Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.
Primary Purpose
Vertebral Fracture, Multiple Myeloma
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vertebroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Vertebral Fracture
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- presence of neurologic deficit
- psychological or psychiatric disorder hat is expected to interfere with compliance
Sites / Locations
- Center for Spine Surgery and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Vertebroplasty
Regular treatment
Arm Description
Patients treated with vertebroplasty in addition to regular medical treatment.
Patients treated with regular medical treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Improvement in back-specific disability
ODI
Back and leg pain
Visual Analogue Scale (VAS): 0-100 scale, with 100 representing the largest amount of pain
Movement, personal care, usual activities, pain/discomfort, depression/anxiety
Self-reported questionnaire on quality of life using:
- European Quality of Life - 5 Dimension (EQ-5D): 0-2 scale, with 2 representing the highest disability
EQ-5D contains questions on topics contributing to the overall feeling of quality of life:
movement
personal care
usual activities (ex. occupation, family activities)
pain/discomfort
depression/anxiety.
Long-term stability of treated vertebra(e)
X-rays will be used to analyze long-term stability.
General health services
General questionnaires on wether or not and to what extend the patients have been using general health services.
Full Information
NCT ID
NCT04533217
First Posted
June 9, 2020
Last Updated
September 21, 2021
Sponsor
Spine Centre of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04533217
Brief Title
Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spine Centre of Southern Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
Detailed Description
Patients identified by the attending consultant as eligible are invited to participate. Patients who express an interest in participating will be given written and oral information on the purpose, nature and implications of study-participation.
Possible candidates will be identified at the departments of Hematology where the patients are treated for their disease. All Danish departments of Hematology will be invited to participate.
The hematologist will inform the patient of the protocol and decide if they fulfil the inclusion and exclusion criteria. If the patient wishes to participate the hematologist will fill out screening forms regarding disease stage, lines of treatment, current disease status, bisphosphonate status, and pain relief treatment. The hematologist will refer the patient to their collaborating surgical department. The surgical department will decide if the patient has contraindications for surgery and inform the patient of the risk of the procedure.
If the patient decides to participate, he or she will fill out forms regarding ODI, VAS pain score, QoL.
Before randomization, the patients will be divided into two groups, stratifying between patients with known multiple myeloma with new diagnosed spine fracture and relevant pain ≤ 3 months prior to inclusion and patients with newly diagnosed multiple myeloma with new spine fracture.
Furthermore, to ensure balanced control and intervention groups the included patients at randomization will be stratified according to 1) panned PVP of 1 vs 2-4 levels, and 2) former vertebral fractures that are not planned treated with PVP.
The patients will be randomized to either PVP treatment or conservative treatment by drawing. It is therefore not possible for patients to choose between the treatments.
Patients randomized to vertebroplasty will be referred to a facility performing vertebroplasty. Patients randomized to non-vertebroplasty will receive the departments' usual care with the option to change treatment arm after 4 weeks.
The randomization will be performed by the diagnosing clinician, but orchestrated by one individual central to the clinics. The clinics will receive sealed envelopes containing the choice of randomization equally divided between PVP and conservative treatment. When all sealed envelopes have been used for randomization, the clinics will receive new envelopes.
It will not be possible to randomize more than one patient at a time. All patients will be contacted by a research nurse on a weekly basis the first 12 weeks after enrolment and after 3 and 12 months.
All patients randomized to vertebroplasty will undergo standard operative treatment involving a standard scheduled outpatient clinical control with the surgeon 12-weeks post-operative including long-standing radiographs of the spine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Fracture, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vertebroplasty
Arm Type
Active Comparator
Arm Description
Patients treated with vertebroplasty in addition to regular medical treatment.
Arm Title
Regular treatment
Arm Type
No Intervention
Arm Description
Patients treated with regular medical treatment.
Intervention Type
Procedure
Intervention Name(s)
Vertebroplasty
Intervention Description
Injection of cement into vertebral lesion(s)
Primary Outcome Measure Information:
Title
Improvement in back-specific disability
Description
Oswestry Disability Index v2.1 (ODI): Each section is scored on a 0-5 scale, with 5 representing the highest disability.
Time Frame
4 weeks post-initiation of treatment
Secondary Outcome Measure Information:
Title
Improvement in back-specific disability
Description
ODI
Time Frame
Up to 12 months post-initiation of treatment
Title
Back and leg pain
Description
Visual Analogue Scale (VAS): 0-100 scale, with 100 representing the largest amount of pain
Time Frame
Up to 12 months post-initiation of treatment
Title
Movement, personal care, usual activities, pain/discomfort, depression/anxiety
Description
Self-reported questionnaire on quality of life using:
- European Quality of Life - 5 Dimension (EQ-5D): 0-2 scale, with 2 representing the highest disability
EQ-5D contains questions on topics contributing to the overall feeling of quality of life:
movement
personal care
usual activities (ex. occupation, family activities)
pain/discomfort
depression/anxiety.
Time Frame
Up to 12 months post-initiation of treatment
Title
Long-term stability of treated vertebra(e)
Description
X-rays will be used to analyze long-term stability.
Time Frame
12 months post-initiation of treatment
Title
General health services
Description
General questionnaires on wether or not and to what extend the patients have been using general health services.
Time Frame
Up to 12 moths post-initiation of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
presence of neurologic deficit
psychological or psychiatric disorder hat is expected to interfere with compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Line Wickstroem, MD
Phone
+4524411994
Email
line.adsboll.wickstrom@rsyd.dk
Facility Information:
Facility Name
Center for Spine Surgery and Research
City
Middelfart
State/Province
Region Of Southern Denmark
ZIP/Postal Code
5500
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Line Wickstrøm, MD
Phone
+4524411994
Email
line.adsboll.wickstrom@rsyd.dk
12. IPD Sharing Statement
Citations:
PubMed Identifier
34489267
Citation
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.
Results Reference
derived
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Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.
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