Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

• 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.

Inclusion criteria

• Clinicopathological diagnosis of Waldenstrom's macroglobulinemia who have failed one first line therapy
• Measurable disease, defined as presence of immunoglobulin M (Ig M) paraprotein with a minimum IgM level of >2 times ULN
• Karnofsky performance status of >60
• Life expectancy of > 3 months
• Baseline platelet count >50,000,000,000/L and ANC of 750,000,000/L
• AST and ALT < 3 x ULN
• Total bilirubin < 2 x ULN
• Calculated or measured creatinine clearance > 30mL/minute
• Serum sodium > 130 mmol/L

Exclusion criteria

• Greater than or equal to Grade 2 peripheral neuropathy
• Hypersensitivity to bortezomib, boron or mannitol
• Prior therapy with Velcade
• Pregnant or lactating women