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

Primary Purpose

Smoldering Multiple Myeloma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoldering Multiple Myeloma focused on measuring Smoldering multiple myeloma, Simvastatin, Paraprotein

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Paraprotein level

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2007
    Last Updated
    April 15, 2015
    Sponsor
    Meir Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00503763
    Brief Title
    Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
    Acronym
    PSMMSS
    Official Title
    Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2007
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We found out that there is another study on the same issue
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    March 2009 (Anticipated)
    Study Completion Date
    March 2009 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meir Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoldering Multiple Myeloma
    Keywords
    Smoldering multiple myeloma, Simvastatin, Paraprotein

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Primary Outcome Measure Information:
    Title
    Paraprotein level
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Lishner, MD
    Organizational Affiliation
    Meir Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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