Trials / Completed
CompletedNCT02237261
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- University Hospital Heidelberg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bendamustine, Bortezomib, Prednisone | Cycle 1 (d1-42) - Induction: Bortezomib: 1.3 mg/m2 s.c.: d1, 4, 8, 11, 22, 25, 29, 32 Bendamustine: 90 mg/m2 iv, d1, 2 Prednison: : 60 mg/m2 po,, d1-4 Cycle 2-9 (d1-28) - Consolidation: Bortezomib: 1.3 mg/m2 s.c.: d1, 8, 15, 22 Bendamustine: 90 mg/m2 iv: d1, 2 Prednison: 60 mg/m2 po: d1-4 |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2018-10-01
- Completion
- 2018-10-01
- First posted
- 2014-09-11
- Last updated
- 2020-10-19
Locations
15 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02237261. Inclusion in this directory is not an endorsement.