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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Vertebral Fracture, Multiple Myeloma

Intervention / Treatment
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* Procedure: Vertebroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vertebroplasty<br>Patients treated with vertebroplasty in addition to regular medical treatment. | Procedure: Vertebroplasty<br>* Injection of cement into vertebral lesion(s)<br>|
| No Intervention: Regular treatment<br>Patients treated with regular medical treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in back-specific disability | ODI | Up to 12 months post-initiation of treatment | 
| Back and leg pain | Visual Analogue Scale (VAS): 0-100 scale, with 100 representing the largest amount of pain | Up to 12 months post-initiation of treatment | 
| 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. | Up to 12 months post-initiation of treatment | 
| Long-term stability of treated vertebra(e) | X-rays will be used to analyze long-term stability. | 12 months post-initiation of treatment | 
| General health services | General questionnaires on wether or not and to what extend the patients have been using general health services. | Up to 12 moths post-initiation of treatment |