The Effect of High Dose Simvastatine on Multiple Myeloma

Vejle Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Simvastatine

Study type: Interventional

Funder types: Other

Identifiers

NCT00281476

2005-004933-16

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)