NCT03682536
Recruiting
September 24, 2018
July 4, 2022
Brief summary:
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Luspatercept |
Drug: Luspatercept Specified dose on specified days |
Active Comparator: Epoetin alfa |
Drug: Epoetin alfa Specified dose on specified days |
Inclusion Criteria: Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow Endogenous serum erythropoietin (sEPO) level of < 500 U/L Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 Exclusion Criteria: Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia Known history of diagnosis of Acute myeloid leukemia (AML) Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment Other protocol-defined inclusion/exclusion criteria apply
Contact: BMS Study Connect Contact www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
United States, Alabama
Alabama Oncology - Grandview Cancer Center
Birmingham
United States, California
Alta Bates Summit Medical Center
Berkeley
United States, California
Sharp Memorial Hospital
San Diego
United States, California
Innovative Clinical Research Institute
Whittier
United States, California
Innovative Clinical Research Institute
Whittier
United States, Connecticut
Yale Cancer Center
New Haven
United States, District of Columbia
National Association of Veterans Research and Education Foundations NAVREF
Washington
United States, Florida
Florida Cancer Institute
Hudson
United States, Florida
Florida Cancer Specialists North Region Sarah Cannon Research
Saint Petersburg
United States, Florida
SCRI Florida Cancer Specialists PAN
Tallahassee
United States, Florida
Moffitt Cancer Center
Tampa
United States, Florida
Moffitt Cancer Center
Tampa
United States, Florida
Florida Cancer Specialists
West Palm Beach
United States, Georgia
Northwest Georgia Oncology Centers, PC
Austell
United States, Kentucky
Norton Healthcare
Louisville
United States, Kentucky
Western Kentucky Hematology and Oncology Group
Paducah
United States, Maryland
Center For Cancer and Blood Disorders
Bethesda
United States, Maryland
Center For Cancer And Blood Disorders
Bethesda
United States, Missouri
HCA Midwest Health
Kansas City
United States, New Jersey
Astera Cancer Care East Brunswick
East Brunswick
United States, New Jersey
Hackensack University Medical Center
Hackensack
United States, North Carolina
East Carolina University
Greenville
United States, Oregon
Providence Portland Medical Center
Portland
United States, Oregon
Oregon Health & Science University
Portland
United States, Pennsylvania
Univ of Pittsburgh Medical Center
Pittsburgh
United States, South Carolina
Carolina Blood and Cancer Care
Rock Hill
United States, Tennessee
Tennessee Oncology
Nashville
United States, Texas
Baylor University Medical Center
Dallas
United States, Texas
UT Southwestern Simmons Cancer Center
Dallas
United States, Texas
University of Texas- MD Anderson
Houston
United States, Utah
Utah Cancer Specialists - South Salt Lake
Salt Lake City
United States, Virginia
University of Virginia Health System
Charlottesville
United States, Virginia
Peninsula Cancer Institute
Chesapeake
United States, Washington
Providence Regional Cancer Partnership
Everett
Australia, New South Wales
Border Medical Oncology - Albury Wodonga Regional Cancer Centre
Albury
Australia, New South Wales
Blacktown Hospital
Blacktown
Australia, New South Wales
Local Institution - 213
Blacktown
Australia, New South Wales
Concord Repatriation General Hospital
Concord
Australia, New South Wales
St George Hospital
Kogarah
Australia, New South Wales
Shoalhaven Cancer Care Centre
Nowra
Australia, New South Wales
Newcastle Calvary Mater Hospital
Waratah
Australia, New South Wales
Wollongong Hospital
Wollongong
Australia, Queensland
Icon Cancer Foundation
Auchenflower
Australia, South Australia
Royal Adelaide Hospital
Adelaide
Australia, Victoria
Monash Medical Centre
Clayton
Australia, Victoria
Cabrini Hospital
Malvern
Australia, Victoria
Local Institution - 203
Malvern
Australia, Victoria
The Alfred Hospital
Melbourne
Australia, Western Australia
Perth Blood Institute
West Perth
Australia
