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Sponsored by: |
Austrian Forum Against Cancer |
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Information provided by: | Austrian Forum Against Cancer |
ClinicalTrials.gov Identifier: | NCT00401804 |
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
Condition | Intervention | Phase |
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Multiple Myeloma Renal Insuficiency |
Drug: Dexamethasone, Bortezomib, Doxorubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Bortezomib-Doxorubicin-Dexamethasone as Treatment for Patients With Multiple Myeloma Presenting With Acute Renal Failure |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Wilhelminenspital Vienna, 1st Med. Department - center for Oncology and Hematology | |
Vienna, Austria, 1160 | |
Universitätsklinik für Innere Medizin I | |
Vienna, Austria, 1090 | |
Medical University of Vienna, Dep. of Internal Medicine I | |
Vienna, Austria, 1090 | |
Dep. of Internal Medicine I, Oncology, SALK - Gemeinnützige Salzburger Landeskliniken | |
Salzburg, Austria, 5020 | |
Landeskrankenhaus Feldkirch | |
Feldkirch, Austria | |
Landeskrankenhaus Leoben | |
Leoben, Austria | |
Klinischen Abteilung für Hämatologie, Medizinische Universitätsklinik Graz | |
Graz, Austria, 8036 | |
Klinikum Kreuzschwestern Wels GmbH | |
Wels, Austria, 4600 | |
Czech Republic | |
FN Brno Interni Hematoonkolog. klinika | |
Brno, Czech Republic, 62500 |
Principal Investigator: | Heinz Ludwig, MD, Univ.Prof. | Austrian Forum agianst Cancer; Wilhelminenspital Vienna, 1st. Med. Department - center for Oncology and Hematology |
Study ID Numbers: | Eudract Number: 2005-003001-85 |
Study First Received: | November 20, 2006 |
Last Updated: | May 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00401804 History of Changes |
Health Authority: | Austria: Ethikkommission; Czech Republic: State Institute for Drug Control; Slovakia: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Croatia: Ministry of Health and Social Care |
Multiple Myeloma renal impairment Velcade |
Dexamethasone Anti-Inflammatory Agents Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal |
Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Glucocorticoids Doxorubicin Protease Inhibitors Multiple Myeloma Kidney Failure, Acute Peripheral Nervous System Agents Lymphoproliferative Disorders Kidney Failure Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Antibiotics, Antineoplastic Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases |
Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Gastrointestinal Agents Vascular Diseases Enzyme Inhibitors Glucocorticoids Doxorubicin Pharmacologic Actions Protease Inhibitors Multiple Myeloma |