Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate how tumors in patients with Waldenstrom's macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects (good and bad) it has on the cancer.

Clinical Trial Description

- 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00142129
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact
Status	Completed
Phase	Phase 2
Start date	December 2003
Completion date	June 2007

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