The effect of high dose Simvastatine on Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- EUCTR2005-004933-16-DK
- Lead Sponsor
- Department of Haematology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10
Multiple myleoma-patients in need of treatment. I.e. with symptoms and/or measurable organ-impairment.
The patients might have stable or progressive disease and ongoing treatment for the disease may continue unchanged during the course of the trial.
Patients must be18 years or older
Patients must have performance status < 3
Patients must have life expectancy > 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Pregnancy
Patients incapable af giving concent personally
Renal insufficiens with creatinine clearence below 25 ml/min
Other active malignant disease than multiple myeloma
Alanine aminotransferasis > 2,5 upper reference limit
Thyroxine below lower reference limit
Known familiar muscle-disease or previous myopati after statin or fibrate treatment
Creatine kinase > 10 x upper reference limit before treatment
Chronic alkoholisme
Medication with drugs with known interactions with simvastatin
Allergy to simvastatin or other substances in the drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation af the effect of high doses af Simvastatin on bone metabolisme and biochemical markers af disease in multiple myeloma;Secondary Objective: ;Primary end point(s): Treatment-respons evaluated by internationally recognized criteria<br>Changes in markers of bone resorption: NTX, ICTP, CTX<br>Changes in markers of bone formation: bone specific alkaline phosphatase<br>Changes in RANKL and OPG<br>Changes in serum-concentration af clone-specific free light-chains (kappa or lambda)<br>Toxicity evaluated by fraction of patients displaying toxicity CTC grade 3 or more
- Secondary Outcome Measures
Name Time Method