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.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Center for Spine Surgery and Research
RECRUITING
Middelfart
Contact Information
Primary
Line Wickstroem, MD
line.adsboll.wickstrom@rsyd.dk
+4524411994
Backup
Mikkel Andersen, Professor
mikkel.andersen2@rsyd.dk
+4540344069
Time Frame
Start Date: 2021-03-29
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 90
Treatments
Active_comparator: Vertebroplasty
Patients treated with vertebroplasty in addition to regular medical treatment.
No_intervention: Regular treatment
Patients treated with regular medical treatment.
Related Therapeutic Areas
Sponsors
Leads: Spine Centre of Southern Denmark