Vertebral column lesion in multiple myeloma- a prospective observation study

Recruiting

• Conditions: C90.0; Multiple myeloma

• Registration Number: DRKS00033326
• Lead Sponsor: niversitätsmedizin Charitè Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Multiple Myeloma patients with vertebral column lesions

Exclusion Criteria

Spinal metastases due to other tumor entities
Plasmocytoma
Age <18 years
Patient unable to consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint encompasses the development of Patient Reported Outcome Measures (PROMs), assessed every three months, over the entire observation period:<br>- Numeric rating scale for pain (NRS)<br>- Pain medication intake (WHO pain scale)<br>- Spinal Oncology Study group outcomes questionnaire 2.0 (SOSGOQ 2.0)<br>

Secondary Outcome Measures

Name	Time	Method
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