Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)

Inclusion Criteria

   - Subject completed a romiplostim study for the treatment of thrombocytopenia in
   subjects with MDS

   - Subject has an Eastern Cooperative Oncology (ECOG) performance status of 0 to 2

   - Subject had a platelet count ≤ 50 x 10^9/L since the final dose of investigational
   product in the parent study

   - Subject or his/her legally acceptable representative provided written informed consent
   before any study-specific procedures were initiated

Exclusion Criteria

   - Subject has been diagnosed with AML or has a blast count ≥ 10% by peripheral blood or
   bone marrow biopsy

   - Subject has a prior history of leukemia

   - Subject has a prior history of bone marrow or stem cell transplantation

   - Subject has a prior malignancy (other than in situ cervical cancer, controlled
   prostate cancer, or basal cell cancer of the skin) unless treated with curative intent
   and without evidence of disease for ≥ 3 years before randomization

   - Subject has active or uncontrolled infections

   - Subject has unstable angina, congestive heart failure [New York Heart Association
   (NYHA) > class II], uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled
   cardiac arrhythmia, or recent (within 1 year) myocardial infarction

   - Subject has a history of arterial thrombosis (eg, stroke or transient ischemic attack)
   in the past year

   - Subject has a history of venous thrombosis that currently requires anti-coagulation
   therapy

   - Subject received interleukin (IL)-11 within 4 weeks of screening

   - Subject previously received a thrombopoietic growth factor (other than romiplostim)

   - Subject has a known hypersensitivity to any recombinant E coli-derived product (eg,
   Infergen®, Neupogen®, Somatropin, Actimmune)

   - Subject is currently enrolled in investigational device or drug study(ies), has not
   yet completed at least 4 weeks since ending investigational device or drug study(ies)
   (other than parent romiplostim study), or subject is receiving other investigational
   agent(s)/device(s)

   - Subject is of child-bearing potential and is evidently pregnant (eg, positive human
   chorionic gonadotropin [HCG] test) or is breast feeding

   - Subject is not using adequate contraceptive precautions

   - Subject has any kind of disorder that compromises his/her ability to give written
   informed consent (and does not have a legally acceptable representative) or is unable
   to comply with study procedures