Vertebroplasty for treating vertebral fractures in multiple myeloma patients
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spine Centre of Southern Denmark Academic / other |
| Locations | 1 site (Middelfart, Region Syddanmark) |
| Trial ID | NCT04533217 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with known multiple myeloma, verified vertebral lesions, and relevant pain within the last three months.
Not a fit: Patients with neurological deficits or psychological disorders that may affect compliance will not benefit from this study.
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 performed: Other studies have explored vertebroplasty for vertebral fractures, showing promising results, but this specific approach in multiple myeloma is less common.
Eligibility criteria
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 this trial is running
Middelfart, Region Syddanmark
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.