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.
1 other identifier
interventional
90
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedDecember 3, 2024
November 1, 2024
4.3 years
June 9, 2020
November 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in back-specific disability
Oswestry Disability Index v2.1 (ODI): Each section is scored on a 0-5 scale, with 5 representing the highest disability.
4 weeks post-initiation of treatment
Secondary Outcomes (5)
Improvement in back-specific disability
Up to 12 months post-initiation of treatment
Back and leg pain
Up to 12 months post-initiation of treatment
Movement, personal care, usual activities, pain/discomfort, depression/anxiety
Up to 12 months post-initiation of treatment
Long-term stability of treated vertebra(e)
12 months post-initiation of treatment
General health services
Up to 12 moths post-initiation of treatment
Study Arms (2)
Vertebroplasty
ACTIVE COMPARATORPatients treated with vertebroplasty in addition to regular medical treatment.
Regular treatment
NO INTERVENTIONPatients treated with regular medical treatment.
Interventions
Eligibility Criteria
You may qualify if:
- known multiple myeloma
- verified lesion(s) between Th6-L5
- or less fractures
- relevant pain in 3 months or less
- vertebroplasty can be performed in one procedure
- VAS 5 or more
You may not qualify if:
- presence of neurologic deficit
- psychological or psychiatric disorder hat is expected to interfere with compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Spine Surgery and Research
Middelfart, Region Syddanmark, 5500, Denmark
Related Publications (1)
Wickstroem LA, Carreon L, Lund T, Abildgaard N, Lorenzen MD, Andersen MO. Vertebroplasty in patients with multiple myeloma with vertebral compression fractures: protocol for a single-blind randomised controlled trial. BMJ Open. 2021 Sep 6;11(9):e045854. doi: 10.1136/bmjopen-2020-045854.
PMID: 34489267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikkel Andersen, Professor
Centre of Spine Surgery and Research, Middelfart Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
August 31, 2020
Study Start
March 29, 2021
Primary Completion
July 31, 2025
Study Completion (Estimated)
July 31, 2026
Last Updated
December 3, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
All data of long-term value will be stored, e.g. for use in future studies on shorter-term or long-term follow-up or reuse. Metadata and anonymized data will be available for other researchers if possible due to confidentiality and GDPR.