NCT00281476

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_1 multiple-myeloma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

First QC Date

January 23, 2006

Last Update Submit

October 31, 2011

Conditions

Multiple Myeloma

Keywords

multiple myelomastatinsbone

Outcome Measures

Primary Outcomes (1)

  • Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine

    8 weeks after treatment start

Secondary Outcomes (2)

  • Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine

    8 weeks after start of treatment

  • Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine

    8 weeks after start of treatment

Interventions

SimvastatineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • multiple myeloma-patients in need of treatment
  • stable og progressive disease
  • age = or \> 18 years
  • performance status \< 3
  • life expectancy \> 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Torben Plesner, DMSc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 24, 2006

Study Start

February 1, 2006

Study Completion

November 1, 2007

Last Updated

November 1, 2011

Record last verified: 2011-10