Myeloma Clinical Trial
Official title:
Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma
The purpose of this study test the hypothesis that the combination of simvastatin and zoledronic acid (for reversal of drug resistance), with bortezomib, high-dose methylprednisolone and bendamustine on a day 1,8 schedule (to reduce toxicity) will be an effective and well-tolerated treatment for relapsed and refractory multiple myeloma
OBJECTIVES
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.
Secondary
1. To estimate the progression-free Survival (PFS), time to progression (TTP), overall
survival (OS) and duration of response (DOR).
2. 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.
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