Phase II Study of Combination Bortezomib (Velcade PS-341) and Rituximab in Patients With Previously Untreated and Relapsed/Refractory Waldenstrom's Macroglobulinemia
- Participants will receive 6 cycles of the study treatment with bortezomib and
rituximab. Each cycle is 28 days long (4 weeks).
- Participants will receive Rituximab intravenously once a week for the first and fourth
cycles only. Participants will receive bortezomib once a week for three weeks on and
one week off every cycle, for a total of 6 cycles.
- During the rituximab infusion, the participants blood pressure and pulse will be
monitored frequently. The rate of infusion may be decreased depending upon the side
effects that are experienced.
- Blood samples will be collected before the first dose and on follow up with every
cycle. Blood counts will also be performed every week.
- Routine physical exams will be performed at each evaluation. A PET/CAT scan of the
chest, abdomen and pelvis at the end of treatment. This scan is required to assess the
response of the participants disease.
- In order to learn more on how bortezomib and rituximab affect WM, a bone marrow biopsy
will be performed.
- We anticipate that participants will complete the active therapy over a period of 6
cycles provided that they are benefiting from therapy and have not had any serious side
effects. The participant will be followed every three months for 2 years for office
visits and laboratory tests.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the response rate of bortezomib and rituximab (VR) in patients with relapsed or refractory WM.
Irene Ghobrial, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|