NCT01332617

Phase II Study of Simvastatin for Relapsed/Refractory Myeloma

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myeloma

Interventions

Type	Name	Description
DRUG	Simvastatin,Zoledronic Acid,Bortezomib,Bendamustine,Methylprednisolone.	1. Simvastatin 80 mg PO daily starting day -2 through day 10. 2. Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly 3. Bortezomib 1.3 mg/m2/day IV bolus on days 3,6 and 10. 4. Bendamustine 100 mg/m2/day IV over 30 minute infusion on days 3 and 10. 5. Methylprednisolone 1g/m2 IV over 30 minutes on days 1 and 8.

Timeline

• Start date: 2011-04-01
• Primary completion: 2018-02-01
• Completion: 2019-02-01
• First posted: 2011-04-11
• Last updated: 2017-12-29