Multiple Myeloma
Conditions
Keywords
multiple myeloma, statins, bone
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
Interventions
DRUGSimvastatine
Sponsors
Vejle Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine | 8 weeks after treatment start |
Secondary
| Measure | Time frame |
|---|---|
| Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine | 8 weeks after start of treatment |
| Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine | 8 weeks after start of treatment |
Outcome results
None listed