The Effect of High Dose Simvastatine on Multiple Myeloma

October 31, 2011 updated by: Vejle Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
Time Frame: 8 weeks after treatment start
8 weeks after treatment start

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine
Time Frame: 8 weeks after start of treatment
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
8 weeks after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Principal Investigator: Torben Plesner, DMSc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 23, 2006

First Submitted That Met QC Criteria

January 23, 2006

First Posted (Estimate)

January 24, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2011

Last Update Submitted That Met QC Criteria

October 31, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-004933-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Simvastatine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe