Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years
- Conditions
- Multiple Myeloma
- Interventions
- Biological: allogeneic stem cell transplant
- Registration Number
- NCT00546988
- Lead Sponsor
- University of Wuerzburg
- 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- Primary diagnosis of multiple myeloma
- Salmon-and-Durie stage II or III
- Less than or equal to 60 years
- Signed informed consent
- Relevant comorbidities
- Unable to adhere to study protocol
- Pregnancy
- Not received subject's informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High risk allo allogeneic stem cell transplant Allogeneic stem cell transplantation from an HLA identical related or unrelated donor
- Primary Outcome Measures
Name Time Method Response rate after high-dose therapy one year
- Secondary Outcome Measures
Name Time Method Response rate and treatment-related mortality after allogeneic transplantation one year
Trial Locations
- Locations (28)
Georg August University Hospital
🇩🇪Gottingen, Germany
Ernst-Moritz Arndt University Hospital
🇩🇪Greifswald, Germany
Mainz University Hospital
🇩🇪Mainz, Germany
Dept. of Internal Medicine III, University of Ulm
🇩🇪Ulm, Germany
Klinikum rechts der Isar
🇩🇪Munich, Germany
University Hospital Eppendorf
🇩🇪Hamburg, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
Schleswig-Holstein University Hospital
🇩🇪Lubeck, Germany
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
🇩🇪Munich, Germany
Staedtisches Klinikum
🇩🇪Augsburg, Germany
Charité University Medicine
🇩🇪Berlin, Germany
Saarland University Hospital
🇩🇪Homburg/Saar, Germany
Freiburg University Hospital
🇩🇪Freiburg, Germany
University Hospital
🇩🇪Regensburg, Germany
Dept. of Hematology/Oncology, Charité Berlin
🇩🇪Berlin, Germany
Hannover Medical School
🇩🇪Hannover, Germany
Klin. Abt. für Onkologie, AKH Wien
🇦🇹Vienna, Austria
Dept. of Internal Medicine A, University Muenster
🇩🇪Muenster, Germany
Nuremberg Central Hospital
🇩🇪Nuremberg, Germany
Martin-Luther University Hospital
🇩🇪Halle/Saale, Germany
Tubingen University Hospital
🇩🇪Tubingen, Germany
Oldenburg Hospital
🇩🇪Oldenburg, Germany
Katharinenhospital
🇩🇪Stuttgart, Germany
Diakonissenkrankenhaus
🇩🇪Stuttgart, Germany
Ulm University Hospital
🇩🇪Ulm, Germany
Dept. of Internal Medicine II, University of Wuerzburg
🇩🇪Wuerzburg, Germany
Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Medizinische Univ.-Klinik Graz
🇦🇹Graz, Austria