Spots Global Cancer Trial Database for Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström's Macroglobulinemia
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Trial Identification
Brief Title: Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström's Macroglobulinemia
Official Title: Efficacy of First Line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for Patients With Waldenström's Macroglobulinemia
Study ID: NCT01788020
Conditions
Study Description
Brief 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.
Detailed Description: Waldenström's macroglobulinemia (WM) is defined by a bone marrow infiltration by lymphoplasmacytic cells and the presence of a monoclonal immunoglobulin (Ig) M gammopathy in the peripheral blood. The clinical understanding of the disease has been greatly improved by the identification of internationally recognized criteria for initiating therapy, the description of an international prognostic index for patients requiring a first-line therapy and the definition of response criteria. These criteria are mainly based on the evolution of serum IgM concentration. However, delayed IgM monoclonal protein responses may cause important difficulties in response assessment. In addition, discrepancies between the kinetics of serum M protein reduction and the clearance of monoclonal B-cells from the bone marrow have been reported. Despite continuing advances in the therapy of WM, the disease remains incurable with a median survival of 5 to 8 years from the time of diagnosis thereby necessitating the development and evaluation of novel treatment approaches.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital Ulm, Ulm, , Germany
Contact Details
Name: Martin Dreyling, MD
Affiliation: National Co-Coordinating Investigator - Germany University Hospital Großhadern, Munich
Role: PRINCIPAL_INVESTIGATOR
Name: Veronique Leblond, MD
Affiliation: National Co-Coordinating Investigator - Groupe Hospitalier Pitié Salpêtrière France (Paris)
Role: PRINCIPAL_INVESTIGATOR
Name: Pierre Morel, MD
Affiliation: National Co-Coordinating Investigator - Centre Hospitalier Schaffner France (Lens cedex)
Role: PRINCIPAL_INVESTIGATOR
Name: Garcia Sanz, MD
Affiliation: National Co-Coordinating Investigator - University Hospital Salamanca Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Maria da Silva, MD
Affiliation: National Co-Coordinating Investigator - Portuguese Institute of Oncology Portugal
Role: PRINCIPAL_INVESTIGATOR
Name: Meletios Dimopoulos, MD
Affiliation: National Co-Coordinating Investigator - University of Athens School of Medicine Athens Greece
Role: PRINCIPAL_INVESTIGATOR
Name: Eva Kimby, MD
Affiliation: National Co-Coordinating Investigator - Sweden, Denmark, Norway Hematology and Internal Medicine Karolinska Institutet Stockholm Sweden
Role: PRINCIPAL_INVESTIGATOR
Name: Roman Hajek, MD
Affiliation: National Co-Coordinating Investigator - Department of Haematooncology Ostrava Czech Republic
Role: PRINCIPAL_INVESTIGATOR
Name: Wolfram Klapper, MD
Affiliation: Coordinator Pathology (Germany) Department of Pathology Kiel
Role: STUDY_CHAIR
Name: Sylvie Chevret
Affiliation: Central Statistics (France)Department of Biostatistics and Medical Information,Hôpital Saint Louis, Paris
Role: STUDY_CHAIR
Name: Christian Buske, MD
Affiliation: Coordinating Investigator Germany University Hospital Ulm
Role: STUDY_DIRECTOR
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