Bortezomib-Dexamethasone-Doxorubicin-Study
Overview[ - collapse ][ - ]
| Purpose | 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 | Multiple Myeloma Renal Insuficiency |
| Intervention | Drug: Dexamethasone, Bortezomib, Doxorubicin |
| Phase | Phase 2 |
| Sponsor | Austrian Forum Against Cancer |
| Responsible Party | Austrian Forum Against Cancer |
| ClinicalTrials.gov Identifier | NCT00401804 |
| First Received | November 20, 2006 |
| Last Updated | January 23, 2013 |
| Last verified | July 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 20, 2006 |
|---|---|
| Last Updated Date | January 23, 2013 |
| Start Date | February 2006 |
| Estimated Primary Completion Date | November 2009 |
| Current Primary Outcome Measures | OS |
| Current Secondary Outcome Measures | OR |
Descriptive Information[ + expand ][ + ]
| Brief Title | Bortezomib-Dexamethasone-Doxorubicin-Study |
|---|---|
| Official Title | Bortezomib-Doxorubicin-Dexamethasone as Treatment for Patients With Multiple Myeloma Presenting With Acute Renal Failure |
| 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Dexamethasone, Bortezomib, Doxorubicin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 72 |
| Estimated Completion Date | November 2009 |
| Estimated Primary Completion Date | November 2008 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Austria, Czech Republic |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00401804 |
|---|---|
| Other Study ID Numbers | Eudract Number: 2005-003001-85 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Austrian Forum Against Cancer |
| Study Sponsor | Austrian Forum Against Cancer |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Heinz Ludwig, MD, Univ.Prof. Austrian Forum agianst Cancer; Wilhelminenspital Vienna, 1st. Med. Department - center for Oncology and Hematology |
| Verification Date | July 2010 |
Locations[ + expand ][ + ]
| 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 |
| Universitätsklinik für Innere Medizin I | Vienna, Austria, 1090 |
| Wilhelminenspital Vienna, 1st Med. Department - center for Oncology and Hematology | Vienna, Austria, 1160 |
| Medical University of Vienna, Dep. of Internal Medicine I | Vienna, Austria, 1090 |
| Klinikum Kreuzschwestern Wels GmbH | Wels, Austria, 4600 |
| FN Brno Interni Hematoonkolog. klinika | Brno, Czech Republic, 62500 |