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The Effect of High Dose Simvastatine on Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Simvastatine
Sponsored by
Vejle Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, statins, bone

Eligibility Criteria

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

Inclusion Criteria: multiple myeloma-patients in need of treatment stable og progressive disease age = or > 18 years performance status < 3 life expectancy > 3 months Exclusion Criteria: pregnancy patients incapable of giving personally concent renal insufficiens with creatinine clearance below 25 ml/min alanin aminotransferasis > 2,5 x upper reference limit thyroxine below lower reference limit known familiar muscle-disease ar previous myopati creatinine kinase > 10 x upper reference limit medication with drugs with known interactions wiht simvastatine

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine

    Secondary Outcome Measures

    Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine
    Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine

    Full Information

    First Posted
    January 23, 2006
    Last Updated
    October 31, 2011
    Sponsor
    Vejle Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00281476
    Brief Title
    The Effect of High Dose Simvastatine on Multiple Myeloma
    Official Title
    The Effect of High Dose Simvastatine on Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Vejle Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone metabolisme and biochemical markers of disease in Multiple Myeloma

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    multiple myeloma, statins, bone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatine
    Primary Outcome Measure Information:
    Title
    Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
    Time Frame
    8 weeks after treatment start
    Secondary Outcome Measure Information:
    Title
    Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine
    Time Frame
    8 weeks after start of treatment
    Title
    Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine
    Time Frame
    8 weeks after start of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: multiple myeloma-patients in need of treatment stable og progressive disease age = or > 18 years performance status < 3 life expectancy > 3 months Exclusion Criteria: pregnancy patients incapable of giving personally concent renal insufficiens with creatinine clearance below 25 ml/min alanin aminotransferasis > 2,5 x upper reference limit thyroxine below lower reference limit known familiar muscle-disease ar previous myopati creatinine kinase > 10 x upper reference limit medication with drugs with known interactions wiht simvastatine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Torben Plesner, DMSc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of High Dose Simvastatine on Multiple Myeloma

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