Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04533217

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

Led by Spine Centre of Southern Denmark · Updated on 2024-12-03

90

Participants Needed

1

Research Sites

278 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Known multiple myeloma
  • Verified vertebral lesion(s) between thoracic vertebra 6 (Th6) and lumbar vertebra 5 (L5)
  • Four or fewer vertebral fractures
  • Relevant pain lasting 3 months or less
  • Vertebroplasty can be performed in one procedure
  • Pain score (VAS) of 5 or more
Not Eligible

You will not qualify if you...

  • Presence of neurological deficit
  • Psychological or psychiatric disorder expected to interfere with compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Center for Spine Surgery and Research

Middelfart, Region Syddanmark, Denmark, 5500

Actively Recruiting

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Research Team

L

Line Wickstroem, MD

CONTACT

M

Mikkel Andersen, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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