Bortezomib-Dexamethasone-Doxorubicin-Study

NCT00401804 | Completed Phase 2

• 1 other identifier: Eudract Number: 2005-003001-85
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 9

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

Conditions

Multiple Myeloma; Renal Insuficiency

Keywords

Multiple Myeloma; renal impairment; Velcade

Outcome Measures

Primary Outcomes (1)

• OS

Secondary Outcomes (1)

• OR

Interventions

Dexamethasone, Bortezomib, Doxorubicin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Austrian Forum Against Cancer: lead

Study Sites (9)

Landeskrankenhaus Feldkirch

Feldkirch, Austria

Location

Klinischen Abteilung für Hämatologie, Medizinische Universitätsklinik Graz

Graz, 8036, Austria

Location

Landeskrankenhaus Leoben

Leoben, Austria

Location

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

Salzburg, 5020, Austria

Location

Medical University of Vienna, Dep. of Internal Medicine I

Vienna, 1090, Austria

Location

Universitätsklinik für Innere Medizin I

Vienna, 1090, Austria

Location

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

Vienna, 1160, Austria

Location

Klinikum Kreuzschwestern Wels GmbH

Wels, 4600, Austria

Location

FN Brno Interni Hematoonkolog. klinika

Brno, 62500, Czechia

Location

Related Publications (1)

• 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.

  PMID: 20823423 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Renal Insufficiency

Interventions

Dexamethasone; Bortezomib; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Heinz Ludwig, MD, Univ.Prof.

  Austrian Forum agianst Cancer; Wilhelminenspital Vienna, 1st. Med. Department - center for Oncology and Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: February 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2009
• Last Updated: January 24, 2013

Record last verified: 2010-07

Locations

AU (8); CZ (1)