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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia.
Steven P. Treon, MD, MA, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|