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Brief Title: A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
Official Title: A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)
Study ID: NCT06045689
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
Scripps Prebys Cancer Center, San Diego, California, United States
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States
Local Institution - 0042, Miami, Florida, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS, Saint Petersburg, Florida, United States
Florida Cancer Specialists - SOUTH - SCRI - PPDS, Wellington, Florida, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Mercy Health - Paducah Medical Oncology and Hematology, Paducah, Kentucky, United States
Local Institution - 0012, Worcester, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Local Institution - 0059, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Local Institution - 0058, Morristown, New Jersey, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Local Institution - 0057, Durham, North Carolina, United States
Local Institution - 0060, Cleveland, Ohio, United States
James Cancer Hospital and Solove Research Institute - 460 W 10th Ave, Columbus, Ohio, United States
Local Institution - 0061, Oklahoma City, Oklahoma, United States
Oncology Associates of Oregon, P.C., Eugene, Oregon, United States
West Penn Hospital, Pittsburgh, Pennsylvania, United States
Texas Oncology - Amarillo, Amarillo, Texas, United States
North Houston Cancer Clinics - Huntsville, Huntsville, Texas, United States
Wheeling Hospital Schiffler Cancer Center, Wheeling, West Virginia, United States
Froedtert and The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Local Institution - 0016, Leuven, Vlaams Brabant, Belgium
AZ Delta-Brugsesteenweg 90, Roeselare, West-Vlaanderen, Belgium
Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2, Praha 2, Praha, Hlavní Mesto, Czechia
Ustav hematologie a krevni transfuze, Praha, Praha, Hlavní Mesto, Czechia
CHU de Nice Archet I, Nice, Alpes-Maritimes, France
CHU de Poitiers, Poitiers, Vienne, France
CHU d'Angers, Angers, , France
CHU de Grenoble Alpes - Hôpital Michallon, Grenoble cedex 09, , France
AP-HP - Hôpital Saint-Louis, Paris, , France
Hospices Civils de Lyon - Hôpital Lyon Sud, Pierre-Bénite, , France
Hôpital Bretonneau, Tour Cedex01, , France
Local Institution - 0013, München, Bayern, Germany
Studienzentrum am Raschplatz GbR, Hannover, Niedersachsen, Germany
Local Institution - 0037, Gütersloh, Nordrhein-Westfalen, Germany
Local Institution - 0009, Leipzig, Sachsen, Germany
Local Institution - 0021, Reggio Calabria, Calabria, Italy
Local Institution - 0062, Napoli, Campania, Italy
Fondazione PTV Policlinico Tor Vergata, Roma, Lazio, Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardia, Italy
Local Institution - 0029, Rozzano (MI), Milano, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità, Novara, Piemonte, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Piemonte, Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, Toscana, Italy
Local Institution - 0002, Wroclaw, Dolnoslaskie, Poland
Local Institution - 0030, Lublin, Lubelskie, Poland
MTZ Clinical Research Powered by PRATIA - PPDS, Warszawa, Mazowieckie, Poland
Pratia Onkologia Katowice - PRATIA - PPDS, Katowice, , Poland
Local Institution - 0049, Lodz, , Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego, Wałbrzych, , Poland
Auxilio Mutuo Cancer Center, San Juan, , Puerto Rico
Local Institution - 0017, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
Local Institution - 0052, Barcelona, , Spain
Hospital Universitario Virgen de Las Nieves, Granada, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
CHU de Ourense - H. Santa Maria Nai, Ourense, , Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Local Institution - 0063, Valencia, , Spain
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR