Overcoming Chemotherapy Resistance In Refractory Multiple Myeloma With Simvastatin and Zoledronic Acid
The purpose of this study is to examine the effect of simvastatin and zoledronic acid on M-protein and/or free light chains when added to conventional chemotherapy for the treatment of multiple myeloma patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Overcoming Chemotherapy Resistance In Refractory Multiple Myeloma With Simvastatin and Zoledronic Acid|
- Change in Paraprotein level and free light chain (FLC) ratio from Baseline measurement [ Time Frame: 4 weeks after treatment begins ] [ Designated as safety issue: No ]The effect of simvastatin and zolendronic acid on M-Protein and FLC ratio will be measured 4 weeks after treatment begins, then every 4 weeks until progression of disease.
- Overall survival [ Time Frame: At start of year 2 of follow-up on all surviving participants ] [ Designated as safety issue: Yes ]OS(Overall survival) is measured from date of study enrollment until death.
- Duration of response [ Time Frame: Year 1 follow up visits occur monthly ] [ Designated as safety issue: No ]Response will be accessed by one of the study investigators at each monthly follow up visit during year one.
- Progression Free Survival (PFS) [ Time Frame: At start of year 2 follow up on all surviving participants ] [ Designated as safety issue: Yes ]Study will estimate PFS when there is one year of follow up data for all surviving participants
- Duration of response [ Time Frame: Year 2 follow up visit occur every three months ] [ Designated as safety issue: No ]Response will be assessed by one of the study investigators at each three month follow up visit for Year 2
- Duration of response [ Time Frame: Year 3-5 follow up visit occurs every six months ] [ Designated as safety issue: No ]Response will be assessed by one of the study investigators at each six month follow up visit for Year 3-5
- Incidence Rate of Toxicity [ Time Frame: Every 12 months up to one month after treatment completion ] [ Designated as safety issue: Yes ]Descriptive statistics will be provided regarding incidence rates of toxicity. Patients will be monitored for safety throughout the study.
- Comparison of Quality of Life scores [ Time Frame: Up to 2 months after last treatment has been completed ] [ Designated as safety issue: No ]The QOL scores taken at the start of the study and every 4 months after treatment starts will be analyzed using Wilcoxon test for paired differences
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Study Arm
Drug: Simvastatin and zoledronic acid
Other Name: Zocor
We hypothesize that the addition of simvastatin and zoledronic acid to bortezomib, thalidomide, melphalan or dexamethasone based regimens will decrease drug resistance when treating refractory multiple myeloma. We hypothesize that the addition of simvastatin and zoledronic acid will not increase the chemotherapy toxicity significantly and will be tolerable for patients. We believe simvastatin and zoledronic acid have antitumor properties and will contribute to reversal of resistance. Treatment will be significantly enhanced when these agents are combined
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772719
|Contact: David P Figg, BS||502-562-562-4006|
|Contact: Cesar Rodriguez, MD||502-562-4363|
|United States, Kentucky|
|James Graham Brown Cancer Center||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: David P Figg 502-562-4006|
|Contact: Cesar Rodriguez 502-562-4363|
|Principal Investigator: Geoffrey Herzig, MD|
|Sub-Investigator: Roger Herzig, MD|
|Principal Investigator:||Cesar Rodriguez, MD||Dept. of Med Admin.|