Phase II Study of Simvastatin for Relapsed/Refractory Myeloma
|Myeloma||Drug: Simvastatin,Zoledronic Acid,Bortezomib,Bendamustine,Methylprednisolone.||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma|
- Response to treatment as defined by The International Myeloma Working Group response criteria for multiple myeloma. [ Time Frame: 4 weeks after first dose of simvastatin ]
Response catergories (IMWG):
Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Minor Response (MR), Progressive Disease (PD), Stable Disease, Relapse,Refractory Disease, Overall Response.
- Progression Free Survival (PFS) [ Time Frame: After 1 year of follow-up. ]PFS is measured from date of study enrollment until the date of progressive disease is documented.
- Incidence Rate of Toxicity [ Time Frame: End of study; monitoring during study. ]Decriptive statistics will be provided regarding incidence rates of toxcity. Patients will be monitored for safety throughout the study.
- Overall Survival (OS) [ Time Frame: After 1 year of follow-up ]OS is measured from date of study enrollment until death.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment with combination therapy
Treatment with combination therapy of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine, and Methylprednisolone.
Drug: Simvastatin,Zoledronic Acid,Bortezomib,Bendamustine,Methylprednisolone.
Primary To estimate the overall response rate (ORR) (complete response (CR) + very good partial response (VGPR) + partial response (PR)) of patients with multiple myeloma who have relapsed or are refractory after bortezomib treatment and will now receive a combination therapy of simvastatin, zoledronic acid, bortezomib, bendamustine and methylprednisolone.
To evaluate safety and tolerability of studied therapy.
- To estimate the progression-free Survival (PFS), time to progression (TTP), overall survival (OS) and duration of response (DOR).
- To describe toxicities (frequency and severity) during the treatment. 3 To estimate clinical benefit response (CBR) (ORR + minor response (MR)) and stable disease (SD).
4 Explore factors associated with ORR, PFS, OS, toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332617
|Principal Investigator:||Geoffrey Herzig, MD||James Graham Brown Cancer Center- University of Louisville|