Multiple Myeloma
Conditions
Sponsors
Department of Haematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Changes in markers of bone resorption: NTX, ICTP, CTX Changes in markers of bone formation: bone specific alkaline phosphatase Changes in RANKL and OPG Changes in serum-concentration af clone-specific free light-chains (kappa or lambda) Toxicity evaluated by fraction of patients displaying toxicity CTC grade 3 or more | — |
Countries
Denmark
Outcome results
None listed