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

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.

Inclusion Criteria:

1. Patients fulfilling the criteria of SMM. (see Appendix I)
2. Patients with progressive smoldering Myeloma. (see Appendix II)
3. Age 18-80 years.
4. Signed informed consent prior to patient recruitment.

Exclusion Criteria:

1. Patients fulfilling diagnostic criteria of active MM .(see Appendix I)

2. Patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma.

3. Patients on statin treatment on the day of recruitment.

4. Patients on chemotherapy or receiving steroids.

5. Patients with any contraindication to statin treatment:

   • Known intolerance or hypersensitivity to statin.
   • SGOT or SGPT above 1.5 times of upper normal level (UNL).
   • CPK above UNL
   • Concomitant treatment with macrolides and or antifungal agents (ketoconazole)
   • Creatinine level above 1.5 mg%
   • Any severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).

6. Patients with second primary malignancy (except for non melanoma skin malignancy) unless they have been disease free for at least five years.

7. Patients who have a history of alcohol or drug abuse.

8. Patients who are mentally or physically unable to comply with all aspects of the study.

9. Participation to an investigational drug trial