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The present study will be a multicenter, prospective phase II-study investigating safety and efficacy of the combination of auto-allo tandem stem cell transplantation in patients with multiple myeloma and age of >_60 years, followed by maintenance therapy with low-dose Thalidomide and Donor Lymphocyte Infusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI |
|
| B | Active Comparator | Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI | Procedure | *Multiple myeloma
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival 4 years after auto-allo/ auto-auto Tandem-SCT. Any of the following will be considered an endpoint event: recurrence or progression of primary disease, disease related mortality, or treatment related mortality. | four years after Tandem stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute GvHD | day +100 after allogeneic stem cell transplantation | |
| Incidence of chronic GvHD | at one year and at two years after allogeneic stem cell transplantation | |
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Inclusion Criteria:
Exclusion Criteria:
More than eight chemotherapy cycles prior to registration
severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
Positive serology for HIV
Pregnant or lactating women
Participation in another trial at the time of registration
Preceding autologous stem cell transplantation
age > 61 years
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| Name | Affiliation | Role |
|---|---|---|
| Nicolaus Kroeger, Prof. Dr. | University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Augsburg | Augsburg | 86156 | Germany | |||
| Charité |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37941409 | Derived | Kroger N, Wulf G, Hegenbart U, Burchert A, Stelljes M, Gagelmann N, Brecht A, Kaufmann M, Muller L, Ganser A, Wolf D, Bethge W, Bornhauser M, Kiehl M, Wagner EM, Schmid C, Reinhardt HC, Kobbe G, Salwender H, Heinicke T, Kropff M, Heinzelmann M, Ayuk F, Trumper L, Neubauer A, Volp A, Kluychnikov E, Schonland S, Wolschke C. Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective, phase II study. Haematologica. 2024 May 1;109(5):1469-1479. doi: 10.3324/haematol.2023.282920. |
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|
| auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide | Procedure | *Multiple myeloma
|
|
| Toxicity of conditioning regimen and of maintenance therapy |
| Throughout conditioning regimen and maintenance therapy |
| cumulative incidence of relapse | four years after Tandem stem cell transplantation |
| Disease related mortality | four years after allogeneic stem cell transplantation |
| Treatment related mortality | four years after allogeneic stem cell transplantation |
| overall survival | four years after allogeneic stem cell transplantation |
| Berlin |
| 12203 |
| Germany |
| Universitätsklinikum Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen | Essen | 45122 | Germany |
| Klinikum Frankfurt (Oder) GmbH | Frankfurt (Oder) | 15236 | Germany |
| Universitätsklinikum Göttingen | Göttingen | 37075 | Germany |
| Universitätsklinikum Greifswald | Greifswald | 17475 | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06097 | Germany |
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Marburg | Marburg | 35032 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | 70376 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Deutsche Klinik für Diagnostik | Wiesbaden | 65191 | Germany |
| Horst Schmidt Kliniken GmbH | Wiesbaden | 65199 | 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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| ID | Term |
|---|---|
| D008283 | Maintenance |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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