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

ID#: NCT06045689

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: October 15, 2023

End Date: December 30, 2027

Contact Information:
BMS Study Connect www.BMSStudyconnect.com
First line of the email MUST contain the NCT# and Site#
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.

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 Criteria:

- 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