Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250926
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2005-11-08
Brief Title:
Study of the Combination of Bortezomib Dexamethasone and Rituximab in Patients With Waldenstroms Macroglobulinemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of the Combination Bortezomib Velcade PS-341 Dexamethasone and Rituximab in Patients With Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2016-03
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:
The purpose of this study is to find out if the combination of bortezomib Velcade dexamethasone Decadron and rituximab Rituxan is effective in treating Waldenstroms macroglobulinemia
Detailed Description:
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 experienced
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
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 experienced
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
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