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A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve (COMMANDS)

  • Clinicaltrials.gov identifier

    NCT03682536

  • Recruitment Status

    Recruiting

  • First Posted

    September 24, 2018

  • Last update posted

    July 4, 2022

Study Description

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).

  • Condition or Disease:Myelodysplastic Syndromes
  • Intervention/Treatment: Drug: Luspatercept
    Drug: Epoetin alfa
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 350 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: June 2027

Arms and interventions

Arm Intervention/treatment
Experimental: Luspatercept
Drug: Luspatercept
Specified dose on specified days
Active Comparator: Epoetin alfa
Drug: Epoetin alfa
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Red blood cell transfusion independence (RBC-TI) for 12 weeks (84 days) with a mean hemoglobin increase ≥ 1.5 g/dL [ Time Frame: Week 1 through Week 24 ]
  • Secondary Outcome Measures: 1. RBC-TI for 24 weeks [ Time Frame: Week 1 through Week 24 ]
  • 2. Mean hemoglobin change over 24 weeks [ Time Frame: Week 1 through Week 24 ]
  • 3. Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG) [ Time Frame: Week 1 through Week 24 ]
  • 4. Time to HI-E [ Time Frame: Week 1 through Week 24 ]
  • 5. RBC-TI for ≥ 12 weeks (84 days) [ Time Frame: Week 1 through Week 24 ]
  • 6. Duration of RBC-TI ≥ 12 weeks (84 days) [ Time Frame: Week 1 through End of Treatment (EOT), up to approximately 60 months ]
  • 7. Time to RBC-TI ≥ 12 weeks (84 days) [ Time Frame: Week 1 through Week 24 ]
  • 8. Time to first red blood cell (RBC) transfusion [ Time Frame: Week 1 through EOT, up to approximately 60 months ]
  • 9. RBC transfusion burden on treatment [ Time Frame: Week 1 through Week 24 ]
  • 10. RBC-TI for ≥ 56 days (8 weeks) [ Time Frame: Week 1 through Week 24 ]
  • 11. RBC-TI for a consecutive 24-week period [ Time Frame: Week 1 through Week 48 ]
  • 12. The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) [ Time Frame: Screening through Week 24 ]
  • 13. The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire [ Time Frame: Screening through Week 24 ]
  • 14. Number of participants with Adverse Events (AEs) [ Time Frame: Week 1 through 42 days post last dose ]
  • 15. Pharmacokinetic - area under the concentration-time curve (AUC) [ Time Frame: Randomization through 1-year post first dose ]
  • 16. Pharmacokinetic - maximum plasma concentration of drug (Cmax) [ Time Frame: Randomization through 1-year post first dose ]
  • 17. Frequency of antidrug antibodies (ADA) [ Time Frame: Randomization through 1-year post first dose ]
  • 18. Number of participants progressing to acute myeloid leukemia (AML) [ Time Frame: Randomization through up to 60 months ]
  • 19. Percentage of participants progressing to AML [ Time Frame: Randomization through up to 60 months ]
  • 20. Time to AML progression [ Time Frame: Randomization through up to 60 months ]
  • 21. Overall survival [ Time Frame: Randomization through up to 60 months ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

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 #.

Locations

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

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Center For Cancer and Blood Disorders
Bethesda

United States, Maryland
Center For Cancer And Blood Disorders
Bethesda

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HCA Midwest Health
Kansas City

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Astera Cancer Care East Brunswick
East Brunswick

United States, New Jersey
Hackensack University Medical Center
Hackensack

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Greenville

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Providence Portland Medical Center
Portland

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Oregon Health & Science University
Portland

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Univ of Pittsburgh Medical Center
Pittsburgh

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Carolina Blood and Cancer Care
Rock Hill

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Tennessee Oncology
Nashville

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Baylor University Medical Center
Dallas

United States, Texas
UT Southwestern Simmons Cancer Center
Dallas

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University of Texas- MD Anderson
Houston

United States, Utah
Utah Cancer Specialists - South Salt Lake
Salt Lake City

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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
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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

Sponsors and Collaborators

Celgene

Acceleron Pharma Inc.

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03682536 History of Changes
  • Other Study ID Numbers: ACE-536-MDS-002, U1111-1218-1810, 2017-003190-34
  • First Posted: September 24, 2018 Key Record Dates
  • Last Update Posted: July 4, 2022
  • Last Verified: July 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Luspatercept
    ACE-536
    Anemia
    Myelodysplastic Syndromes
    Blood Transfusion
    RBC Transfusion
    Erythropoiesis-stimulating agents
    Erythropoietin
    Myelodysplasia
  • Additional relevant MeSH terms: Preleukemia
    Anemia
    Myelodysplastic Syndromes
    Syndrome
    Disease
    Pathologic Processes
    Hematologic Diseases
    Bone Marrow Diseases
    Precancerous Conditions
    Neoplasms