Spots Global Cancer Trial Database for Phase II Study of Simvastatin for Relapsed/Refractory Myeloma

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Trial Identification

Brief Title: Phase II Study of Simvastatin for Relapsed/Refractory Myeloma

Official Title: Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma

Study ID: NCT01332617

Conditions

Myeloma

Interventions

Simvastatin,Zoledronic Acid,Bortezomib,Bendamustine,Methylprednisolone.

Study Description

Brief Summary: 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

Detailed Description: 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.