Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142168
Status:
TERMINATED
Last Update Posted:
2016-04-21
First Post:
2005-09-01
Brief Title:
CC-5013 Lenalidomide and Rituximab in Waldenstroms Macroglobulinemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of CC-5103 and Rituximab in Waldenstroms Macroglobulinemia
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Toxicity
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 determine the number of patients with Waldenstroms macroglobulinemia that will benefit from treatment with CC-5103 lenalidomide and rituximab what the side effects are and how long the benefit will last
Detailed Description:
The study drug CC-5103 lenalidomide will be administered orally once daily for 21 days followed by 7 days of no CC-5103 lenalidomide this will be one 28 day treatment cycle This cycle will repeat itself every 28 days as long as the patient is tolerating the medication and there is no disease progression
Starting on the second week patients will begin treatment with rituximab intravenously once a week for 4 weeks week 2-5 Prior to each treatment patients will receive medications to prevent or reduce the side effects of rituximab benadryl tylenol and possible decadron During the infusion the patients blood pressure and pulse will be monitored frequently and the rate of infusion may decrease depending upon the side effects Blood work will also be performed each week
On week 12 the disease status will be evaluated A physical exam blood test CT scan and bone marrow biopsy may be repeated if necessary to fully evaluate the disease If the disease has gone away completely some tests may be repeated again to confirm this
If the disease has gotten worse after 12 weeks then the patient will be removed from the study
If the disease is stable or getting better the patient will continue with therapy During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be taken daily for 21 days followed by 7 days of rest This 28 day cycle may be repeated until the patient has completed 48 weeks 12 months of treatment as long as the side effects are acceptable and the disease does not progress
All patients will undergo an off-study evaluation that includes a physical exam blood work CT scans and bone marrow biopsy If the patient completes 78 weeks of therapy and the disease does not get worse they will be evaluated every 12 weeks to determine the status of their disease for up to 2 years
Starting on the second week patients will begin treatment with rituximab intravenously once a week for 4 weeks week 2-5 Prior to each treatment patients will receive medications to prevent or reduce the side effects of rituximab benadryl tylenol and possible decadron During the infusion the patients blood pressure and pulse will be monitored frequently and the rate of infusion may decrease depending upon the side effects Blood work will also be performed each week
On week 12 the disease status will be evaluated A physical exam blood test CT scan and bone marrow biopsy may be repeated if necessary to fully evaluate the disease If the disease has gone away completely some tests may be repeated again to confirm this
If the disease has gotten worse after 12 weeks then the patient will be removed from the study
If the disease is stable or getting better the patient will continue with therapy During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be taken daily for 21 days followed by 7 days of rest This 28 day cycle may be repeated until the patient has completed 48 weeks 12 months of treatment as long as the side effects are acceptable and the disease does not progress
All patients will undergo an off-study evaluation that includes a physical exam blood work CT scans and bone marrow biopsy If the patient completes 78 weeks of therapy and the disease does not get worse they will be evaluated every 12 weeks to determine the status of their disease for 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