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Bortezomib-Dexamethasone-Doxorubicin-Study

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ClinicalTrials.gov Identifier: NCT00401804
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Austrian Forum Against Cancer

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Renal Insuficiency Drug: Dexamethasone, Bortezomib, Doxorubicin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bortezomib-Doxorubicin-Dexamethasone as Treatment for Patients With Multiple Myeloma Presenting With Acute Renal Failure
Study Start Date : February 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2009





Primary Outcome Measures :
  1. OS

Secondary Outcome Measures :
  1. OR


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401804


Locations
Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Klinischen Abteilung für Hämatologie, Medizinische Universitätsklinik Graz
Graz, Austria, 8036
Landeskrankenhaus Leoben
Leoben, Austria
Dep. of Internal Medicine I, Oncology, SALK - Gemeinnützige Salzburger Landeskliniken
Salzburg, Austria, 5020
Medical University of Vienna, Dep. of Internal Medicine I
Vienna, Austria, 1090
Universitätsklinik für Innere Medizin I
Vienna, Austria, 1090
Wilhelminenspital Vienna, 1st Med. Department - center for Oncology and Hematology
Vienna, Austria, 1160
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Austrian Forum Against Cancer
ClinicalTrials.gov Identifier: NCT00401804     History of Changes
Other Study ID Numbers: Eudract Number: 2005-003001-85
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: July 2010

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Liposomal doxorubicin
Doxorubicin
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal