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