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.
3 other identifiers
interventional
30
0 countries
N/A
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 multiple-myeloma
Started Apr 2005
Shorter than P25 for phase_2 multiple-myeloma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 14, 2006
CompletedFirst Posted
Study publicly available on registry
November 15, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedDecember 20, 2006
November 1, 2006
November 14, 2006
December 19, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
antimyeloma activity as measured by the paraprotein
toxicity of simvastatin in combination with chemotherapy
Secondary Outcomes (1)
duration of remission, event free survival, overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.1182/blood-2003-12-4218. Epub 2004 May 25.
PMID: 15161667BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bertold Emmerich, MD, PhD
Medizinische Klinik Innenstadt, University Munich
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 14, 2006
First Posted
November 15, 2006
Study Start
April 1, 2005
Study Completion
April 1, 2007
Last Updated
December 20, 2006
Record last verified: 2006-11