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The Effect of High Dose Simvastatine on Multiple Myeloma

This study has been completed.
Information provided by:
Vejle Hospital Identifier:
First received: January 23, 2006
Last updated: October 31, 2011
Last verified: October 2011
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
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:

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 ]

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 ]
  • 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00281476

Sponsors and Collaborators
Vejle Hospital
Principal Investigator: Torben Plesner, DMSc.
  More Information Identifier: NCT00281476     History of Changes
Other Study ID Numbers: 2005-004933-16
Study First Received: January 23, 2006
Last Updated: October 31, 2011

Keywords provided by Vejle Hospital:
multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases processed this record on May 23, 2017