Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00142129|
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom's Macroglobulinemia Lymphoplasmacytic Lymphoma||Drug: Bortezomib (Velcade)||Phase 2|
- Patients will receive bortezomib intravenously twice weekly for 2 weeks on days 1,4,8 and 11 of each cycle. A 10-day rest period (days 12-21) will follow the 2 weeks of treatment. The treatment cycle is repeated up to eight times depending upon the disease response and if the patient is tolerating the drugs.
- The following procedures will be conducted as part of the treatment monitoring: DAY 1 VISIT (of each treatment cycle): evaluation of disease-related symptoms, vital signs and weight and blood tests. DAY 4 VISIT (of each treatment cycle): vital signs and blood work. DAY 8 VISIT (of each treatment cycle): vital signs and blood work. DAY 11 VISIT(of each treatment cycle): vital signs, blood work, and possible CT Scan.
- Treatment will be discontinued if any of the following occur: Disease gets worse, severe side-effects or the patient requires other anti-cancer therapy.
- At the end of the treatment (30 days after the last dose of study drug) the patient will have a physical exam, vital signs, evaluation of disease-related symptoms, blood work and CT scan for tumor measurements.
- Long term follow-up consists of every 3 month clinical visits until disease progression or up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Velcade in Waldenstrom's Macroglobulinemia|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
- To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
- To assess the safety and tolerability of bortezomib in this patient population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142129
|United States, Massachusetts|
|Dana-Farber Cancer Center|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Steven Treon, MD, MA, PhD||Dana-Farber Cancer Institute|