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Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma — PSMMSS  

Smoldering Multiple Myeloma Clinical Trial

Official title:
Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma

Clinical Trial Summary

The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.

Clinical Trial 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 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00503763
Study type Interventional
Source Meir Medical Center
Contact
Status Withdrawn
Phase Phase 2
Start date September 2007
Completion date March 2009
View Details
See also
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