NCT00503763

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Simvastatin

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-07-19
• Last updated: 2015-04-16