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A Phase II Study of the Combination Bortezomib (Velcade, PS-341), Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia

Phase 2
18 Years
Not Enrolling
Waldenstrom's Macroglobulinemia

Thank you

Trial Information

A Phase II Study of the Combination Bortezomib (Velcade, PS-341), Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia

- This is an open-label study which means both the patient and the doctor will know what
drugs and doses the patient is receiving throughout the study.

- Patients will receive 8 cycles of study treatment with bortezomib, dexamethasone and
rituximab. Each cycle is 21 days long. Therapy is given on the first, fourth, eighth
and eleventh day of each cycle, followed by a 10 day rest period. The first 4 cycles
will be given one after the other. Three months after completing the fourth cycle of
therapy, patients will receive one cycle of therapy every three months for a total of
four more cycles.

- On the first, fourth, eighth and eleventh day of each cycle, the patient will receive
bortezomib and dexamethasone as an intravenous injection through a needle in your vein.
On the eleventh day only, the patient will also receive rituximab as an intravenous
infusion after getting bortezomib and dexamethasone.

- Prior to each infusion of rituximab therapy, the patient will be asked to take some
medications to prevent or reduce side effects of rituximab. These medications are
benadryl, tylenol, and possibly more steroids. The doctor will determine which of
these drugs are appropriate for the individual patient.

- During the rituximab infusion, the patients blood pressure and pulse will be monitored
frequently and the infusion rate may be decreased depending upon the side effects

- After therapy is completed, the patient will be followed every three months for 2 more
years for office visits and laboratory tests to determine how well they are doing and
if the therapy continues to benefit them.

Inclusion Criteria:

- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia (WM)

- No previous therapy for WM

- Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a
minimum IgM level of greater than or equal to 2 times the upper limit of each
institution's normal value

- CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow
cytometric analysis performed up to 3 months prior to enrollment

- Karnofsky performance status > 60

- Life expectancy > 3 months

- AST (SGOT) < 3 x ULN

- ALT (SGPT) < 3 x ULN

- Total bilirubin < 2 x ULN

- Calculated or measured creatinine clearance > 30mL/minute

- Serum sodium > 130 mmol/L

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control

- Male subject agrees to use an acceptable method for contraception for the duration of
the study

Exclusion Criteria:

- Previous therapy for Waldenstrom's macroglobulinemia

- Myocardial infarction within 6 months prior to enrollment or has New York Hospital
Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
conduction system abnormalities.

- Hypersensitivity to dexamethasone, boron or mannitol

- Pregnant or breast-feeding women

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study

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 assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Steven P. Treon, MD, MA, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

February 2009

Related Keywords:

  • Waldenstrom's Macroglobulinemia
  • bortezomib
  • dexamethasone
  • rituximab
  • Waldenstrom Macroglobulinemia



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