Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440635
Status:
COMPLETED
Last Update Posted:
2013-04-16
First Post:
2007-02-26
Brief Title:
Expanded Access Protocol EAP to Provide Bortezomib to Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
Sponsor:
Janssen-Cilag International NV
Organization:
Janssen-Cilag International NV
Study Overview
Official Title:
International Single-Arm Protocol to Provide Expanded Access to Bortezomib for Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-04
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 provide bortezomib to patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory or have relapse after their last treatment Additional objectives of this study are assess the safety and tolerability of bortezomib and follow the levels of paraprotein in patients receiving bortezomib as a way to followup disease burden
Detailed Description:
Multiple myeloma is uniformly fatal Responses achieved after multiple lines of therapy are normally of short duration Therefore all patients with multiple myeloma will eventually relapse having become refractory to therapy and subsequently will die of their cancer The rationale of this study is that bortezomib as a novel agent may allow additional periods of response due to its different mechanisms of action This is an open-label single-arm multicenter non-comparative study to provide expanded access to bortezomib to patients with multiple myeloma that have received at least two previous lines of therapy and are refractory to or have relapsed after their last treatment Patients will receive treatment with bortezomib 13 mgm2 on day 1 4 8 and 11 of a 3-week cycle No treatment will be administered on the last 10 days of each cycle Treatment may be repeated for up to 8 cycles with possible extension if patient is still responding at the end of the 8 cycle period Bortezomib 13 mgm2 will be administered as an IV bolus
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