Clinical Trial: Study to Determine the Maximum Tolerated Dose, Safety and Effectiveness of Pomalidomide for Patients With Sickle Cell Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Multi-Center, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety and Effect on Induction of Fetal Hemoglobin of CC-4047 In Subjects With Maximum Tolerated Dose



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse Events [ Time Frame: Up to 169 days ]
    Type, frequency, and severity of adverse events, and relationship of adverse events to pomalidomide
  • Absolute fetal hemoglobin change [ Time Frame: UP to 169 days ]
    Percent of subjects with an absolute increase of 5% in percent fetal hemoglobin levels during study treatment
  • % total hemoglobin [ Time Frame: Up to 169 days ]
    Percent change in total hemoglobin from baseline to highest level
  • Rate of total hemoglobin change [ Time Frame: Up to 169 days ]
    Rate of change of total hemoglobin from baseline to highest level
  • Inflammation markers and cytokines [ Time Frame: Up to 169 days ]
    Change in serum inflammation markers and cytokines from baseline, during and at end of study treatment


Original Secondary Outcome: Same as current

Information By: Celgene

Dates:
Date Received: January 27, 2012
Date Started: August 2007
Date Completion:
Last Updated: December 24, 2013
Last Verified: December 2013