Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant
RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant.
PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.
Multiple Myeloma and Plasma Cell Neoplasm
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload|
- Number of Patients Not Completing Treatment [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity
- Reduction in Liver Iron Concentration After Study Drug [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline (LIC at baseline minus LIC at 6 months). This shows the mean reduction for the 3 subjects treated in this study.
|Study Start Date:||August 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Deferasirox Treated
Includes patients that were treated with deferasirox for 6 months.
20 mg/kg once daily orally for 6 months
Other Name: Exjade
- To evaluate the safety of deferasirox given over 6 months in reducing liver iron concentration in patients with transfusional iron overload after undergoing allogeneic hematopoietic stem cell transplantation.
- To evaluate the efficacy of deferasirox in reducing liver iron overload in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral deferasirox once daily for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed at 4 weeks.
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Linda J. Burns, MD||Masonic Cancer Center, University of Minnesota|