Text Size

Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Millennium Pharmaceuticals, Inc.
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00142129
First received: September 1, 2005
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Waldenstrom's Macroglobulinemia
Lymphoplasmacytic Lymphoma
 Drug: Bortezomib (Velcade)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Velcade in Waldenstrom's Macroglobulinemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

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.

Estimated Enrollment: 27
Study Start Date: December 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142129

Locations
United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Steven Treon, MD, MA, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00142129     History of Changes
Other Study ID Numbers: 03-248
Study First Received: September 1, 2005
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
bortezomib
Velcade
Waldenstrom's macroglobulinemia

Additional relevant MeSH terms:
Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013