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

April 15, 2015 updated by: Meir Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Smoldering Multiple Myeloma

Intervention / Treatment

Drug: Simvastatin

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.

Study Type

Interventional

Phase

Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patients fulfilling diagnostic criteria of active MM .(see Appendix I)
Patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma.
Patients on statin treatment on the day of recruitment.
Patients on chemotherapy or receiving steroids.
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).
Patients with second primary malignancy (except for non melanoma skin malignancy) unless they have been disease free for at least five years.
Patients who have a history of alcohol or drug abuse.
Patients who are mentally or physically unable to comply with all aspects of the study.
Participation to an investigational drug trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Paraprotein level Time Frame: 18 months	18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

Principal Investigator: Michael Lishner, MD, Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

March 1, 2009

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria