A Multicenter, Single-arm Study to Assess the Safety, Pharmacokinetics and Efficacy of Lenalidomide in Japanese Subjects With Low- or Intern=Mediate-1-risk Myelodysplastic Syndromes (MDS) Associated With a Deletion 5 (q31-33) Abnormality and Symptomatic Anemia
- Must understand and voluntarily sign an informed consent form.
- Age ≥ 20 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic
Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated
with a deletion 5(q31-33) abnormality
- Symptomatic anemia secondary to MDS defined as:Untransfused Hb level < 10.0 g/dL
and a Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74
or Transfusion dependent anemia
- Pregnant or lactating females.
- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study.
- Prior therapy with lenalidomide.
- Patients with any of the following laboratory abnormalities within 14 days of
starting study drug: Absolute Neutrophil Count (ANC) < 750 cells/μL (0.75 x
10^9/L) Platelet count < 50,000/μL (50x10^9/L) Serum creatinine > 2.5 mg/dL Aspartate
Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3.0 x Upper Limit of