Vertebroplasty for treating vertebral fractures in multiple myeloma patients
Official title: Palliative Treatment of Patients With Multiple Myeloma and Painful Vertebral Lesions. A Cross-sectoral Randomized Controlled Trial of Vertebroplasty in Addition to Regular Medical Treatment.
Run by Spine Centre of Southern Denmark · NCT04533217 · Data updated 2026-11-12
This study tests if adding a procedure called vertebroplasty to standard treatment can help people with multiple myeloma and vertebral fractures feel less pain and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Spine Centre of Southern Denmark Academic / other |
| Locations | 1 site (Middelfart, Region Syddanmark) |
| Status | Recruiting |
| Started | March 29, 2021 |
| Main results expected | July 31, 2025 |
| Study ends | July 31, 2026 |
| Registry record updated | December 3, 2024 |
| Trial ID | NCT04533217 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with known multiple myeloma, verified vertebral lesions, and relevant pain within the last three months.
✕Probably not a fit
Patients with neurological deficits or psychological disorders that may affect compliance will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of vertebroplasty in addition to standard medical treatment for patients with multiple myeloma who have newly diagnosed vertebral lesions. Participants will be randomly assigned to receive either regular treatment or vertebroplasty, allowing researchers to compare outcomes between the two groups. Eligible patients will be identified at hematology departments across Denmark, and their treatment will be monitored for pain relief and quality of life. The study aims to clarify the role of surgical intervention in managing vertebral fractures associated with multiple myeloma.
Why it matters
Potential benefit: If successful, this study could improve pain management and quality of life for patients with multiple myeloma and vertebral fractures.
How similar studies have gone: Other studies have explored vertebroplasty for vertebral fractures, showing promising results, but this specific approach in multiple myeloma is less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * known multiple myeloma * verified lesion(s) between Th6-L5 * 4 or less fractures * relevant pain in 3 months or less * vertebroplasty can be performed in one procedure * VAS 5 or more Exclusion Criteria: * presence of neurologic deficit * psychological or psychiatric disorder hat is expected to interfere with compliance
Where it's running
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Center for Spine Surgery and Research
Middelfart, Region Syddanmark, Denmark Recruiting
Study contacts
- Principal investigator: Mikkel Andersen, Professor — Centre of Spine Surgery and Research, Middelfart Hospital
- Study coordinator: Line Wickstroem, MD
- Email: line.adsboll.wickstrom@rsyd.dk
- Phone: +4524411994
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.