Status:
COMPLETED
Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence
Lead Sponsor:
Celgene
Conditions:
Primary Myelofibrosis
MPN-associated Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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)-associ...
Detailed Description
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 Kingd...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2018
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT01178281
Start Date
September 8 2010
End Date
May 15 2018
Last Update
July 17 2019
Active Locations (87)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
UCLA School of Medicine
Los Angeles, California, United States, 90095
3
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610
4
Mayo Clinic
Jacksonville, Florida, United States, 32224