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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.
 
ClinicalTrials.gov Identifier: NCT00142129
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 27, 2011
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Millennium Pharmaceuticals, Inc.
Information provided by:
Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE December 2003
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
To assess the safety and tolerability of bortezomib in this patient population.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia
Official Title  ICMJE Phase II Study of Velcade in Waldenstrom's Macroglobulinemia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Waldenstrom's Macroglobulinemia
  • Lymphoplasmacytic Lymphoma
Intervention  ICMJE Drug: Bortezomib (Velcade)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 1, 2005)
27
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00142129
Other Study ID Numbers  ICMJE 03-248
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Millennium Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Steven Treon, MD, MA, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP