Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.
Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.
The purpose of this clinical experience study is to determine whether CC-5013 is safe and
 effective (to include studying the process by which a drug is absorbed, distributed,
 metabolized, and eliminated by the body [pharmacokinetics]) in Japanese subjects with low- or
 intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33)
 abnormality and symptomatic anemia.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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 Normal (ULN)