Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA
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)
Severe infection or any other uncontrolled severe condition.
Uncontrolled hypertension
Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months.
del(5q) syndrome
Groupe Francophone des Myelodysplasies
Lead sponsor
Celgene
Collaborator