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The Effect of High Dose Simvastatine on Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00281476
First Posted: January 24, 2006
Last Update Posted: November 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vejle Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281476


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

ClinicalTrials.gov Identifier: NCT00281476     History of Changes
Other Study ID Numbers: 2005-004933-16
First Submitted: January 23, 2006
First Posted: January 24, 2006
Last Update Posted: November 1, 2011
Last Verified: October 2011

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
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors