Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multip… (NCT01410929) | Clinical Trial Compass
WithdrawnPhase 4
Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma
0Started 2011-05
Plain-language summary
The objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.
Who can participate
Age range
21 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
. Diagnosis of multiple myeloma and evidence of myelomatous lesions in the spine, including plasmacytomas, lytic lesions and fractures.
. One to 6 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T3-L5, with bone marrow edema imaged by magnetic resonance imaging (MRI) (Subjects with 4-6 fractures treatment will be divided into two sessions 1- 7 days apart)
. History of fracture related pain less than ≤ 3 months old
. Pain VAS score ≥4 on a scale of 0 to 10. When the subject is newly diagnosed with multiple myeloma, the pain assessment must not be done until after completion of at least one pulse of steroid therapy or one week after the initiation of active multiple myeloma chemotherapy. Pain represents worst pain without use of narcotic medications.
. Roland Morris Disability Questionnaire score ≥ 10 on 0 to 24 scale
. Subjects is ≥ 21 years old.
. No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment
. No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1 month following enrollment
Exclusion criteria
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.
What they're measuring
1
Improvement in functional status, as measured by the Oswestry Disability Index (ODI)
. Subjects with primary tumors of the bone (e.g., osteosarcoma) or osteoblastic metastases at site of the index VCF. Subjects with these tumors in anatomic sites other than the index VCF are eligible.
. Subject is concurrent Phase I investigational anti-cancer treatment
. Subject has significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function
. Subject has VCF morphology deemed unsuitable for RF Kyphoplasty (e.g. vertebral planna)
. Additional non-kyphoplasty surgical treatment is required for the index fracture
. Subjects requiring the use of high-dose steroid (≥ 100 mg prednisone or 20 mg dexamethasone per day), intravenous (IV) pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Subjects who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
. Subjects with a platelet count of \< 20,000
. Subject has spinal cord compression or significant canal compromise requiring decompression