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

This study has been withdrawn prior to enrollment.
(We found out that there is another study on the same issue)
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00503763
First received: July 18, 2007
Last updated: May 4, 2009
Last verified: July 2007
  Purpose

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


Condition Intervention Phase
Smoldering Multiple Myeloma
Drug: Simvastatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

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

Estimated Enrollment: 15
Study Start Date: September 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503763

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

No publications provided

ClinicalTrials.gov Identifier: NCT00503763     History of Changes
Other Study ID Numbers: PSMMSS-01
Study First Received: July 18, 2007
Last Updated: May 4, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Smoldering multiple myeloma
Simvastatin
Paraprotein

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

ClinicalTrials.gov processed this record on October 23, 2014