Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142129
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2005-09-01
Brief Title:
Bortezomib Velcade in Waldenstroms Macroglobulinemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of Velcade in Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate how tumors in patients with Waldenstroms macroglobulinemia respond to treatment with bortezomib Velcade and to see what effects good and bad it has on the cancer
Detailed Description:
Patients will receive bortezomib intravenously twice weekly for 2 weeks on days 148 and 11 of each cycle A 10-day rest period days 12-21 will follow the 2 weeks of treatment The treatment cycle is repeated up to eight times depending upon the disease response and if the patient is tolerating the drugs
The following procedures will be conducted as part of the treatment monitoring DAY 1 VISIT of each treatment cycle evaluation of disease-related symptoms vital signs and weight and blood tests DAY 4 VISIT of each treatment cycle vital signs and blood work DAY 8 VISIT of each treatment cycle vital signs and blood work DAY 11 VISITof each treatment cycle vital signs blood work and possible CT Scan
Treatment will be discontinued if any of the following occur Disease gets worse severe side-effects or the patient requires other anti-cancer therapy
At the end of the treatment 30 days after the last dose of study drug the patient will have a physical exam vital signs evaluation of disease-related symptoms blood work and CT scan for tumor measurements
Long term follow-up consists of every 3 month clinical visits until disease progression or up to 2 years
The following procedures will be conducted as part of the treatment monitoring DAY 1 VISIT of each treatment cycle evaluation of disease-related symptoms vital signs and weight and blood tests DAY 4 VISIT of each treatment cycle vital signs and blood work DAY 8 VISIT of each treatment cycle vital signs and blood work DAY 11 VISITof each treatment cycle vital signs blood work and possible CT Scan
Treatment will be discontinued if any of the following occur Disease gets worse severe side-effects or the patient requires other anti-cancer therapy
At the end of the treatment 30 days after the last dose of study drug the patient will have a physical exam vital signs evaluation of disease-related symptoms blood work and CT scan for tumor measurements
Long term follow-up consists of every 3 month clinical visits until disease progression or up to 2 years
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