Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514371
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2007-08-08
Brief Title:
A Study of Tanespimycin KOS-953 in Patients With Relapsed-refractory Multiple Myeloma
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
Phase 23 Randomized Open-Label Clinical Trial of Tanespimycin KOS-953 Plus Bortezomib Comparing Three Doses of Tanespimycin in Patients With Relapsed-Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2015-11
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:
TIME-2
Brief Summary:
This is a phase 23 open label trial for patients with relapsed-refractory multiple myeloma Study agent is tanespimycin KOS-953 at three different dose levels in combination with a fixed dose of bortezomib
Detailed Description:
Phase 23 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens Prior therapy must include bortezomib and lenalidomide Primary objective is to assess the dose-response relationship of objective response rate ORR using EBMTIBMTR criteria of any three dose levels of tanespimycin KOS-953 in combination with bortezomib after four treatment cycles
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KAG-302 | None | None | None |