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Bortezomib-Dexamethasone-Doxorubicin-Study
This study is currently recruiting participants.
Verified by Austrian Forum Against Cancer, November 2006
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

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Kidney Failure Multiple Myeloma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Bortezomib
U.S. FDA Resources
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

Further study details as provided by Austrian Forum Against Cancer:

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: June 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

Contacts
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

Locations
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.            
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

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009