Clinical trial · Interventional
Simvastatin as Inhibitor of Cell Adhesion Mediated Drug Resistance in Patients With Refractory Multiple Myeloma.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- antimyeloma activity as measured by the paraprotein
- measure
- toxicity of simvastatin in combination with chemotherapy
Secondary outcomes (1)
- measure
- duration of remission, event free survival, overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDSchmidmaier 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. doi: 10.1182/blood-2003-12-4218. Epub 2004 May 25. PMID 15161667