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

Smoldering Multiple Myeloma Clinical Trial

— PSMMSS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00503763
• Other study ID #: PSMMSS-01
• Status: Withdrawn
• Phase: Phase 2
• First received: July 18, 2007
• Last updated: April 15, 2015
• Start date: September 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2007
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Smoldering Multiple Myeloma

Intervention

Drug:
• Simvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paraprotein level		18 months