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Multiple MyelomaPhase 2NCT00401804

Bortezomib-Dexamethasone-Doxorubicin-Study

A Phase 2 study testing Dexamethasone, Bortezomib, Doxorubicin in people with Multiple Myeloma and Renal Insuficiency, run by Austrian Forum Against Cancer at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Renal Insuficiency
What is being tested?
Dexamethasone, Bortezomib, Doxorubicin
How many people
72 participants
Where
9 sitesin 2 countries
Study dates
Feb 2006to Nov 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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·
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  • 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

Who cannot join

  • 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 ·
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  • 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

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Austria8 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch

  • Klinischen Abteilung für Hämatologie, Medizinische Universitätsklinik Graz

    Graz, 8036

  • Landeskrankenhaus Leoben

    Leoben

  • Dep. of Internal Medicine I, Oncology, SALK - Gemeinnützige Salzburger Landeskliniken

    Salzburg, 5020

  • Medical University of Vienna, Dep. of Internal Medicine I

    Vienna, 1090

  • Universitätsklinik für Innere Medizin I

    Vienna, 1090

  • Wilhelminenspital Vienna, 1st Med. Department - center for Oncology and Hematology

    Vienna, 1160

  • Klinikum Kreuzschwestern Wels GmbH

    Wels, 4600

Other trials in Austria

Czechia1 site

  • FN Brno Interni Hematoonkolog. klinika

    Brno, 62500

Other trials in Czechia

About this study

Official title: 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

Being tested
Dexamethasone, Bortezomib, Doxorubicin
Keywords
Multiple Myeloma, renal impairment, Velcade
Medical subject headings
Multiple Myeloma, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone, Bortezomib, DoxorubicinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

Secondary outcomes (1)

  1. OR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionNov 2008
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401804
Sponsor's protocol ID
Eudract Number: 2005-003001-85
Status last verified
Jul 2010
First submitted
20 Nov 2006
Last updated
24 Jan 2013
Results posted
No

Publications

  • Ludwig H, Adam Z, Hajek R, Greil R, Tothova E, Keil F, Autzinger EM, Thaler J, Gisslinger H, Lang A, Egyed M, Womastek I, Zojer N. Light chain-induced acute renal failure can be reversed by bortezomib-doxorubicin-dexamethasone in multiple myeloma: results of a phase II study. J Clin Oncol. 2010 Oct 20;28(30):4635-41. doi: 10.1200/JCO.2010.28.1238. Epub 2010 Sep 7.

    PubMed 20823423

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Bortezomib, Doxorubicin in people with Multiple Myeloma and Renal Insuficiency, run by Austrian Forum Against Cancer at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Austria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401804, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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