Pomalidomide for Relapse/Refractory Waldenstrom's
The goal of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given to patients with relapsed or refractory WM. The safety of this drug will also be studied.
This is an investigational study. Pomalidomide is FDA approved and commercially available for the treatment of certain types of MM. Its use in this study is investigational.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Pomalidomide in Relapsed or Refractory Waldenstrom Macroglobulinemia|
- Maximum Tolerated Dose (MTD) of Pomalidomide in Participants with Symptomatic Waldenström Macroglobulinemia (WM) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]MTD is defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT) defined as any grade >/= 3 toxicity occurring during the first cycle (28 days).
- Efficacy of Pomalidomide in Participants with Symptomatic Waldenström Macroglobulinemia (WM) [ Time Frame: 30 days after last dose of study drug given. ] [ Designated as safety issue: No ]Efficacy of pomalidomide measured as best response to therapy. Results of blood, urine, and CT and/or MRI scan of the chest, abdomen, and pelvis assessed at end of treatment.
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Pomalidomide Schedule A
Starting dose 1 mg orally for 28 days
Starting dose level 1 mg by mouth on days 1-28 of a 28 day cycle.
Experimental: Pomalidomide Schedule B
Starting dose level 1 mg orally for 21 days then 7 days rest
Starting dose level 1 mg by mouth on days 1-21 of a 28 day cycle.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198067
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sheeba K. Thomas, MD||M.D. Anderson Cancer Center|