Bortezomib-Dexamethasone-Doxorubicin-Study

January 23, 2013 updated by: Austrian Forum Against Cancer

Bortezomib-Doxorubicin-Dexamethasone as Treatment for Patients With Multiple Myeloma Presenting With Acute Renal Failure

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria
        • Landeskrankenhaus Feldkirch
      • Graz, Austria, 8036
        • Klinischen Abteilung für Hämatologie, Medizinische Universitätsklinik Graz
      • Leoben, Austria
        • Landeskrankenhaus Leoben
      • Salzburg, Austria, 5020
        • Dep. of Internal Medicine I, Oncology, SALK - Gemeinnützige Salzburger Landeskliniken
      • Vienna, Austria, 1090
        • Medical University of Vienna, Dep. of Internal Medicine I
      • Vienna, Austria, 1090
        • Universitätsklinik für Innere Medizin I
      • Vienna, Austria, 1160
        • Wilhelminenspital Vienna, 1st Med. Department - center for Oncology and Hematology
      • Wels, Austria, 4600
        • Klinikum Kreuzschwestern Wels GmbH
  • Czech Republic
      • Brno, Czech Republic, 62500
        • FN Brno Interni Hematoonkolog. klinika

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
OS

Secondary Outcome Measures

Outcome Measure
OR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 20, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eudract Number: 2005-003001-85

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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