Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-03 @ 8:42 PM
Study NCT ID:
NCT02237261
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2014-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma
Sponsor:
University Hospital Heidelberg
Organization:
Study Overview
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).
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BPV
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
-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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-005485-19 | EUDRACT_NUMBER | None | View |