Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence

Inclusion Criteria:

* Age ≥ 18 years
* Myeloproliferative-neoplasm (MPN)-associated myelofibrosis
* RBC-transfusion-dependence (global study):

  * Average RBC-transfusion frequency ≥ 2 units/28 days over at least the 84 days immediately prior to randomization. There must be no interval \> 42 days without ≥ 1 RBC-transfusion.
  * Only RBC-transfusions given when the hemoglobin ≤ 90 g/L³ are scored in

determining eligibility.

* RBC-transfusions due to bleeding are not scored in determining eligibility.
* RBC-transfusions due to chemotherapy-induced anemia are not scored in determining eligibility.

  * Severe anemia (China-specific extension):
* ≥ 2 hemoglobin concentrations ≤ 80 g/L for ≥ 84 days immediately before the day of enrollment.
* No RBC-transfusion within 6 months prior to enrollment.

  * Hemoglobin ≤ 130 g/L at randomization (global study); ≤ 80 g/L at enrollment in the China-specific extension.
  * Bone marrow biopsy within 6 months (global study only).
  * Inappropriate to receive blood cell or bone marrow allotransplant, erythropoietin and androgenic steroids
  * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  * Agree to follow pregnancy precautions as required by the protocol.
  * Agree to receive counseling related to teratogenic and other risks of pomalidomide.
  * Agree not to donate blood or semen.

Exclusion Criteria:

* Prior blood cell or bone marrow allotransplant.
* Use of drugs to treat MPN-associated myelofibrosis ≤ 30 days before starting study drug.
* Treatment with erythropoietin or androgenic steroids ≤ 84 days before starting study drug.
* Anemia due to reasons other than MPN-associated myelofibrosis.
* Pregnant or lactating females.
* More than 10% blasts by bone marrow examination or more than 10% blasts in blood in consecutive measurements spanning at least 8 weeks
* Prior history of malignancies,other than the disease being studied, unless the subject has been free of the malignancy for ≥ 5 years with the following exceptions:

  * Carcinoma in situ of the cervix
  * Carcinoma in situ of the breast
  * Incidental histologic finding of prostate cancer (T 1a or T 1b using TNM \[tumor, nodes, metastasis\] clinical staging system)
* Human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections.
* Prior treatment with pomalidomide.
* Allergic reaction or rash after treatment with thalidomide or lenalidomide
* Any of the following laboratory abnormalities:

  * Neutrophils \< 0.5x10\^9 /L
  * Platelets \< 25 x 10\^9 /L
  * Estimated glomerular filtration rate (kidney function) \< 30 mL/min/1.73 m²
  * Aspartate aminotransferase (AST) and alanine transaminase (ALT) \> 3.0 x upper limit of normal (ULN)
  * Total bilirubin ≥ 4 x ULN;
* Uncontrolled hyperthyroidism or hypothyroidism.
* Deep venous thrombosis (DVT) or pulmonary embolus (PE) \< 6 months before starting study drug
* Clinically-important heart disease within the past 6 months