RecruitingNot ApplicableNCT04533217

Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.

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.


Sponsor

Spine Centre of Southern Denmark

Enrollment

90 participants

Start Date

Mar 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether adding a bone-strengthening procedure called vertebroplasty — where medical cement is injected into a fractured vertebra — improves pain relief in multiple myeloma patients who have spinal fractures. **You may be eligible if...** - You have been diagnosed with multiple myeloma (a blood cancer that weakens bones) - You have a confirmed fracture or lesion in the spine between the mid-back and lower back (vertebrae Th6–L5) - You have 4 or fewer spinal fractures - Your pain has been present for 3 months or less - Your pain is rated 5 or higher on a 0–10 pain scale - All fractures can be treated in one procedure **You may NOT be eligible if...** - You have neurological problems (such as weakness or numbness in the limbs) related to the fracture - You have a psychological or psychiatric condition that would interfere with your ability to follow the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVertebroplasty

Injection of cement into vertebral lesion(s)


Locations(1)

Center for Spine Surgery and Research

Middelfart, Region Syddanmark, Denmark

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NCT04533217


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