The Effect of High Dose Simvastatine on Multiple Myeloma

Vejle Hospital10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

SimvastatineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine

Time frame: 8 weeks after treatment start

Secondary Outcomes

Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine

Time frame: 8 weeks after start of treatment

Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine

Time frame: 8 weeks after start of treatment

Data from ClinicalTrials.gov

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