Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452569
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2007-03-23
Brief Title:
Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
Randomised Controlled Open-labelled Multi-centre Comparison of Thalidomide Versus High-dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2019-11
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:
OPTIMUM
Brief Summary:
The primary objective is to compare the time to progression TTP of three daily doses of thalidomide 100 200 and 400 mg with high-dose dexamethasone in relapsed refractory multiple myeloma MM patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity
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