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 range
18 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.