Status:
COMPLETED
Simvastatin as Inhibitor of Cell Adhesion Mediated Drug Resistance in Patients With Refractory Multiple Myeloma.
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In vitro statins, inhibitors of the HMG-CoA-reductase, have been shown to overcome cell adhesion mediated drug resistance at very low concentrations. The purpose of the study is to investigate the in ...
Detailed Description
Multiple Myeloma (MM) is an incurable haematological neoplasm that is characterized by homing, survival, and proliferation of malignant, antibody producing plasma cells in the bone marrow. All clinica...
Eligibility Criteria
Inclusion
- proven multiple myeloma,
- refractory to ongoing chemotherapy (bortezomib,
- bendamustin dexamethasone),
- measurable paraprotein,
- serum protein below 11 g/dl,
- age over 18 years,
- life expectancy greater 6 months,
- contraception in women,
- expected compliance,
- written consent
Exclusion
- severe heart failure,
- not controlled hypertension or diabetes,
- risk factors for rhabdomyolysis,
- creatinin kinase below 30ml/min,
- active liver disease,
- myopathy,
- allergy to simvastatin,
- pregnancy,
- acute infectious disease
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00399867
Start Date
April 1 2005
End Date
April 1 2007
Last Update
December 20 2006
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