Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma
NCT02237261 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2020-10-19
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
German Cancer Research Center
collaborator OTHER -
Janssen-Cilag International NV
collaborator INDUSTRY -
Mundipharma Research GmbH & Co KG
collaborator INDUSTRY -
inVentiv Health Clinical
collaborator OTHER -
University Hospital Heidelberg
lead OTHER
Principal Investigators
-
Wolfgang Knauf, MD · Hematology/Oncology,Bethanien hospital, Im Pruefling 17-19, 60389 Frankfurt/M., Germany
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2018-10-31
- Completion
- 2018-10-31
Countries
- Germany
Study Locations
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