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Sponsored by: |
Austrian Forum Against Cancer |
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Information provided by: | Austrian Forum Against Cancer |
ClinicalTrials.gov Identifier: | NCT00902915 |
The purpose of this study is to determine efficacy of lenalidomide and dexamethasone in the treatment of patients with acute Myeloma (light chain)-induced renal failure.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma Light Chain Induced Renal Insufficiency |
Drug: lenalidomide plus dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 50 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | May 2014 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Patients with previously established MM and normal renal function (GFR ≥60ml/min and serum creatinine
Disease progression will be documented by one or more of the following criteria:
Laboratory test results within these ranges:
Females of childbearing potential (FCBP) must:
Male subjects must:
Exclusion Criteria:
Contact: Heinz P. Ludwig, Prof. Dr. | +43 1 49150 ext 2101 | heinz.ludwig@wienkav.at |
Austria | |
Austrian Forum Against Cancer; 1st Med. Dept., Center for Hematology and Oncology, Wilhelminenspital, Montleartstrasse 37 | Recruiting |
Vienna, Austria, 1160 | |
Principal Investigator: Heinz P. Ludwig, Prof. Dr. | |
Med. University Vienna, Clinic for Internal Medicine 1 (Hematology and Hemostaseology) | Not yet recruiting |
Vienna, Austria, 1090 | |
Contact: Heinz Gisllinger, Prof. Dr. +43 1 40400 ext 5464 heinz.gisslinger@meduniwien.ac.at | |
Med. University Vienna, Clinic for Internal Medicine I, Dept. for Oncology | Not yet recruiting |
Vienna, Austria, 1090 | |
Contact: Johannes Drach, Prof. Dr. +43 1 40400 ext 4466 johannes.drach@meduniwien.ac.at | |
Clinic Wels-Grieskirchen, 4th Internal Dept. | Recruiting |
4600, Austria, Wels | |
Contact: Josef Thaler, Prof. Dr. +43 7242 415 josef.thaler@klinikum-wegr.at | |
LKH Salzburg, 3rd Med. Dept. | Recruiting |
Salzburg, Austria, 5020 | |
Contact: Richard Greil, Prof. Dr. +43 662 4482 ext 2879 r.greil@salk.at | |
LKH Leoben, Dept. for Internal Medicine | Recruiting |
Leoben, Austria, 8700 | |
Contact: Felix Keil, Prof. Dr. +43 3842 401 ext 2821 felix.keil@lkh-leoben.at | |
LKH Feldkirch, Internal Dept. | Not yet recruiting |
Feldkirch, Austria, 6807 | |
Contact: Alois Lang, Dr. +43 5522 303 alois.lang@lkhf.at | |
Czech Republic | |
Faculty Hospital Brno and Faculty of Medicine MU | Not yet recruiting |
Brno, Czech Republic, 62500 | |
Contact: Zdenek Adam, Prof. Dr. | |
Charles University Prague | Not yet recruiting |
Prague, Czech Republic, 12821 | |
Contact: Ivan Spicka, Prof. Dr. | |
Slovakia | |
Hospital of St. Cyril and Method Bratislava | Not yet recruiting |
Brastislava, Slovakia, 85107 | |
Contact: Martin Mistrik, Ass. Prof. Dr. | |
Faculty Hospital with Policlinic Kosice | Not yet recruiting |
Kosice, Slovakia | |
Contact: Elena Tothova, Prof. Dr. |
Responsible Party: | Austian Forum Against Cancer ( Prof. Dr. Heinz Ludwig ) |
Study ID Numbers: | LD |
Study First Received: | May 14, 2009 |
Last Updated: | May 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00902915 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety; Czech Republic: State Institute for Drug Control; Slovakia: State Institute for Drug Control |
multiple myeloma renal insufficiency |
Anti-Inflammatory Agents Dexamethasone Renal Insufficiency Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Urologic Diseases Kidney Diseases |
Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Lenalidomide Glucocorticoids Multiple Myeloma Peripheral Nervous System Agents Lymphoproliferative Disorders Kidney Failure Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Renal Insufficiency Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Urologic Diseases Therapeutic Uses Cardiovascular Diseases |
Kidney Diseases Dexamethasone acetate Neoplasms by Histologic Type Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Gastrointestinal Agents Vascular Diseases Lenalidomide Glucocorticoids Pharmacologic Actions Multiple Myeloma Neoplasms Autonomic Agents |