The Effect of High Dose Simvastatine on Multiple Myeloma

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simvastatine

Drug

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

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Important dates

Study start: 2006
Study completion: 2007
First posted: Jan 24, 2006
Registry last updated: Nov 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed