Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063726
Status:
COMPLETED
Last Update Posted:
2012-01-13
First Post:
2003-07-02
Brief Title:
A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Millennium Pharmaceuticals Inc
Study Overview
Official Title:
An International Non-Comparative Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039
Status:
COMPLETED
Status Verified Date:
2012-01
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 of this study is to allow patients to receive VELCADE bortezomib for Injection who experienced progressive diseasePD while receiving high-dose dexamethasone from the M34101-039 study
Detailed Description:
The rationale for Amendment 2 is 2-fold First it is intended that this study serve as a rollover protocol for patients who experience progressive disease PD after receiving the comparator treatment high-dose dexamethasone in MPI Study M34101-039 thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE bortezomib for Injection formerly known as MLN341 LDP-341 and PS-341
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