NCT00422799

Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)

Phase II Study of Combination Bortezomib (Velcade PS-341) and Rituximab in Patients With Previously Untreated and Relapsed/Refractory Waldenstrom's Macroglobulinemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Waldenstrom's Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Bortezomib	Once weekly for 3 weeks
DRUG	Rituximab	Intravenously once a week for the first and fourth weeks of a cycle

Timeline

• Start date: 2006-08-30
• Primary completion: 2015-10-09
• Completion: 2015-10-09
• First posted: 2007-01-17
• Last updated: 2020-10-27
• Results posted: 2018-01-26

Locations

1 site across 1 country: United States