A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

Last updated: March 28, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

3

Condition

Myelodysplastic Syndromes (Mds)

White Cell Disorders

Treatment

Luspatercept

Clinical Study ID

NCT06045689
CA056-1060
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease.

  • Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.

  • Participant must have red blood cell transfusions according to study criteria.

Exclusion

Exclusion Criteria:

  • Participant has known clinically significant anemia due to iron, vitamin B12, orfolate deficiencies, or autoimmune or hereditary hemolytic anemia, orgastrointestinal bleeding.

  • Participant has had a prior allogeneic or autologous stem cell transplant.

  • Participant has known history or diagnosis of AML.

  • Participant has uncontrolled hypertension.

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Luspatercept
Phase: 3
Study Start date:
October 05, 2023
Estimated Completion Date:
December 30, 2027

Connect with a study center

  • Local Institution - 0016

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • UZ Leuven- Gasthuisberg Campus

    Leuven, Vlaams Brabant 3000
    Belgium

    Active - Recruiting

  • AZ Delta- Campus Rumbeke

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

  • AZ Delta-Brugsesteenweg 90

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

  • Local Institution - 0008

    Roeselare, West-Vlaanderen 8800
    Belgium

    Site Not Available

  • Local Institution - 0064

    Brno, Jihomoravský Kraj 625 00
    Czechia

    Site Not Available

  • Local Institution - 0004

    Prague, Praha, Hlavní Mesto 128 00
    Czechia

    Site Not Available

  • Local Institution - 0023

    Praha, Praha, Hlavní Mesto 128 20
    Czechia

    Site Not Available

  • Ustav hematologie a krevni transfuze

    Praha, Praha, Hlavní Mesto 128 20
    Czechia

    Active - Recruiting

  • Local Institution - 0004

    Praha 2, Praha, Hlavní Mesto 128 21
    Czechia

    Site Not Available

  • Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2

    Praha 2, Praha, Hlavní Mesto 128 21
    Czechia

    Active - Recruiting

  • CHU de Nice Archet I

    Nice, Alpes-Maritimes 06202
    France

    Active - Recruiting

  • Local Institution - 0041

    Nice, Alpes-Maritimes 06202
    France

    Site Not Available

  • Local Institution - 0044

    Tours, Indre-et-Loire 37044
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • Local Institution - 0001

    Poitiers, Vienne 86021
    France

    Site Not Available

  • CHU d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • Local Institution - 0026

    Angers, 49933
    France

    Site Not Available

  • CHU de Grenoble Alpes - Hôpital Michallon

    Grenoble cedex 09, 38 38043
    France

    Active - Recruiting

  • Local Institution - 0007

    Grenoble cedex 09, 38 38043
    France

    Site Not Available

  • AP-HP - Hôpital Saint-Louis

    Paris, 75475
    France

    Active - Recruiting

  • Local Institution - 0046

    Paris, 75475
    France

    Site Not Available

  • Local Institution - 0053

    Pierre Benite, 69495
    France

    Site Not Available

  • Hospices Civils de Lyon - Hôpital Lyon Sud

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • Hôpital Bretonneau

    Tour Cedex01, 37044
    France

    Active - Recruiting

  • Klinikum rechts der Isar der Technischen Universitaet Muenchen

    München, Bayern 81675
    Germany

    Active - Recruiting

  • Local Institution - 0013

    München, Bayern 81675
    Germany

    Site Not Available

  • Local Institution - 0040

    Hannover, Niedersachsen 30161
    Germany

    Site Not Available

  • Studienzentrum am Raschplatz GbR

    Hannover, Niedersachsen 30161
    Germany

    Active - Recruiting

  • Local Institution - 0037

    Gütersloh, Nordrhein-Westfalen 33332
    Germany

    Site Not Available

  • Local Institution - 0009

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    Reggio Calabria, Calabria 89133
    Italy

    Active - Recruiting

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli - PO Riuniti

    Reggio Calabria, Calabria 89124
    Italy

    Active - Recruiting

  • Local Institution - 0021

    Reggio Calabria, Calabria 89133
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • Local Institution - 0062

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Fondazione PTV Policlinico Tor Vergata

    Roma, Lazio 00133
    Italy

    Active - Recruiting

  • Local Institution - 0050

    Roma, Lazio 00133
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano (MI), Milano 20089
    Italy

