Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503763
Status:
WITHDRAWN
Last Update Posted:
2015-04-16
First Post:
2007-07-18
Brief Title:
Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
Sponsor:
Meir Medical Center
Organization:
Meir Medical Center
Study Overview
Official Title:
Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
Status:
WITHDRAWN
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We found out that there is another study on the same issue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSMMSS
Brief Summary:
The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma
Detailed Description:
In vitro data indicate that statins affect myeloma cells mainly by inducing cell death and growth suppression
This is a national multicenter phase IIa single arm not controlled open label clinical trial of Simvastatin 80mg po day in a population of patients with progressive SMM Patients will be treated with Simvastatin 40 mg and if no side effect will be seen the dose will be escalated to 80 mg for up to 18 months All further treatment decisions after completion of the study are at the discretion of the investigatorApproximately 15 patients will be enrolled
This is a national multicenter phase IIa single arm not controlled open label clinical trial of Simvastatin 80mg po day in a population of patients with progressive SMM Patients will be treated with Simvastatin 40 mg and if no side effect will be seen the dose will be escalated to 80 mg for up to 18 months All further treatment decisions after completion of the study are at the discretion of the investigatorApproximately 15 patients will be enrolled
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