Bortezomib-Dexamethasone-Doxorubicin-Study

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401804
• Other study ID #: Eudract Number: 2005-003001-85
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2006
• Last updated: January 23, 2013
• Start date: February 2006
• Est. completion date: November 2009

Study information

• Verified date: July 2010
• Source: Austrian Forum Against Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionCzech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlHungary: National Institute of PharmacyCroatia: Ministry of Health and Social Care
• Study type: Interventional

Clinical 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 evaluate the activity of Bortezomib- Doxorubicin -Dexamethasone on progression free survival · to evaluate the activity of Bortezomib- Doxorubicin -Dexamethasone on overall survival

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Renal Insuficiency

Intervention

Drug:
• Dexamethasone, Bortezomib, Doxorubicin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Forum Against Cancer

Countries where clinical trial is conducted

Austria,  Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS
Secondary	OR