C90.0
Conditions
Interventions
Group 1: Conservative management
Group 2: Surgical management
Sponsors
Universitätsmedizin Charitè Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Multiple Myeloma patients with vertebral column lesions
Exclusion criteria
Exclusion criteria: Spinal metastases due to other tumor entities Plasmocytoma Age <18 years Patient unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint encompasses the development of Patient Reported Outcome Measures (PROMs), assessed every three months, over the entire observation period: - Numeric rating scale for pain (NRS) - Pain medication intake (WHO pain scale) - Spinal Oncology Study group outcomes questionnaire 2.0 (SOSGOQ 2.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications of conservative/surgical management are assessed every 3 months as part of routine clinical tumor surveillance. This includes the occurrence of new/increasing pain, neurological deficits, pathological fractures. In the case of surgical treatment, occurrences such as wound healing problems, surgical site infections, hardware failure, revision surgeries, etc., are documented | — |
Countries
Austria, Germany, Italy, Switzerland, United Kingdom, United States
Contacts
Public ContactEmily von Bronewski
Universitätsmedizin-Charité Berlin
Outcome results
None listed