Pomalidomide for Relapse/Refractory Waldenstrom's
|ClinicalTrials.gov Identifier: NCT01198067|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Myeloma||Drug: Pomalidomide||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Pomalidomide in Relapsed or Refractory Waldenstrom Macroglobulinemia|
|Actual Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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.
- Maximum Tolerated Dose (MTD) of Pomalidomide in Participants with Symptomatic Waldenström Macroglobulinemia (WM) [ Time Frame: 28 days ]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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|