Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153933
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2005-09-08
Brief Title:
Bortezomib in Combination With CC-5013 in Patients With RelapsedRefractory Multiple Myeloma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
An Open-Label Phase I Study of the Safety and Efficacy of Bortezomib in Combination With CC-5013 in the Treatment of Subjects With Relapsed and RelapsedRefractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2016-01
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 if this study is to evaluate the side effects of the combination of bortezomib and Revlimid CC-5013 in patients with relapsed and relapsedrefractory multiple myeloma
Detailed Description:
Within 21 days of starting treatment the following tests will be performed physical exam including vital signs ECG neurological examination blood tests urine tests bone marrow aspiration x-rays and MRI or CT scan
Patients will receive bortezomib intravenously on day 148 and 11 followed by 10 days of rest CC-5013 will be given orally on days 1-14 followed by 7-dyas of rest One cycle lasts 21 days This study will evaluate different dose levels of bortezomib and CC-5013 to see which dose level seems to be the best for most people There will be 8 dose levels
Patients will be assigned to a dose level depending upon when they begin the study and how other dose levels have been tolerated by patients that are already on the study Three to six patients will be treated at each dose level and will be observed for one full cycle Depending upon the side effects the dose level will increase stay the same or be decreased by one level for the next group 10 additional patients will be treated at the dose that is thought the best
On day four of the treatment cycle blood tests vital signs and a review of side effects will be performed
On day eight of the the treatment cycle blood tests vital signs review of side effects and an ECG will be performed prior to medication administration A bortezomib level will be taken before bortezomib infusion 15 minutes 12 hour 45 minutes 1 hour 2 hours 4 hours 6 hours 8 hours and 12 hours after the dose Additional blood levels will be collected 24 48 and 72 hours after the dose These blood levels will done during the first cycle only
On day 11 and day 14 of the treatment cycle blood tests vital signs and review of side effects will be performed
After 2 cycles of treatment the doctor will assess how the patients disease is responding to the treatment Additional tests such as bone marrow biopsy x-rays or scans may be performed If the disease is stable or getting better patients will continue to receive repeated cycles of treatment If the disease is getting worse dexamethasone may be added to the treatment cycle
If dexamethasone is added the dosing will start on days 124589 and 11 of the 21-day cycle The disease will then be reassessed after 2 additional cycles If the disease is getting worse the patient will be removed from the study
Once 8 cycles of treatment have been performed the disease will be fully assessed again by blood tests bone marrow biopsy x-rays or scans Again if it is determined that the disease is stable of getting better additional treatment cycles can be performed If the disease is getting worse treatment will be stopped
A follow-up visit will be scheduled one month after the last dose of the study drug and will include physical exam vital signs neurological examination and review of symptoms
Patients will remain on this study as long as the side effects are not too severe and the disease has not progressed
Patients will receive bortezomib intravenously on day 148 and 11 followed by 10 days of rest CC-5013 will be given orally on days 1-14 followed by 7-dyas of rest One cycle lasts 21 days This study will evaluate different dose levels of bortezomib and CC-5013 to see which dose level seems to be the best for most people There will be 8 dose levels
Patients will be assigned to a dose level depending upon when they begin the study and how other dose levels have been tolerated by patients that are already on the study Three to six patients will be treated at each dose level and will be observed for one full cycle Depending upon the side effects the dose level will increase stay the same or be decreased by one level for the next group 10 additional patients will be treated at the dose that is thought the best
On day four of the treatment cycle blood tests vital signs and a review of side effects will be performed
On day eight of the the treatment cycle blood tests vital signs review of side effects and an ECG will be performed prior to medication administration A bortezomib level will be taken before bortezomib infusion 15 minutes 12 hour 45 minutes 1 hour 2 hours 4 hours 6 hours 8 hours and 12 hours after the dose Additional blood levels will be collected 24 48 and 72 hours after the dose These blood levels will done during the first cycle only
On day 11 and day 14 of the treatment cycle blood tests vital signs and review of side effects will be performed
After 2 cycles of treatment the doctor will assess how the patients disease is responding to the treatment Additional tests such as bone marrow biopsy x-rays or scans may be performed If the disease is stable or getting better patients will continue to receive repeated cycles of treatment If the disease is getting worse dexamethasone may be added to the treatment cycle
If dexamethasone is added the dosing will start on days 124589 and 11 of the 21-day cycle The disease will then be reassessed after 2 additional cycles If the disease is getting worse the patient will be removed from the study
Once 8 cycles of treatment have been performed the disease will be fully assessed again by blood tests bone marrow biopsy x-rays or scans Again if it is determined that the disease is stable of getting better additional treatment cycles can be performed If the disease is getting worse treatment will be stopped
A follow-up visit will be scheduled one month after the last dose of the study drug and will include physical exam vital signs neurological examination and review of symptoms
Patients will remain on this study as long as the side effects are not too severe and the disease has not progressed
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