Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years
Multizentrische Therapiestudie Des Multiplen Myeloms DSMM V Therapieoptimierungs-Studie Der Deutschen Studiengruppe Multiples Myelom für Patienten Bis 60 Jahre im Stadium II/III
1 other identifier
interventional
600
2 countries
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Oct 2001
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 17, 2007
CompletedFirst Posted
Study publicly available on registry
October 19, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedOctober 19, 2007
October 1, 2007
October 17, 2007
October 17, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate after high-dose therapy
one year
Secondary Outcomes (1)
Response rate and treatment-related mortality after allogeneic transplantation
one year
Study Arms (4)
Standard risk IFN
NO INTERVENTIONAdministration of interferon alpha as a maintenance treatment following autologous stem cell transplantation
Standard risk PEGIFN
NO INTERVENTIONMaintenance treatment with pegylated interferon following autologous stem cell transplantation
High risk allo
EXPERIMENTALAllogeneic stem cell transplantation from an HLA identical related or unrelated donor
High risk auto
NO INTERVENTIONSecond cycle of high-dose melphalan in subjects without an HLA-identical donor
Interventions
Eligibility Criteria
You may qualify if:
- Primary diagnosis of multiple myeloma
- Salmon-and-Durie stage II or III
- Less than or equal to 60 years
- Signed informed consent
You may not qualify if:
- Relevant comorbidities
- Unable to adhere to study protocol
- Pregnancy
- Not received subject's informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Medizinische Univ.-Klinik Graz
Graz, 8036, Austria
Klin. Abt. für Onkologie, AKH Wien
Vienna, 1090, Austria
Staedtisches Klinikum
Augsburg, 86156, Germany
Dept. of Hematology/Oncology, Charité Berlin
Berlin, 10098, Germany
Charité University Medicine
Berlin, 10117, Germany
University Hospital
Erlangen, 91054, Germany
Krankenhaus Nordwest
Frankfurt, 60488, Germany
Freiburg University Hospital
Freiburg im Breisgau, 79106, Germany
Georg August University Hospital
Göttingen, 37075, Germany
Ernst-Moritz Arndt University Hospital
Greifswald, 17478, Germany
Martin-Luther University Hospital
Halle, 06120, Germany
University Hospital Eppendorf
Hamburg, 20246, Germany
Hannover Medical School
Hanover, Germany
Saarland University Hospital
Homburg/Saar, 66421, Germany
Schleswig-Holstein University Hospital
Lübeck, 23538, Germany
Mainz University Hospital
Mainz, 55131, Germany
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
Munich, 80336, Germany
Klinikum rechts der Isar
Munich, 81675, Germany
Dept. of Internal Medicine A, University Muenster
Münster, 48129, Germany
Nuremberg Central Hospital
Nuremberg, Germany
Oldenburg Hospital
Oldenburg, 26133, Germany
University Hospital
Regensburg, 93053, Germany
Katharinenhospital
Stuttgart, 70173, Germany
Diakonissenkrankenhaus
Stuttgart, 70176, Germany
Tubingen University Hospital
Tübingen, 72076, Germany
Dept. of Internal Medicine III, University of Ulm
Ulm, 89081, Germany
Ulm University Hospital
Ulm, 89081, Germany
Horst-Schmidt-Kliniken
Wiesbaden, 65199, Germany
Dept. of Internal Medicine II, University of Wuerzburg
Würzburg, 97070, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hermann Einsele, M.D.
Wuerzburg University Hospital, Dept. of Hematology and Oncology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 17, 2007
First Posted
October 19, 2007
Study Start
October 1, 2001
Study Completion
January 1, 2008
Last Updated
October 19, 2007
Record last verified: 2007-10