Multiple Myeloma Clinical Trial
Official title:
The Effect of High Dose Simvastatine on Multiple Myeloma
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
Status | Completed |
Enrollment | 10 |
Est. completion date | November 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Vejle Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine | 8 weeks after treatment start | No | |
Secondary | Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine | 8 weeks after start of treatment | No | |
Secondary | Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine | 8 weeks after start of treatment |
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