Brief Title
Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia
Official Title
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
Secondary Outcome
To assess the safety and tolerability of bortezomib in this patient population.
Condition
Waldenstrom's Macroglobulinemia
Intervention
Bortezomib (Velcade)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
December 2003
Completion Date
June 2007
Primary Completion Date
June 2007
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
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Steven Treon, MD, MA, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00142129
Organization ID
03-248
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center
Study Sponsor
Steven Treon, MD, MA, PhD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
June 2011