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Bortezomib-Dexamethasone-Doxorubicin-Study
This study is ongoing, but not recruiting participants.
First Received: November 20, 2006   Last Updated: May 14, 2009   History of Changes
Sponsored by: Austrian Forum Against Cancer
Information provided by: Austrian Forum Against Cancer
ClinicalTrials.gov Identifier: NCT00401804
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Austrian Forum Against Cancer:

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: August 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma ·
  • Acute multiple myeloma related renal failure (Diagnosis established by clinical and laboratory findings including renal biopsy - if indicated)a) Newly diagnosed patients:Decrease of GFR to < 50ml/minb) Previously treated patients with GFR of ≥ 60ml/min within last 4 weeks: decrease in GFR > 25% and to < 60ml / min,concomitantly with either increase in paraproteins (>25%) and/or decrease in hemoglobin ≥ 2 g/dl (within 4 weeks) and/or increase in bone marrow plasma infiltration and/or increase in number of bone lesions and/or hypercalcaemia (Ca > 11.5 mg/dl or 2.8 mmol/l) as signs of disease progression·
  • Age > 20 years·
  • ECOG performance status of ≤ 3.·
  • Platelet count > 50.000/µl·
  • WBC > 2000/µl·
  • Total bilirubin < 1.5 x upper limit of normal,
  • AST, ALT < 2.5 x upper limit of normal·
  • International Normalized Ratio (INR) < 1.5; APTT < 1.5 x upper limit of normal·
  • Fertile women and men of childbearing potential (<2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)· Negative serum or urine β-HCG pregnancy test at screening for subjects of child-bearing potential·
  • Patient's written informed consent

Exclusion Criteria:

  • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.·
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.·
  • Evidence of CNS involvement or spinal cord compression.·
  • Neuropathy Grade ≥ 2·
  • A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drug.·
  • NYHA Status > 2, i.e. clinically significant cardiac disease, (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias, and arterial hypertension not well controlled with medication) or myocardial infarction within the last 6 months ·
  • Evidence of bleeding diathesis or coagulopathy·
  • Serious, non-healing wound or ulcer·
  • Evidence of any severe active acute or chronic infection.·
  • Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications·
  • Patient is known to be HIV-positive, Hbs-antigen positive or HCV-RNA-positive·
  • Pregnant women or nursing mothers·
  • Have received bortezomib within 4 weeks before enrollment·
  • Half body irradiation < 28 days before enrollment·
  • Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401804

Locations
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
Sponsors and Collaborators
Austrian Forum Against Cancer
Investigators
Principal Investigator: Heinz Ludwig, MD, Univ.Prof. Austrian Forum agianst Cancer; Wilhelminenspital Vienna, 1st. Med. Department - center for Oncology and Hematology
  More Information

No publications provided

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

Keywords provided by Austrian Forum Against Cancer:
Multiple Myeloma
renal impairment
Velcade

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 03, 2009