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Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142129
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 27, 2011
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Millennium Pharmaceuticals, Inc.
Information provided by:
Dana-Farber Cancer Institute

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Velcade in Waldenstrom's Macroglobulinemia
Study Start Date : December 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

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

Secondary Outcome Measures :
  1. To assess the safety and tolerability of bortezomib in this patient population.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00142129

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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.
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Principal Investigator: Steven Treon, MD, MA, PhD Dana-Farber Cancer Institute
Layout table for additonal information Identifier: NCT00142129    
Other Study ID Numbers: 03-248
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
Keywords provided by Dana-Farber Cancer Institute:
Waldenstrom's macroglobulinemia
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents