A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
NCT ID: NCT06045689
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
106 participants
INTERVENTIONAL
2023-10-05
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: erythropoiesis-stimulating agents (ESA) naïve
Luspatercept
Specified dose on specified days.
Cohort 2: ESA relapsed or refractory
Luspatercept
Specified dose on specified days.
Interventions
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Luspatercept
Specified dose on specified days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Participant has had a prior allogeneic or autologous stem cell transplant.
* Participant has known history or diagnosis of AML.
* Participant has uncontrolled hypertension.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Napoli, 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
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA056-1060
Identifier Type: -
Identifier Source: org_study_id