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

Running, not enrolling · Phase 3

Conditions studied: Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT06045689

Run by

Bristol-Myers Squibb

People needed

106

Starts

2023-10-05

Expected to finish

2027-09-29

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal 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

Where it is running

• 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
• 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 - 0049 — Lódz, Lódzkie, Poland

Full record on ClinicalTrials.gov

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