Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422799
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2007-01-12
Brief Title:
Combination Bortezomib and Rituximab in Patients With Waldenstroms Macroglobulinemia WM
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of Combination Bortezomib Velcade PS-341 and Rituximab in Patients With Previously Untreated and RelapsedRefractory Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we are trying to find out if the combination of these two drugs is effective in treating Waldenstroms macroglobulinemia WM The combination of these two drugs has not been studied for patients with relapsed or refractory macroglobulinemia The US Food and Drug Administration FDA has approved bortezomib for the treatment of multiple myeloma a cancer that is closely related to Waldenstroms 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 PETCAT 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
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 PETCAT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None