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The primary objective of the study is to evaluate the activity of BDD in subjects with acute renal failure as measured by· reversal of acute renal failureSecondary objectives· tumor response (complete and partial response)· To evaluate the safety of Bortezomib- Doxorubicin-Dexamethasone in this patient population· to evaluate the activity of Bortezomib- Doxorubicin -Dexamethasone on progression free survival · to evaluate the activity of Bortezomib- Doxorubicin -Dexamethasone on overall survival
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone, Bortezomib, Doxorubicin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| OS |
| Measure | Description | Time Frame |
|---|---|---|
| OR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heinz Ludwig, MD, Univ.Prof. | Austrian Forum agianst Cancer; Wilhelminenspital Vienna, 1st. Med. Department - center for Oncology and Hematology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Feldkirch | Feldkirch | Austria | ||||
| Klinischen Abteilung für Hämatologie, Medizinische Universitätsklinik Graz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20823423 | Derived | Ludwig H, Adam Z, Hajek R, Greil R, Tothova E, Keil F, Autzinger EM, Thaler J, Gisslinger H, Lang A, Egyed M, Womastek I, Zojer N. Light chain-induced acute renal failure can be reversed by bortezomib-doxorubicin-dexamethasone in multiple myeloma: results of a phase II study. J Clin Oncol. 2010 Oct 20;28(30):4635-41. doi: 10.1200/JCO.2010.28.1238. Epub 2010 Sep 7. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000069286 | Bortezomib |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Graz |
| 8036 |
| Austria |
| Landeskrankenhaus Leoben | Leoben | Austria |
| Dep. of Internal Medicine I, Oncology, SALK - Gemeinnützige Salzburger Landeskliniken | Salzburg | 5020 | Austria |
| Medical University of Vienna, Dep. of Internal Medicine I | Vienna | 1090 | Austria |
| Universitätsklinik für Innere Medizin I | Vienna | 1090 | Austria |
| Wilhelminenspital Vienna, 1st Med. Department - center for Oncology and Hematology | Vienna | 1160 | Austria |
| Klinikum Kreuzschwestern Wels GmbH | Wels | 4600 | Austria |
| FN Brno Interni Hematoonkolog. klinika | Brno | 62500 | Czechia |
| 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 |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |