The Effect of High Dose Simvastatine on Multiple Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-11-30

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Simvastatine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Torben Plesner, DMSc.

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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2005-004933-16

Identifier Type: -

Identifier Source: org_study_id