Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291538
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2006-02-10
Brief Title:
Comparison of Pharmacokinetics and Pharmacodynamics of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Comparison of Pharmacokinetics and Pharmacodynamics of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2009-02
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 open-label randomised phase I trial bortezomib will be administrated to 2 groups of 10 patients with MM who have inclusion criteria use the extended 2nd line indication either intravenously group 1 10 patients or subcutaneously group 2 10 patients The schedule of administration of bortezomib will be the following 13 mg per square meter of body-surface area twice weekly for 2 weeks followed by 1 week without treatment for up to eight cycles either IV group 1 or SC group 2
The primary objective is to characterize the pharmacokinetics of the 2 routes of administration
The secondary objectives are to characterize the pharmacodynamics 20S proteasome inhibition in whole blood toxicity including cardiac safety and efficacy of the 2 routes of administration
The primary objective is to characterize the pharmacokinetics of the 2 routes of administration
The secondary objectives are to characterize the pharmacodynamics 20S proteasome inhibition in whole blood toxicity including cardiac safety and efficacy of the 2 routes of administration
Detailed Description:
None
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