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

Multiple Myeloma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533217
• Other study ID #: S-20200075
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: January 2024

Study information

• Verified date: September 2021
• Source: Spine Centre of Southern Denmark
• Contact: Line Wickstroem, MD
• Phone: +4524411994
• Email: line.adsboll.wickstrom[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Spinal Fractures
• Vertebral Fracture

Intervention

Procedure:
• Vertebroplasty
Injection of cement into vertebral lesion(s)

Locations

Country	Name	City	State
Denmark	Center for Spine Surgery and Research	Middelfart	Region Of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Spine Centre of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in back-specific disability	ODI	Up to 12 months post-initiation of treatment
Secondary	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
Secondary	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
Secondary	Long-term stability of treated vertebra(e)	X-rays will be used to analyze long-term stability.	12 months post-initiation of treatment
Secondary	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