Primary Myelofibrosis Clinical Trial
Official title:
A Phase-3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy and Safety of Pomalidomide in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Red Blood Cell-Transfusion-Dependence
The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only)
The multicenter global study was conducted in 15 countries including Australia, Austria,
Belgium, Canada, China, France, Germany, Italy, Japan, the Netherlands, Russia, Spain,
Sweden, the United Kingdom, and the United States. The global study enrolled participants
with myeloproliferative neoplasm (MPN)-associated myelofibrosis and
RBC-transfusion-dependence. Participants were randomly assigned to receive pomalidomide or
placebo in a blinded fashion.
In most countries participating in the global study, RBC-transfusions are typically given for
a hemoglobin level <80-90 g/L. In China, RBC-transfusions are rarely given unless the
hemoglobin level is <60 g/L. Consequently, few Chinese with MPN-associated myelofibrosis meet
RBC-transfusion-dependence criteria of the global study. A China-specific extension was
developed to test the ability of pomalidomide to improve severe anemia (defined as a
hemoglobin < 80 g/L for ≥ 84 days in persons not receiving RBC-transfusions).
The China-specific extension study consisted of a single-arm, open-label study in adults with
MPN-associated myelofibrosis and severe anemia not receiving RBC transfusions with the
objective of describing the frequency of anemia response.
The Global (intent-to-treat [ITT] and safety) population in the main study and the China
extension (ITT and safety) population are mutually exclusive.
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