Back to resultsThe 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
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, statins, bone
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
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
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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