Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

Lymphoplasmacytic Lymphoma Clinical Trial

Official title:

Phase II Study of Velcade in Waldenstrom's Macroglobulinemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142129
• Other study ID #: 03-248
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: June 23, 2011
• Start date: December 2003
• Est. completion date: June 2007

Study information

• Verified date: June 2011
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

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

• Lymphoplasmacytic Lymphoma
• Waldenstrom Macroglobulinemia
• Waldenstrom's Macroglobulinemia

Intervention

Drug:
• Bortezomib (Velcade)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
Secondary	To assess the safety and tolerability of bortezomib in this patient population.