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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard risk IFN | No Intervention | Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation | |
| Standard risk PEGIFN | No Intervention | Maintenance treatment with pegylated interferon following autologous stem cell transplantation | |
| High risk allo | Experimental | Allogeneic stem cell transplantation from an HLA identical related or unrelated donor |
|
| High risk auto | No Intervention | Second cycle of high-dose melphalan in subjects without an HLA-identical donor |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic stem cell transplant | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate after high-dose therapy | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate and treatment-related mortality after allogeneic transplantation | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hermann Einsele, M.D. | Contact | +49/931/201-0 | 70015 | einsele_h@klinik.uni-wuerzburg.de |
| Stefan Knop, M.D. | Contact | +49/931/201-0 | 70368 | knop_s@klinik.uni-wuerzburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Hermann Einsele, M.D. | Wuerzburg University Hospital, Dept. of Hematology and Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Univ.-Klinik Graz | Recruiting | Graz | 8036 | Austria |
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| Label | URL |
|---|---|
| Site of the German association of the leading research groups in lymphoid malignancies | View source |
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| Klin. Abt. für Onkologie, AKH Wien | Recruiting | Vienna | 1090 | Austria |
|
| Staedtisches Klinikum | Recruiting | Augsburg | 86156 | Germany |
| Dept. of Hematology/Oncology, Charité Berlin | Recruiting | Berlin | 10098 | Germany |
|
| Charité University Medicine | Recruiting | Berlin | 10117 | Germany |
|
| University Hospital | Recruiting | Erlangen | 91054 | Germany |
| Krankenhaus Nordwest | Recruiting | Frankfurt | 60488 | Germany |
| Freiburg University Hospital | Recruiting | Freiburg im Breisgau | 79106 | Germany |
|
| Georg August University Hospital | Recruiting | Göttingen | 37075 | Germany |
| Ernst-Moritz Arndt University Hospital | Recruiting | Greifswald | 17478 | Germany |
| Martin-Luther University Hospital | Recruiting | Halle | 06120 | Germany |
|
| University Hospital Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| Hannover Medical School | Recruiting | Hanover | Germany |
|
| Saarland University Hospital | Recruiting | Homburg/Saar | 66421 | Germany |
|
| Schleswig-Holstein University Hospital | Recruiting | Lübeck | 23538 | Germany |
| Mainz University Hospital | Recruiting | Mainz | 55131 | Germany |
| Dept. of Internal Medicine, Ludwig-Maximilian-University Munich | Recruiting | Munich | 80336 | Germany |
|
| Klinikum rechts der Isar | Recruiting | Munich | 81675 | Germany |
| Dept. of Internal Medicine A, University Muenster | Recruiting | Münster | 48129 | Germany |
|
| Nuremberg Central Hospital | Recruiting | Nuremberg | Germany |
|
| Oldenburg Hospital | Recruiting | Oldenburg | 26133 | Germany |
|
| University Hospital | Recruiting | Regensburg | 93053 | Germany |
| Katharinenhospital | Recruiting | Stuttgart | 70173 | Germany |
|
| Diakonissenkrankenhaus | Recruiting | Stuttgart | 70176 | Germany |
| Tubingen University Hospital | Recruiting | Tübingen | 72076 | Germany |
|
| Dept. of Internal Medicine III, University of Ulm | Recruiting | Ulm | 89081 | Germany |
|
| Ulm University Hospital | Recruiting | Ulm | 89081 | Germany |
| Horst-Schmidt-Kliniken | Recruiting | Wiesbaden | 65199 | Germany |
|
| Dept. of Internal Medicine II, University of Wuerzburg | Recruiting | Würzburg | 97070 | Germany |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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