Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA

Inclusion Criteria: Patients must meet all of the following criteria to participate in the study: * Myelodysplastic syndrome according to current WHO classification * Age ≥ 18 years * Patients with lower risk MDS according to IPSS classification (LOW, INT-1) without RS who failed to achieved a response or who subsequently relapse after ESA (at least 60000 U EPO-a over at least 12weeks or equivalent), without disease progression (or ineligible to ESA defined by EPO \> 500 UI/l) * Hemoglobin \< 9 gr/dl or Transfusion dependant (at least 3 RBCs in 16 wk in at least 2 transfusion episodes) * Non del(5q) syndrome * Adequat renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance ≥ 40 mL/min (MDRD formula). * Adequat liver function, defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal. * Patient is not known to be refractory to platelet transfusions. * Written informed consent. * Patient must understand and voluntarily sign consent form. * Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements. * ECOG performance status 0-2 at the time of screening. * A FCBP (female of childbearing potential) for this study was defined as a sexually mature woman who: (1) had not undergone a hysterectomy or bilateral oophorectomy; or (2) had not been naturally postmenopausal (amenorrhea following cancer therapy did not rule out childbearing potential) for a…