Trial Information
The Effect of High Dose Simvastatine on Multiple Myeloma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
Outcome Time Frame:
8 weeks after treatment start
Safety Issue:
No
Principal Investigator
Torben Plesner, DMSc.
Investigator Role:
Principal Investigator
Authority:
Denmark: Danish Medicines Agency
Study ID:
2005-004933-16
NCT ID:
NCT00281476
Start Date:
February 2006
Completion Date:
November 2007
Related Keywords:
- Multiple Myeloma
- multiple myeloma
- statins
- bone
- Multiple Myeloma
- Neoplasms, Plasma Cell