Phase II Study of Velcade in Waldenstrom's Macroglobulinemia
18 Years
90 Years
Both
Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma
Trial Information
Phase II Study of Velcade in Waldenstrom's Macroglobulinemia
- 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
Principal Investigator
Steven Treon, MD, MA, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
03-248
NCT ID:
NCT00142129
Start Date:
December 2003
Completion Date:
June 2007
Related Keywords:
- Waldenstrom's Macroglobulinemia
- Lymphoplasmacytic Lymphoma
- bortezomib
- Velcade
- Waldenstrom's macroglobulinemia
- Lymphoma
- Waldenstrom Macroglobulinemia
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Center | Boston, Massachusetts 02115 |
