Multiple Myeloma Clinical Trial
Official title:
Determination of the Efficacy and Feasibility of Simvastatin as Inhibitor of Cell Adhesion Mediated Drug Resistance in Patients With Refractory Multiple Myeloma – a Phase II Clinical Trial.
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 vivo efficacy of simvastatin as inhibitor of cell adhesion mediated drug resistance. Patients refractory to ongoing chemotherapy will receive concomitantly simvastatin and response will be monitored by paraprotein levels
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich |
Schmidmaier R, Baumann P, Simsek M, Dayyani F, Emmerich B, Meinhardt G. The HMG-CoA reductase inhibitor simvastatin overcomes cell adhesion-mediated drug resistance in multiple myeloma by geranylgeranylation of Rho protein and activation of Rho kinase. Blood. 2004 Sep 15;104(6):1825-32. Epub 2004 May 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | antimyeloma activity as measured by the paraprotein | |||
Primary | toxicity of simvastatin in combination with chemotherapy | |||
Secondary | duration of remission, event free survival, overall survival |
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