Status:
COMPLETED
Effect of Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Disease in Patients With Multiple Myeloma Relapsed After 1-3 Prior Lines of Therapy
Lead Sponsor:
University of Athens
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the effect of bortezomib in combination with dexamethasone and zoledronic acid on bone mineral density (BMD) and skeletal related events (SREs) in Patients with Mu...
Detailed Description
Multiple Myeloma represents a malignant proliferation of plasma cells derived from a single clone. The most common symptom in myeloma, affecting more than 70% of patients at diagnosis, is bone pain. T...
Eligibility Criteria
Inclusion
- Patients with Multiple Myeloma who Have Relapsed after 1-3 Prior Lines of Therapy
- Women \> 50 years old
- Κarnofsky performance status ≥ 60 (patients with lower performance status due to myeloma bone disease can also be included)
- Measurable disease
- Platelet count \>50x10(9)/L
- Neutrophil count \>0.75x10(9)/L
- Hemoglobin ≥7.0 g/dL (the use of recombinant human erythropoietin or red blood Hell transfusions to maintain hemoglobin levels above 7.0 g/dL is not an exclusion criterion)
- Serum ALT and AST ≤ 3-fold of upper normal limit
- Serum bilirubin ≤ 2-fold of upper normal limit
- Serum Calcium ≤ 10.5 mg/dL
- Expected survival ≥ 2 months
- Signed informed consent
Exclusion
- Presence of another cancer
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Grade 2-4 peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
- Pregnant women \> 50 years old or breast-feeding
- Woman \> 50 years old capable of becoming pregnant \[anyone who has not undergone a hysterectomy, has not had both ovaries removed or has not been post-menopausal for more than 24 months in a row not using adequate contraception
- Known or suspected hypersensitivity or intolerance to bortezomib, boron, mannitol, zoledronic acid, dexamethasone, or heparin (if an indwelling catheter is used)
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months prior to first dose of study drug)
- Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 4, NYHA Classification of Cardiac Disease), uncontrolled angina, pericardial disease, or cardiac amyloidosis
- Acute diffuse infiltrative pulmonary disease
- History of hypotension or patient has decreased blood pressure (sitting systolic blood pressure \[SBP\] 100 mmHg and/or sitting diastolic blood pressure \[DBP\] 60 mmHg)
- Patient has received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks prior to enrolment
- Patient has received any drugs or agents that inhibit (e.g., cimetidine, erythromycin, fluoxetine, ketoconazole, paroxetine) or induce (e.g., carbamazepine, glucocorticoids, phenobarbital, rifampin) CYP2C19 or CYP3A4 within 14 days before the first dose of VELCADE (proton pump inhibitors are allowed)
- Need for therapy with concomitant CYP 3A4 inhibitors (e.g., itraconazole, fluconazole, clarithromycin, erythromycin, norfloxacin, fluvoxamine, cimetidine, indinavir, ritonavir) or inducers (e.g., efavirenz, barbiturates, phenytoin, rifampin, glitazones). Proton pump inhibitors are allowed.
- Patient has received an experimental drug or has used an experimental medical device within 4 weeks prior to the planned start of treatment. Concurrent participation in non-treatment studies is allowed, provided it will not interfere with participation in this study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00972959
Start Date
July 1 2009
End Date
May 1 2013
Last Update
August 5 2014
Active Locations (3)
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1
Department of Clinical Therapeutics, University of Athens School of Medicine, "Alexandra" General Hospital
Athens, Greece, 115 28
2
Department of Hematology & Medical Research, 251 General Air Force Hospital
Athens, Greece, 11525
3
Department of Hematology, "Theagenion" Cancer Center
Thessaloniki, Greece, 540 07