Simvastatin as Inhibitor of Cell Adhesion Mediated Drug Resistance in Patients With Refractory Multiple Myeloma.

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Simvastatin

Criteria

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