The Effect of High Dose Simvastatine on Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00281476
• Lead Sponsor: Vejle Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-23
• Study First Submitted QC: 2006-01-23
• Study First Posted: 2006-01-24
• Study Start: 2006-02
• Study Completion: 2007-11
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-31
• Last Update Posted: 2011-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine	8 weeks after treatment start

Secondary Outcome Measures

Name	Time	Method
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