Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT02237261
Brief 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.
Detailed 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:
NCT02237261
Study Brief:
Protocol Section:
NCT02237261