Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia
In this study, we are trying to find out if the combination of these two drugs is effective in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's macroglobulinemia.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Combination Bortezomib (Velcade PS-341) and Rituximab in Patients With Previously Untreated and Relapsed/Refractory Waldenstrom's Macroglobulinemia|
- Assess the response rate of bortezomib and rituximab (VR) in patients with relapsed or refractory WM. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Evaluate the toxicity of VR in patients with WM [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
- evaluate the time to progression in patients with WM [ Time Frame: Years ] [ Designated as safety issue: No ]
- Study the effect of bortezomib and rituximab on tumor cells in this patient population. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: bortezomib and rituximab
bortezomib and rituximab
Once weekly for 3 weeksDrug: Rituximab
Intravenously once a week for the first and fourth weeks of a cycle
- 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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Irene Ghobrial, MD||Dana-Farber Cancer Institute|