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A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
Sponsor: Bristol-Myers Squibb
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2023-10-05
Completion Date
2027-12-30
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
Luspatercept
Specified dose on specified days.
Locations (52)
Local Institution - 0051
Los Alamitos, California, United States
Local Institution - 0033
New Haven, Connecticut, United States
Local Institution - 0055
St. Petersburg, Florida, United States
Local Institution - 0056
Wellington, Florida, United States
Local Institution - 0020
Kansas City, Kansas, United States
Local Institution - 0025
Paducah, Kentucky, United States
Local Institution - 0011
Detroit, Michigan, United States
Local Institution - 0059
St Louis, Missouri, United States
Local Institution - 0058
Morristown, New Jersey, United States
Local Institution - 0032
New York, New York, United States
Local Institution - 0054
Eugene, Oregon, United States
Local Institution - 0036
Pittsburgh, Pennsylvania, United States
Local Institution - 0043
Amarillo, Texas, United States
Local Institution - 0022
Huntsville, Texas, United States
Local Institution - 0031
Wheeling, West Virginia, United States
Local Institution - 0003
Milwaukee, Wisconsin, United States
Local Institution - 0016
Leuven, Vlaams Brabant, Belgium
Local Institution - 0008
Roeselare, West-Vlaanderen, Belgium
Local Institution - 0023
Prague, Praha, Hlavní Mesto, Czechia
Local Institution - 0004
Prague, Praha, Hlavní Mesto, Czechia
Local Institution - 0041
Nice, Alpes-Maritimes, France
Local Institution - 0001
Poitiers, Vienne, France
Local Institution - 0026
Angers, France
Local Institution - 0007
Grenoble, France
Local Institution - 0046
Paris, France
Local Institution - 0053
Pierre-Bénite, France
Local Institution - 0044
Tour Cedex01, France
Local Institution - 0013
München, Bavaria, Germany
Local Institution - 0040
Hanover, Lower Saxony, Germany
Local Institution - 0009
Leipzig, Saxony, Germany
Local Institution - 0021
Reggio Calabria, Calabria, Italy
Local Institution - 0062
Naples, Campania, Italy
Local Institution - 0050
Rome, Lazio, Italy
Local Institution - 0015
Pavia, Lombardy, Italy
Local Institution - 0029
Rozzano (MI), Milano, Italy
Local Institution - 0014
Novara, Piedmont, Italy
Local Institution - 0045
Turin, Piedmont, Italy
Local Institution - 0024
Florence, Tuscany, Italy
Local Institution - 0049
Lódz, Lódzkie, Poland
Local Institution - 0010
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0034
Katowice, Poland
Local Institution - 0035
Wałbrzych, Poland
Local Institution - 0047
San Juan, Puerto Rico
Local Institution - 0017
L'Hospitalet de Llobregat, Barcelona, Spain
Local Institution - 0005
Barcelona, Spain
Local Institution - 0052
Barcelona, Spain
Local Institution - 0039
Granada, Spain
Local Institution - 0038
Madrid, Spain
Local Institution - 0027
Ourense, Spain
Local Institution - 0028
Salamanca, Spain
Local Institution - 0018
Valencia, Spain
Local Institution - 0063
Valencia, Spain