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Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

Primary Purpose

Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bortezomib (Velcade)
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenstrom's Macroglobulinemia focused on measuring bortezomib, Velcade, Waldenstrom's macroglobulinemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Center
  • Beth Israel Deaconess Medical Center

Outcomes

Primary Outcome Measures

To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.

Secondary Outcome Measures

To assess the safety and tolerability of bortezomib in this patient population.

Full Information

First Posted
September 1, 2005
Last Updated
June 23, 2011
Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00142129
Brief Title
Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia
Official Title
Phase II Study of Velcade in Waldenstrom's Macroglobulinemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma
Keywords
bortezomib, Velcade, Waldenstrom's macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bortezomib (Velcade)
Primary Outcome Measure Information:
Title
To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of bortezomib in this patient population.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Treon, MD, MA, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

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