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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:
Contact: Heinz Ludwig, MD, Univ. Prof. | +43-1-49150 ext 2101 | heinz.ludwig@wienkav.at |
Contact: Corinne Grafl, Studynurse | +43-1-49150 ext 2164 | corinne.grafl@wienkav.at |
Austria | |
Wilhelminenspital Vienna, 1st Med. Department - center for Oncology and Hematology | Recruiting |
Vienna, Austria, 1160 | |
Contact: Heinz Ludwig, MD, Univ. Prof. +43-1-49150 ext 2101 heinz.ludwig@wienkav.at | |
Contact: Corinne Grafl, studynurse +43-1-49150 ext 2164 corinne.grafl@wienkav.at | |
Principal Investigator: Heinz Ludwig, MD, Univ. Prof. | |
Universitätsklinik für Innere Medizin I | Recruiting |
Vienna, Austria, 1090 | |
Principal Investigator: Heinz Gisslinger, MD, Univ. Prof. | |
Medical University of Vienna, Dep. of Internal Medicine I | Recruiting |
Vienna, Austria, 1090 | |
Principal Investigator: Johannes Drach, MD, Univ. Prof. | |
Dep. of Internal Medicine I, Oncology, SALK - Gemeinnützige Salzburger Landeskliniken | Recruiting |
Salzburg, Austria, 5020 | |
Principal Investigator: Richard Greil, MD, Univ. Prof. | |
Landeskrankenhaus Feldkirch | Recruiting |
Feldkirch, Austria | |
Principal Investigator: Alois Lang, MD, OA | |
Landeskrankenhaus Leoben | Recruiting |
Leoben, Austria | |
Principal Investigator: Felix Keil, MD, UNiv. Prof. | |
Klinischen Abteilung für Hämatologie, Medizinische Universitätsklinik Graz | Recruiting |
Graz, Austria, 8036 | |
Principal Investigator: Werner Linkesch, MD, Univ. Prof. | |
Klinikum Kreuzschwestern Wels GmbH | Recruiting |
Wels, Austria, 4600 | |
Principal Investigator: Thaler, MD Univ. Prof. | |
Czech Republic | |
FN Brno Interni Hematoonkolog. klinika | Recruiting |
Brno, Czech Republic, 62500 | |
Principal Investigator: Zdenek Adam, MD, Univ. Prof. |
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: | November 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00401804 |
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 Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Hemostatic Disorders |
Doxorubicin Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Kidney Failure, Acute Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell Kidney Failure |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Enzyme Inhibitors |
Antibiotics, Antineoplastic Hormones Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |