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The Effect of High Dose Simvastatine on Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

The Effect of High Dose Simvastatine on Multiple Myeloma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

8 weeks after treatment start

Safety Issue:

No

Principal Investigator

Torben Plesner, DMSc.

Investigator Role:

Principal Investigator

Authority:

Denmark: Danish Medicines Agency

Study ID:

2005-004933-16

NCT ID:

NCT00281476

Start Date:

February 2006

Completion Date:

November 2007

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • statins
  • bone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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