Local Institution - 212
Randwick
Australia
The Prince of Wales Hospital
Randwick
Austria
Elisabethinen Hospital Linz
Linz
Austria
Medizinische Universitat Wien
Vienna
Belgium
ZNA Middelheim
Antwerpen
Belgium
Algemeen Ziekenhuis Klina
Brasschaat
Belgium
Cliniques Universitaires St-Luc
Brussels
Belgium
Grand Hopital de Charleroi
Charleroi
Belgium
AZ Groeninge
Kortrijk
Belgium
UZ Gasthuisberg
Leuven
Belgium
H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat
Roeselare
Canada, Alberta
Tom Baker Cancer Centre
Calgary
Canada, Alberta
University of Alberta
Edmonton
Canada, Ontario
Juravinski Cancer Centre
Hamilton
Canada, Ontario
Local Institution - 142
Hamilton
Canada, Ontario
Ottawa General Hospital
Ottawa
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto
Canada, Quebec
Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal
Montreal
Canada, Quebec
Sir Mortimer B. Davis - Jewish Genl
Montreal
Canada, Saskatchewan
Saskatoon Cancer Center
Saskatoon
Canada
Centre Hospitalier Universitaire de Sherbrooke CHUS
Sherbrooke
Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove
Czechia
Local Institution - 560
Hradec Kralove
Czechia
Fakultni Nemocnice Ostrava
Ostrava-Poruba
Czechia
Local Institution - 564
Ostrava-Poruba
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague 10
Czechia
Local Institution - 562
Praha 2
Czechia
Vseobecna Fakultni Nemocnice v Praze
Praha 2
Czechia
Ustav hematologie a krevni transfuze
Praha
France
CHU Angers
Angers
France
Local Institution - 317
Angers
France
Centre Hospitalier de la cote basque
Bayonne
France
CHU de Caen
Caen Cedex 9
France
Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon
La Tronche
France
Centre Hospitalier Le Mans
Le Mans
France
CHRU de Lille France
Lille
France
Local Institution - 309
Lille
France
CHU Limoges
Limoges Cedex
France
Hotel Dieu CHU Nantes
Nantes Cedex 01
France
CHU Nice Hopital de L'Archet 2
Nice Cedex 3
France
Assistance Publique - Hopitaux de Paris - Hopitaux Saint-Louis
Paris
France
Local Institution - 302
Paris
France
Cochin, Hôpital
Paris
France
CHU Bordeaux
Pessac
France
Local Institution - 308
Pessac
France
Centre Hospitalier Lyon Sud
Pierre Bénite
France
CHU de Poitiers
Poitiers
France
Institut de Cancérologie Strasbourg Europe
Strasbourg
France
CHU Purpan
Toulouse
France
CHRU Hopital BretonneauOnco-hematologie
Tours cedex
France
CHU de Nancy-Hopital Brabois Adulte
Vandoeuvre les Nancy
Germany
Stauferklinikum Schwab. Gmund
Baden-Warttemberg
Germany
Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin
Germany
Local Institution - 426
Dresden
Germany
Universitaetsklinikum Carl Gustav Carus
Dresden
Germany
St. Johannes Krankenhaus Duisburg
Duisburg
Germany
Marien Hospital
Dusseldorf
Germany
OncoResearch Lerchenfeld GmbH
Hamburg
Germany
Universitatsklinikum Schleswig-Holstein
Keil
Germany
Praxis fuer Haematologie und Onkologie Koblenz
Koblenz
Germany
Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hamatologie u. Onkologie
Köln
Germany
Local Institution - 430
Leipzig
Germany
Universitatsklinikum Leipzig
Leipzig
Germany
Universitaetsklinikum Mannheim
Mannheim
Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munchen
Germany
University Hospital of Ulm
Ulm
Germany
Klinkum der Stadt Villingen-Schwenningen GmbH
Villingen-Schwenningen
Germany
Rems-Murr-Kliniken
Winnenden
Germany
Hamatologisch-onkologische Praxis
Würzburg
Greece
University Hospital of Alexandroupolis
Alexandroupolis
Greece
Evangelismos General Hospital of Athens
Athens
Greece
Laiko General Hospital of Athens
Athens
Greece
Laiko General Hospital of Athens
Athens
Greece
Attikon university General Hospital
Athens
Greece
General Hospital of Athens - George Gennimatas
Athina
Greece
Local Institution - 395
Athina
Greece
University General Hospital of Heraklion
Heraklion
Greece
University of Patras
Patras
Greece
University General Hospital of Patras
Rio Patras
Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki
Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki
Hungary
Semmelweis Egyetem
Budapest
Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
Budapest
Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen
Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvar
Hungary
Local Institution - 536
Nyiregyhaza
Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház
Nyiregyhaza
Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged
Israel
Carmel Medical Center
Haifa
Israel
Shaare Zedek Medical Center
Jerusalem
Israel
Hadassah Medical Center
Jerusalem
Israel
Meir Medical Center
Kfar-Saba
Israel
Galilee Medical Center
Nahariya
Israel
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv
Israel
Shamir Medical Center - Assaf Harofeh
Zerifin
Italy
Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M
Bologna
Italy
Azienda Ospedaliera Universitaria Careggi
Firenze
Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola
Italy
A.O. Ospedale Ca Granda - Niguarda
Milano
Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano
Italy
Hospital of Di Padova
Padova
Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Di Calabria
Italy
Local Institution - 326
Reggio Di Calabria
Italy
Fondazione PTV Policlinico Tor Vergata
Roma
Italy
Local Institution - 328
Roma
Italy
Azienda Ospedaliera Sant Andrea
Roma
Italy
La Sapienza, University of Rome
Rome
Italy
Istituto Clinico Humanitas
Rozzano
Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
Udine
Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki-Shi
Japan
Fujisawa City Hospital
Fujisawa-Shi
Japan
National Hospital Organization Kyushu Medical Center
Fukuoka
Japan
Hitachi General Hospital
Hitachi, Ibaraki
Japan
Kameda General Hospital
Kamogawa
Japan
JCHO Kyushu Hospital
Kitakyushu-Shi
Japan
Matsuyama Red Cross Hospital
Matsuyama
Japan
Nagaoka Red Cross Hospital
Nagaoka-Shi
Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki
Japan
National Hospital Organization - Nagoya Medical Center
Nagoya-shi
Japan
Ogaki Municipal Hospital
Ogaki
Japan
Okayama City General Medical Center
Okayama
Japan
Kindai University Hospital
Osaka-Sayama
Japan
Osaka City University Hospital
Osaka
Japan
Kitasato University Hospital
Sagamihara
Japan
Aiiku Hospital
Sapporo-shi
Japan
Tohoku University Hospital
Sendai
Japan
Japan Red Cross Medical Center
Shibuya-ku
Japan
Dokkyo Medical University Hospital
Shimotsuga-gun
Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo
Korea, Republic of
Pusan National University Hospital
Busan
Korea, Republic of
Kyungpook National University Hospital
Daegu
Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-Gun
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si
Korea, Republic of
Local Institution - 256
Seoul
Korea, Republic of
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul
Korea, Republic of
Samsung Medical Center
Seoul
Korea, Republic of
Seoul National University Hospital
Seoul
Korea, Republic of
Asan Medical Center
Seoul
Korea, Republic of
Local Institution - 254
Seoul
Lithuania
Hospital of Lithuanian University Health and Sciences
Kaunas
Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius
Netherlands
VU University Medical Center
Amsterdam
Netherlands
HagaZiekenhuis
Den Haag
Netherlands
Radboudumc
Nijmegen
Netherlands
Erasmus Universitair Medisch Centrum
Rotterdam
Netherlands
Zuyderland Medisch Centrum
Sittard-Geleen
Poland, Lódzkie
Local Institution - 570
Lodz
Poland
Local Institution - 575
Gdansk
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz
Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku
Lubin
Poland
Local Institution - 576
Poznan
Poland
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan
Poland
Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie
Rzwszow
Poland
Wojewodzki Szpital Specjalistyczny im Korczaka w Supsku
Slupsk
Poland
Specjalistyczny Szpital im. dra Alfreda Sokolowskiego
Walbrzych
Poland
Wojskowy Instytut Medyczny
Warsaw
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw
Poland
Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych
Wroclaw
Portugal
Hospital José Joaquim Fernandes
Beja
Portugal
Hospital de Braga
Braga
Portugal
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
Lisboa
Portugal
Ipo Instituto Portugues De Oncologia Porto
Porto
Portugal