    Active - Recruiting

  • Local Institution - 0029

    Rozzano (MI), Milano 20089
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, Piemonte 28100
    Italy

    Active - Recruiting

  • Local Institution - 0014

    Novara, Piemonte 28100
    Italy

    Site Not Available

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, Piemonte 10128
    Italy

    Active - Recruiting

  • Local Institution - 0045

    Torino, Piemonte 10128
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana 50139
    Italy

    Active - Recruiting

  • Local Institution - 0024

    Firenze, Toscana 50139
    Italy

    Site Not Available

  • Local Institution - 0015

    Pavia, 27100
    Italy

    Site Not Available

  • Local Institution - 0002

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Site Not Available

  • Local Institution - 0030

    Lublin, Lubelskie 20-081
    Poland

    Site Not Available

  • Local Institution - 0010

    Warszawa, Mazowieckie 02-172
    Poland

    Site Not Available

  • MTZ Clinical Research Powered by PRATIA - PPDS

    Warszawa, Mazowieckie 02-172
    Poland

    Active - Recruiting

  • Local Institution - 0034

    Katowice, Slaskie 40-519
    Poland

    Site Not Available

  • Pratia Onkologia Katowice - PRATIA - PPDS

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Local Institution - 0049

    Lodz, 93-513
    Poland

    Site Not Available

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, 93-513
    Poland

    Active - Recruiting

  • Local Institution - 0035

    Wałbrzych, 58-309
    Poland

    Site Not Available

  • Specjalistyczny Szpital im. Alfreda Sokolowskiego

    Wałbrzych, 58-309
    Poland

    Active - Recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, 00917
    Puerto Rico

    Active - Recruiting

  • Local Institution - 0052

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

  • Local Institution - 0017

    L'Hospitalet de Llobregat, Barcelona 08908
    Spain

    Site Not Available

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Local Institution - 0005

    Barcelona, 08035
    Spain

    Site Not Available

  • Local Institution - 0052

    Barcelona, 08916
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • Local Institution - 0039

    Granada, 18014
    Spain

    Site Not Available

  • Hospital Universitario La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Local Institution - 0038

    Madrid, 28006
    Spain

    Site Not Available

  • CHU de Ourense - H. Santa Maria Nai

    Ourense, 32005
    Spain

    Active - Recruiting

  • Local Institution - 0027

    Ourense, 32005
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Local Institution - 0028

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

  • Local Institution - 0018

    Valencia, 46010
    Spain

    Site Not Available

  • Local Institution - 0063

    Valencia, 46026
    Spain

    Site Not Available

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 90720-3379
    United States

    Active - Recruiting

  • Local Institution - 0048

    San Diego, California 92103-2106
    United States

    Site Not Available

  • Scripps Prebys Cancer Center

    San Diego, California 92103-2106
    United States

    Site Not Available

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Local Institution - 0042

    Miami, Florida 33136
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center-Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Florida Cancer Specialists - NORTH - SCRI - PPDS

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • Florida Cancer Specialists - SOUTH - SCRI - PPDS

    Wellington, Florida 33414
    United States

    Active - Recruiting

  • Local Institution - 0020

    Kansas City, Kansas 66160-8500
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-8500
    United States

    Active - Recruiting

  • Mercy Health - Paducah Medical Oncology and Hematology

    Paducah, Kentucky 42003-7915
    United States

    Active - Recruiting

  • Local Institution - 0012

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Local Institution - 0059

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Atlantic Hematology Oncology

    Morristown, New Jersey 07960-6136
    United States

    Active - Recruiting

  • Local Institution - 0058

    Morristown, New Jersey 07960-6136
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Local Institution - 0057

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Local Institution - 0060

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • James Cancer Hospital and Solove Research Institute - 460 W 10th Ave

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • Local Institution - 0006

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • Local Institution - 0061

    Oklahoma City, Oklahoma 73142-2015
    United States

    Site Not Available

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon 97401-6043
    United States

    Active - Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Texas Oncology - Amarillo

    Amarillo, Texas 79106-1781
    United States

    Active - Recruiting

  • Local Institution - 0022

    Huntsville, Texas 77340-4101
    United States

    Site Not Available

  • North Houston Cancer Clinics - Huntsville

    Huntsville, Texas 77340-4101
    United States

    Active - Recruiting

  • Wheeling Hospital Schiffler Cancer Center

    Wheeling, West Virginia 26003-6379
    United States

    Active - Recruiting

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.