Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
In vitro data indicate that statins affect myeloma cells, mainly by inducing cell death and
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Michael Lishner, MD
Meir Medical Center
Israel: Ministry of Health