Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

NCT ID: NCT00142129

Last Updated: 2011-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2007-06-30

Brief 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.

Detailed 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.

Conditions

Waldenstrom's Macroglobulinemia; Lymphoplasmacytic Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Bortezomib (Velcade)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Steven Treon, MD, MA, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

03-248

Identifier Type: -

Identifier Source: org_study_id