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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02237261 on ClinicalTrials.gov