Effect of Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Disease in Patients Wit… (NCT00972959) | Clinical Trial Compass
CompletedPhase 2
Effect of Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Disease in Patients With Multiple Myeloma Relapsed After 1-3 Prior Lines of Therapy
Greece17 participantsStarted 2009-07
Plain-language 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 Multiple Myeloma who Have Relapsed after 1-3 Prior Lines of Therapy
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …