Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia
|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)|
|Estimated 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|
|Primary Completion Date :||June 2007|
|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.
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|