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Phase II Study of Simvastatin for Relapsed/Refractory Myeloma

NCT01332617 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-12-29

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • James Graham Brown Cancer Center

    collaborator OTHER

  • University of Louisville

    lead OTHER

Principal Investigators

  • Geoffrey Herzig, MD · James Graham Brown Cancer Center- University of Louisville

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2018-02-28
Completion
2019-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01332617 on ClinicalTrials.gov