|Closed||Hematologic Malignancies; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD)||Phase III||
The objective of this study is to determine whether pomalidomide is safe and effective in reversing RBC-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis.
- Age ≥18 years
- Myeloproliferative-neoplasm (MPN)-associated myelofibrosis
- Bone marrow biopsy within 6 months
- Inappropriate to receive blood cell or bone marrow allotransplant, erythropoietin and androgenic steroids
- ECOG performance score ≤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
- Prior blood cell or bone marrow allotransplant.
- Use of drugs to treat MPN-associated myelofibrosis ≤30 - 42 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 during the 8 weeks before starting study drug.
- Prior history of cancer, other than due to MPN-associated myelofibrosis unless the subject has been cancer-free ≥5 years. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin prostate cancer stage-1 are allowed at any time.
- HIV-infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
- Prior treatment with pomalidomide.
- Allergic reaction or rash after treatment with thalidomide or lenalidomide
Any of the following laboratory abnormalities:
- Neutrophils <0.5x10e9 /L
- Platelets <25 x 10e9 /L
- Estimated glomerular filtration rate (kidney function) <30 mL/min
- AST and ALT >3.0 x upper limit of normal
- Direct bilirubin ≥3 x ULN;
- Un-controlled 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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