Bortezomib-Dexamethasone-Doxorubicin-Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00401804
• Date of registration: 20/11/2006
• Prospective Registration: No
• Primary sponsor: Austrian Forum Against Cancer
• Public title: Bortezomib-Dexamethasone-Doxorubicin-Study
• Scientific title: Bortezomib-Doxorubicin-Dexamethasone as Treatment for Patients With Multiple Myeloma Presenting With Acute Renal Failure
• Date of first enrolment: February 2006
• Target sample size: 72
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00401804
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Austria, Czech Republic

Contacts

• Name: Heinz Ludwig, MD, Univ.Prof.
• Affiliation: Austrian Forum agianst Cancer; Wilhelminenspital Vienna, 1st. Med. Department - center for Oncology and Hematology

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Insuficiency

Multiple Myeloma

Intervention(s)

Drug: Dexamethasone, Bortezomib, Doxorubicin

Primary Outcome(s)

OS

Secondary Outcome(s)

OR

Secondary ID(s)

Eudract Number: 2005-003001-85

Source(s) of Monetary Support

Please refer to primary and secondary sponsors