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

Completed · Phase 3 · Has a placebo group

Conditions studied: Primary Myelofibrosis, MPN-associated Myelofibrosis

In brief

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)

Key facts

Study ID

NCT01178281

Run by

Celgene

People needed

267

Starts

2010-09-08

Expected to finish

2018-05-15

Last updated by the study team

2019-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCLA School of Medicine — Los Angeles, California, United States
• University of Florida Shands Cancer Center — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mount Sinai School of Medicine Brookdale University Hospital — Brooklyn, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Ruttenberg Treatment Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Medicine Taussig Cancer Institute — Cleveland, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Avera Hematology and Transplant — Sioux Falls, South Dakota, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Gosford Hospital — Gosford, New South Wales, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Frankston Hospital — Frankston, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Medizinische Universitatklinik Graz — Graz, Austria
• Medizinische Universitat Innsbruck — Innsbruck, Austria
• Medizinische Universitat Wien — Vienna, Austria
• Algemeen Ziekenhuis Sint-Jan — Bruges, Belgium
• Mayo Clinic — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.