Centro Hospitalar de Setubal EPE
Setubal
Russian Federation
Kaluga Regional Hospital
Kaluga
Russian Federation
Kaluga Regional Hospital
Kaluga
Russian Federation
Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec
Kirov
Russian Federation
Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec
Kirov
Russian Federation
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk
Russian Federation
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk
Russian Federation
Moscow Clinical Scientific Center
Moscow
Russian Federation
Moscow Clinical Scientific Center
Moscow
Russian Federation
City Clinical Hospital 52
Moscow
Russian Federation
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
Moscow
Russian Federation
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
Moscow
Russian Federation
City Clinical Hospital 40
Moscow
Russian Federation
Saratov State Medical University
Saratov
Russian Federation
Saratov State Medical University
Saratov
Russian Federation
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg
Russian Federation
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg
Russian Federation
First Pavlov State Medical University of St. Petersburg
St. Petersburg
Russian Federation
First Pavlov State Medical University of St. Petersburg
St. Petersburg
Russian Federation
Tula Regional Oncology Center
Tula
Russian Federation
Tula Regional Oncology Center
Tula
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Spain
Instituto Catalan de Oncologia-Hospital Duran i Reynals
Barcelona
Spain
Hospital Virgenes de las Nieves
Granada
Spain
Hospital General Universitario Gregorio Maranon
Madrid
Spain
Hospital Universitario 12 de Octubre
Madrid
Spain
Hospital Universitario Virgen De La Victoria
Malaga
Spain
Hospital General Universitario Morales Meseguer
Murcia
Spain
C. H. de Orense
Ourense
Spain
Hospital Universitario Central de Asturias
Oviedo
Spain
Hospital Son Espases
Palma de Mallorca
Spain
Hospital Universitario de Salamanca
Salamanca
Spain
Hospital Universitario Virgen del Rocio
Seville
Spain
Hospital Clinico Universitario de Valencia
Valencia
Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Sweden
Sahlgrenska Universitetssjukhuset
Goteborg
Sweden
Skanes Universitetssjukhus Lund
Lund
Sweden
Karolinska Universitetssjukhuset - Huddinge
Stockholm
Switzerland
Inselspital Bern
Bern
Switzerland
Local Institution - 450
Bern
Switzerland
Luzerner Kantonsspital
Luzern 16
Switzerland
Kantonsspital Winterthur
Winterthur
Taiwan
Changhua Christian Hospital
Changhua City, Changhua
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Niaosong District Kaohsiung City
Taiwan
China Medical University Hospital
Taichung City
Taiwan
Taichung Veterans General Hospital
Taichung
Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist.
Turkey
Ankara University Medical Faculty
Ankara
Turkey
Celal Bayar University Medical Faculty
Manisa
Turkey
Karadeniz Technical University Medical Faculty
Trabzon
Ukraine
Cherkassy Regional Oncology Center
Cherkassy
Ukraine
Cherkassy Regional Oncology Center
Cherkassy
Ukraine
Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center
Dnipro
Ukraine
Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center
Dnipro
Ukraine
State Institution National Research Centre for Radiation Medicine of NAMS of Ukraine
Kyiv
Ukraine
Institute of Blood Pathology and Transfusion Medicine of the UAMS
Lvov
Ukraine
Institute of Blood Pathology and Transfusion Medicine of the UAMS
Lvov
Ukraine
Mykolaiv Regional Clinical Hospital
Mykolaiv
Ukraine
Mykolaiv Regional Clinical Hospital
Mykolaiv
Ukraine
CI of TRC Ternopil University Hospital
Ternopil
Ukraine
CI of TRC Ternopil University Hospital
Ternopil
United Kingdom
Aberdeen Royal Infirmary
Aberdeen
United Kingdom
Royal Bournemouth Hospital
Bournemouth
United Kingdom
University of Oxford
Headington, Oxford
United Kingdom
Lincoln County Hospital
Lincoln
United Kingdom
Kings College Hospital
London
United Kingdom
Hammersmith Hospital
London
United Kingdom
Christie Hospital NHS Trust
Manchester
Celgene
Acceleron Pharma Inc.
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb