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NCT00546988 Clinical Trial

Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years

Multiple Myeloma Clinical Trial

Official title:
Multizentrische Therapiestudie Des Multiplen Myeloms DSMM V Therapieoptimierungs-Studie Der Deutschen Studiengruppe Multiples Myelom für Patienten Bis 60 Jahre im Stadium II/III

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00546988
Other study ID # DSMM V
Secondary ID
Status Recruiting
Phase Phase 3
First received October 17, 2007
Last updated October 17, 2007
Start date October 2001
Est. completion date January 2008

Study information
Verified date October 2007
Source University of Wuerzburg
Contact Hermann Einsele, M.D.
Phone +49/931/201-0
Email einsele_h@klinik.uni-wuerzburg.de
Is FDA regulated No
Health authority Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The study is evaluating whether risk-stratification by the means of a chromosomal aberration provides a tool to discriminate between standard and high risk. Risk-adapted therapy is based on allogeneic stem-cell transplantation for high-risk subjects instead of a second autograft in patients with deletion of chromosome 13 who have an HLA-identical stem cell donor available.

Description:

The DSMM V protocol is to compare a consolidation treatment for standard-risk patients not displaying del(13) at initial diagnosis following two cycles of high-dose melphalan 200 mg/m² each supported by autologous stem cell retransfusion with interferon versus PEG-interferon. Patients with del(13) are screened for availability of a fully HLA-matched related or unrelated donor. If patient's informed consent is obtained additionally, he is scheduled to undergo an allogeneic SCT following the first cycle of high-dose melphalan. All other subjects are to proceed to a second course of high-dose melphalan similar to the standard-risk group. Initial cytoreduction is foreseen with four cycles of anthracycline-dexamethasone combination followed by combination therapy with ifosfamide/epirubicine/etoposide for stem-cell collection.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Primary diagnosis of multiple myeloma

- Salmon-and-Durie stage II or III

- Less than or equal to 60 years

- Signed informed consent

Exclusion Criteria:

- Relevant comorbidities

- Unable to adhere to study protocol

- Pregnancy

- Not received subject's informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• allogeneic stem cell transplant

Locations
Country Name City State
Austria Medizinische Univ.-Klinik Graz Graz
Austria Klin. Abt. für Onkologie, AKH Wien Vienna
Germany Staedtisches Klinikum Augsburg
Germany Charité University Medicine Berlin
Germany Dept. of Hematology/Oncology, Charité Berlin Berlin
Germany University Hospital Erlangen
Germany Krankenhaus Nordwest Frankfurt
Germany Freiburg University Hospital Freiburg
Germany Georg August University Hospital Gottingen
Germany Ernst-Moritz Arndt University Hospital Greifswald
Germany Martin-Luther University Hospital Halle/Saale
Germany University Hospital Eppendorf Hamburg
Germany Hannover Medical School Hannover
Germany Saarland University Hospital Homburg/Saar
Germany Schleswig-Holstein University Hospital Lubeck
Germany Mainz University Hospital Mainz
Germany Dept. of Internal Medicine A, University Muenster Muenster
Germany Dept. of Internal Medicine, Ludwig-Maximilian-University Munich Munich
Germany Klinikum rechts der Isar Munich
Germany Nuremberg Central Hospital Nuremberg
Germany Oldenburg Hospital Oldenburg
Germany University Hospital Regensburg
Germany Diakonissenkrankenhaus Stuttgart
Germany Katharinenhospital Stuttgart
Germany Tubingen University Hospital Tubingen
Germany Dept. of Internal Medicine III, University of Ulm Ulm
Germany Ulm University Hospital Ulm
Germany Horst-Schmidt-Kliniken Wiesbaden
Germany Dept. of Internal Medicine II, University of Wuerzburg Wuerzburg

Sponsors (1)
Lead Sponsor Collaborator
University of Wuerzburg

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate after high-dose therapy one year
Secondary Response rate and treatment-related mortality after allogeneic transplantation one year
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