Clinical trial NCT04533217: 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
Overall status: RECRUITING
Phase: NA
Conditions: Vertebral Fracture
Multiple Myeloma
Lead sponsor: Spine Centre of Southern Denmark
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in back-specific disability
timeFrame: 4 weeks post-initiation of treatment
Secondary outcomes:
measure: Improvement in back-specific disability
timeFrame: Up to 12 months post-initiation of treatment
measure: Back and leg pain
timeFrame: Up to 12 months post-initiation of treatment
measure: Movement, personal care, usual activities, pain/discomfort, depression/anxiety
timeFrame: Up to 12 months post-initiation of treatment
measure: Long-term stability of treated vertebra(e)
timeFrame: 12 months post-initiation of treatment
measure: General health services
timeFrame: Up to 12 moths post-initiation of treatment
Other outcomes:
Locations:
city: Middelfart
country: Denmark
facility: Center for Spine Surgery and Research
state: Region Of Southern Denmark
Study officials:
affiliation: Centre of Spine Surgery and Research, Middelfart Hospital
name: Mikkel Andersen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.