquia, 05034, Colombia More Info
Site 0147
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Local Institution - 0152
Valledupar Cesar, 20000, Colombia More Info
Site 0152
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Local Institution - 0149
Montería Córdoba, 23000, Colombia More Info
Site 0149
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Local Institution - 0080
Brno Brno-město, 625 0, Czechia More Info
Site 0080
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Fakultni nemocnice Ostrava
Ostrava Moravskoslezský Kraj, 708 5, Czechia More Info
Zdenek Koristek, Site 0092
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+420597374566
Vseobecna fakultni nemocnice v Praze
Praha 2 , 12808, Czechia More Info
Anna JONASOVA, Site 0090
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+420224966209
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice Alpes-Maritimes, 06202, France More Info
Thomas Cluzeau, Site 0011
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33492039268
CHU Bordeaux Haut-Leveque
Pessac Aquitaine, 33600, France More Info
Sophie Dimicoli-Salazar, Site 0016
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33557656511
Local Institution - 0019
Tours Indre-et-Loire, 37032, France More Info
Site 0019
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Chu Grenoble Alpes
La Tronche Isère, 38700, France More Info
Mathieu Meunier, Site 0116
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33476765755
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandoeuvre lès Nancy Lorraine, 54511, France More Info
Maud D'Aveni, Site 0165
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0609481716
Local Institution - 0248
Villejuif Val-de-Marne, 94805, France More Info
Site 0248
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Hôpital Saint-Louis
Paris , 75010, France More Info
Pierre FENAUX, Site 0015
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+33171207022
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse , 31100, France More Info
Thibault Comont, Site 0140
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0033531156266
Local Institution - 0250
Kempten Bayern, 87439, Germany More Info
Site 0250
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Local Institution - 0168
Koblenz Rheinland-Pfalz, 56068, Germany More Info
Site 0168
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Universitätsklinikum Leipzig
Leipzig Sachsen, 04103, Germany More Info
Dominic Brauer, Site 0171
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493419713859
Local Institution - 0251
Jena Thüringen, 07747, Germany More Info
Site 0251
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Praxis fur Hamatologie und Onkologie
Berlin , 10117, Germany More Info
Stephan Fuhrmann, Site 0169
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+49(0)152 54777515
Local Institution - 0028
Berlin , 14195, Germany More Info
Site 0028
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Universitaetsklinikum Duesseldorf
Düsseldorf , 40225, Germany More Info
Norbert Gattermann, Site 0207
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0211-81 16500
Local Institution - 0255
Lübeck , 23562, Germany More Info
Site 0255
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Kliniken Ostalb, Stauferklinikum
Mutlangen , 73557, Germany More Info
Holger Hebart, Site 0167
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4971717011302
Local Institution - 0166
Würzburg , 97080, Germany More Info
Site 0166
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Local Institution - 0132
Patras Achaḯa, 26504, Greece More Info
Site 0132
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Local Institution - 0242
Patras Achaḯa, 26504, Greece
General Hospital of Athens "G. Gennimatas"
Athens Attikí, 115 2, Greece More Info
Eurydiki Michalis, Site 0084
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+306944452898
Attikon General University Hospital
Chaidari Attikí, 12462, Greece More Info
Vasiliki Pappa, Site 0131
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00306937255084
University Hospital of Alexandroupolis
Alexandroupolis , 08100, Greece More Info
IOANNIS KOTSIANIDIS, Site 0082
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+302551353739
Local Institution - 0024
Eger Heves, 0, Hungary More Info
Site 0024
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Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyiregyhaza Szabolcs-Szatmár-Bereg, 4400, Hungary More Info
Laszlo Rejto, Site 0021
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42599700
Semmelweis Egyetem
Budapest , 1088, Hungary More Info
ZSOLT GYORGY Nagy, Site 0026
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36208258660
Local Institution - 0193
New Delhi Delhi, 11002, India More Info
Site 0193
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Local Institution - 0235
New Delhi Delhi, 11008, India More Info
Site 0235
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Local Institution - 0243
Ahmedabad Gujarat, 38000, India More Info
Site 0243
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Local Institution - 0177
Bengaluru Karnataka, 56002, India More Info
Site 0177
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Local Institution - 0178
Bhubaneswar Odisha, 75100, India More Info
Site 0178
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Local Institution - 0185
Hyderabad , 50003, India
Local Institution - 0186
New Delhi , 11002, India
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano Lombardia, 20122, Italy More Info
Bruno Fattizzo, Site 0137
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02 55033477
ASST Grande Ospedale Metropolitano Niguarda
Milan Milano, 20162, Italy More Info
Marta Riva, Site 0134
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0264442668
Humanitas
Rozzano Milano, 20089, Italy More Info
Matteo Giovanni Della Porta, Site 0136
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0282247668
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino Piemonte, 10128, Italy More Info
Daniela Cilloni, Site 0085
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+390115082224
Azienda Ospedaliera Universitaria Careggi
Firenze Toscana, 50134, Italy More Info
VALERIA SANTINI, Site 0138
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0557947296
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna , 40138, Italy More Info
Stefania Paolini, Site 0135
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+393392231941
Local Institution - 0076
Reggio Calabria , 89133, Italy More Info
Site 0076
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Local Institution - 0244
Roma , 00168, Italy More Info
Site 0244
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Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona , 37134, Italy More Info
Andrea Bernardelli, Site 0133
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3272052368
Local Institution - 0142
Mexico City Distrito Federal, 14080, Mexico More Info
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Local Institution - 0069
Huixquilucan , 52787, Mexico More Info
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Local Institution - 0150
Puebla , 72424, Mexico More Info
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Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych Dolnośląskie, 58-30, Poland More Info
Aleksandra Butrym, Site 0130
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+48502657840
Local Institution - 0060
Gdańsk , 80-95, Poland More Info
Site 0060
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Pratia Onkologia Katowice
Katowice , 40-51, Poland More Info
Sebastian Grosicki, Site 0061
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+48600388282
MTZ Clinical Research powered by Pratia
Warsaw , 02-17, Poland More Info
Krzysztof Madry, Site 0062
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485725959
Auxilio Mutuo Cancer Center
San Juan , 00917, Puerto Rico More Info
Adelba Torres Lopez, Site 0219
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7877582000
Local Institution - 0237
San Juan , 00917, Puerto Rico
Hospital Universitari Vall d'Hebron
Barcelona Barcelona [Barcelona], 08035, Spain More Info
David Ferreiras, Site 0198
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34934893000Ext6417
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat Catalunya [Cataluña], 08908, Spain More Info
Montserrat Arnan Sangerman, Site 0197
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34932607750
Hospital Clinico de Valencia
Valencia Valenciana, Comunitat, 46010, Spain More Info
Maria del Tormo Diaz, Site 0196
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+34961973838
Local Institution - 0199
Granada , 18012, Spain More Info
Site 0199
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Local Institution - 0252
Madrid , 28006, Spain More Info
Site 0252
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Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca , 37007, Spain More Info
Maria Diez, Site 0200
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34699508223

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

360

Study ID:

NCT05949684

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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