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Myelodysplastic/Myeloproliferative Syndromes

Pomalidomide for Myeloproliferative Neoplasms (2465)
A Phase-3, Multi-Center, Randomized, Doubleblind, Placebo-Controlled, Parallel-Group Study To Compare Efficacy And Safety Of Pomalidomide In Subjects With Myeloproliferative Neoplasm, Associated Myelofibrosis And Red Blood Cell-Transfusiondependence
Status Conditions Phase Study ID
Closed Hematologic Malignancies; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD) Phase III 2465
NCT01178281
Summary

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.


Investigator
Joachim Deeg, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Age ≥18 years
  • Myeloproliferative-neoplasm (MPN)-associated myelofibrosis
  • RBC-transfusion-dependence
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
July 25, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.