The Effect of High Dose Simvastatine on Multiple Myeloma

This study is not yet open for participant recruitment.

Verified by Vejle Hospital, January 2006

Sponsored by:	Vejle Hospital
Information provided by:	Vejle Hospital
ClinicalTrials.gov Identifier:	NCT00281476

Purpose

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

Condition	Intervention	Phase
Multiple Myeloma	Drug: Simvastatine	Phase I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Effect of High Dose Simvastatine on Multiple Myeloma

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:

Respons estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine
Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine

Estimated Enrollment:	10
Study Start Date:	February 2006
Estimated Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281476

Contacts

Contact: Per Pedersen, MD

+4579406447

petrpe@vgs.vejleamt.dk

Sponsors and Collaborators

Vejle Hospital

Investigators

Principal Investigator:

Torben Plesner, DMSc.

unaffiliated

More Information

Study ID Numbers:	2005-004933-16
Study First Received:	January 23, 2006
Last Updated:	January 23, 2006
ClinicalTrials.gov Identifier:	NCT00281476
Health Authority:	Denmark: Danish Medicines Agency; Denmark: Committee on Biomedical Research Ethics

Keywords provided by Vejle Hospital:

multiple myeloma
statins
bone

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009