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Phase II Study of Velcade in Waldenstrom's Macroglobulinemia

Phase 2
18 Years
90 Years
Not Enrolling
Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma

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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:


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


United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

June 2007

Related Keywords:

  • Waldenstrom's Macroglobulinemia
  • Lymphoplasmacytic Lymphoma
  • bortezomib
  • Velcade
  • Waldenstrom's macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Center Boston, Massachusetts  02115