Assessment of Effectiveness and Safety of Luspatercept in Patients Suffering From Lower-risk Myelodysplastic Syndrome.

Inclusion criteria

• . Subject is 18 years of age or older at the time of signing the informed consent form (ICF)
• . Subject is able to understand and voluntarily sign the ICF prior to any study-related assessments/procedures being conducted
• . Subject has documented diagnosis of MDS according to WHO classification that meets IPSS-R classification\[3\] of very low-, low-, or intermediate-risk disease, and the following:
• . Subject must be one of the following:
• . If previously treated with ESAs or G-CSF/granulocyte-macrophage colony-stimulating factor (GM-CSF), both agents must be discontinued ≥ 4 weeks prior to the date of starting treatment with the Investigational medicinal Product (IMP) in this study
• . Required RBC transfusions, as documented by the following criteria:
• . Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
• . A female of childbearing potential (FCBP) for this study is defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy; or (2) is not naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e. had menses at any time in the preceding 24 consecutive months). An FCBP participating in the study must:

Exclusion criteria