A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS

Prior treatment

• RBC transfusion dependence. Patients may have received only one transfusion series for MDS prior to inclusion

Other illness

• Uncontrolled hypertension
• Uncontrolled cardiovascular disease including angina pectoris or cardiac failure

Lab values

• Baseline Hemoglobin level \> 10.5 g/dl or \<9g/dl
• Transfusion threshold less than 1 g/dl below baseline Hb level
• CMML , if \>10 % BM blasts or WBC\>13.000/mm3
• Renal failure: Creatinine clearance\<40ml/min (using MDRD formula)

Age

• Transfusion threshold (based on age , comorbidities…) \>9g/dl

Other

• Higher risk MDS (IPSS intermediate-2 or high)
• Del 5q
• Pregnancy (positive bettaHCG) or nursing

• Age ≥ 18 years
• MDS according to WHO 2016 criteria, with low or int 1 classical IPSS
• Non-RBC transfusion dependent anemia
• Hb level between 9 and 10.5g/dl (at the center's lab)
• Hb level should be at least 1g/dl higher than the Hb threshold chosen to start RBC transfusions based on age, comorbidities and predicted clinical tolerance of anemia (this transfusion threshold should be chosen between 8 and 9g/dl)
• Serum EPO level \<500U/l
• No other cause of anemia (including iron deficiency, vitamin B12 or B9 deficiency, hemolysis, hypothyroidism….)
• Performance status \<=2