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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01332617
Study type Interventional
Source University of Louisville
Contact
Status Withdrawn
Phase Phase 2
Start date April 2011
Completion date February 2019

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