- Patients with low- and Int-1-risk myelodysplastic syndrome
- Documented diagnosis of the following:
Myelodysplastic syndrome lasting ≥ 3 months and < 3 years Disease must not be secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases
- A hemoglobin < 10 g/dL and ≥ 8 g/dL
- History of transfusions < 10 RBC units and must not be RBC transfusion dependent
- 300 ng/mL < serum ferritin < 1,500 ng/mL (Values within 10% difference above 1500 ng/ml or 10% difference below 300 ng/ml may be accepted at the investigator's discretion.
- Endogenous erythropoietin levels < 500 units/L
- Patients with MDS with isolated del(5q)
- Patients who had received prior EPO treatment or other recombinant growth factors regardless of the outcome (Patient who had received prior EPO treatment or other recombinant growth factors for less than 4 weeks and not within 3 months before screening without a documented response are allowed)
- Patients receiving steroids or immunosuppressive therapy for the improvement of hematological parameters (stable steroid treatment for adrenal failure or chronic medical conditions, and intermittent dexamethasone as antiemetics are allowed).
- B12 and folate deficient patients with and without clinical symptoms (patients could be rescreened after successful therapy of B12 and folate deficiency)
- Uncontrolled seizures or uncontrolled hypertension
Other protocol-defined inclusion/exclusion criteria may apply.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|