Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström's Macroglobulinemia

Summary

In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab, cyclophosphamide) was shown to be highly effective in patients with WM without inducing major hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed substantial activity as a single agent in WM with only very few side effects when given in a weekly schedule. Based on these observations it is the aim of this study to test whether the efficacy of the well tolerated DRC regime can be further improved by adding Bortezomib.

Conditions

• Waldenström's Macroglobulinemia

Interventions

DRUG

Dexamethasone, Rituximab, Cyclophosphamide

DRUG

Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib

Sponsors & Collaborators

• Centre Hospitalier de Lens (Co-Sponsor)

  collaborator UNKNOWN

• University of Ulm

  lead OTHER

Principal Investigators

• Martin Dreyling, MD · National Co-Coordinating Investigator - Germany University Hospital Großhadern, Munich

• Veronique Leblond, MD · National Co-Coordinating Investigator - Groupe Hospitalier Pitié Salpêtrière France (Paris)

• Pierre Morel, MD · National Co-Coordinating Investigator - Centre Hospitalier Schaffner France (Lens cedex)

• Garcia Sanz, MD · National Co-Coordinating Investigator - University Hospital Salamanca Spain

• Maria da Silva, MD · National Co-Coordinating Investigator - Portuguese Institute of Oncology Portugal

• Meletios Dimopoulos, MD · National Co-Coordinating Investigator - University of Athens School of Medicine Athens Greece

• Eva Kimby, MD · National Co-Coordinating Investigator - Sweden, Denmark, Norway Hematology and Internal Medicine Karolinska Institutet Stockholm Sweden

• Roman Hajek, MD · National Co-Coordinating Investigator - Department of Haematooncology Ostrava Czech Republic

• Wolfram Klapper, MD · Coordinator Pathology (Germany) Department of Pathology Kiel

• Sylvie Chevret · Central Statistics (France)Department of Biostatistics and Medical Information,Hôpital Saint Louis, Paris

• Christian Buske, MD · Coordinating Investigator Germany University Hospital Ulm

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2018-11-30

Completion

2024-04-30

Countries

• Germany

Study Locations