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The Effect of High Dose Simvastatine on Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00281476
First received: January 23, 2006
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of High Dose Simvastatine on Multiple Myeloma

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine [ Time Frame: 8 weeks after treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine [ Time Frame: 8 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine [ Time Frame: 8 weeks after start of treatment ]

Estimated Enrollment: 10
Study Start Date: February 2006
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

Sponsors and Collaborators
Vejle Hospital
Investigators
Principal Investigator: Torben Plesner, DMSc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00281476     History of Changes
Other Study ID Numbers: 2005-004933-16
Study First Received: January 23, 2006
Last Updated: October 31, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Committee on Biomedical Research Ethics

Keywords provided by Vejle Hospital:
multiple myeloma
statins
bone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013