Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma (PSMMSS)
The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma|
- Paraprotein level [ Time Frame: 18 months ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||March 2009|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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 p.o. /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 investigator.Approximately 15 patients will be enrolled.