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
The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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