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Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma — BPV  

Multiple Myeloma Clinical Trial

Official title:
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma Not Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (BPV).

Clinical Trial Summary

The purpose of this study is to improve efficacy of treatment for patients with newly diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone.

Clinical Trial Description

1. Objectives Primary -Therapeutic efficacy of BPV regimen for multiple myeloma as evidenced by the overall response defined as partial response (PR) or better Secondary - to assess overall survival (OS) and progression-free survival (PFS) - to determine response duration - to investigate improvements of renal function - to evaluate safety and toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs) - to analyze the efficacy for genetically defined subgroups of myeloma patients based on iFISH and gene-expression profiling 2. Investigational Medicinal Products Bortezomib Bendamustine both in combination with Prednisone ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02237261
Study type Interventional
Source University Hospital Heidelberg
Contact
Status Completed
Phase Phase 2
Start date November 2014
Completion date October 2018
View Details
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