The occurrence of renal failure is an emergency situation in patients with multiple myeloma. A fast active relatively, non-toxic protocol seems presently the best option for attempts to reverse renal insufficiency. Therefore we have designed a small Phase 2 trial with a Bortezomib containing regimen, which intends to revert renal failure in a greater proportion of patients compared to conventional regimens.
Conditions
Interventions
Trade Name: VELCADE 3.5 mg powder for solution for injection
Product Name: Velcade
Product Code: PS-341
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Bortezomib
Concentration unit: m
Sponsors
Austrian Forum against Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters - Acute renal failure in patients with multiple myeloma - by newly diagnosed patients: glomerular filtration rate ( 25% compared to pre renal failure level (within 4 weeks), or to 25%) and/or decrease in hemoglobin = 2 g/dl (within 4 weeks) and/or increase in bone marrow plasma infiltration as signs of disease progression; - Age > 20 years - ECOG performance status of = 3 (Appendix IV) - Platelet count > 50.000/µl - WBC > 2000/µl - Neutrophils ³ 1000/µl - Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 3 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 (see also Appendix VIII). - 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 the planned start of treatment - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to evaluate the activity of Bortezomib – Doxorubicin - Dexamethasone in subjects with acute renal failure as measured by reversal of acute renal failure ;Secondary Objective: The secondary objectives of this study are to evaluate: - tumor response (complete and partial response), - the safety of Bortezomib – Doxorubicin – Dexamethasone in this patient population, - the activity Bortezomib – Doxorubicin – Dexamethasone on progression free survival, - the activity Bortezomib – Doxorubicin – Dexamethasone on overall survival. ;Primary end point(s): Reversal of renal failure (increase of the GFR level > 50 % to pre-treatment GFR level or equal to the last “normal” pre-study GFR level). | — |
Countries
Austria, Czech Republic, Hungary, Slovakia
Outcome results
None listed