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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00503763
Recruitment Status : Withdrawn (We found out that there is another study on the same issue)
First Posted : July 19, 2007
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):
Meir Medical Center

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

Condition or disease Intervention/treatment Phase
Smoldering Multiple Myeloma Drug: Simvastatin Phase 2

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
Study Start Date : September 2007
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2009

Primary Outcome Measures :
  1. Paraprotein level [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00503763

Sponsors and Collaborators
Meir Medical Center
Principal Investigator: Michael Lishner, MD Meir Medical Center

Responsible Party: Meir Medical Center Identifier: NCT00503763     History of Changes
Other Study ID Numbers: PSMMSS-01
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: July 2007

Keywords provided by Meir Medical Center:
Smoldering multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors