Protocol
11-025
Full 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
Purpose
People with myeloproliferative neoplasm (MFN)-associated myelofibrosis often develop anemia (too few functioning red blood cells) and require transfusions of red blood cells. Pomalidomide is an investigational “immunomodulatory” drug that has the potential to reduce the need for blood transfusions in patients with MFN-associated myelofibrosis by altering the response of the immune system.
In this study, researchers want to assess the effectiveness of pomalidomide in patients with MFN-associated myelofibrosis to see if it reduces the number of transfusions needed and to assess its impact on patients’ quality of life. Patients will be randomly assigned to receive pomalidomide or a placebo. Pomalidomide is a capsule that is taken orally (by mouth).
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have MFN-associated myelofibrosis and be dependent on red blood cell transfusions.
- At least 30 days must have passed since receiving prior drug treatment for MFN-associated myelofibrosis and entry into the study.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Ross Levine at 646-888-2767.
Disease(s)
Hematology: Hematologic Disorders
Hematology: Hematologic Malignancies
Hematology: Myelodysplastic Syndrome
Leukemia
Leukemia: Myelodysplastic Syndrome
Leukemia: Myeloproliferative Neoplasm
Locations
Related Diseases
