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.

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).

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Vertebral Fracture
• Intervention / Treatment: Procedure: Vertebroplasty

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Line Wickstroem, MD; Phone Number: +4524411994; Email: line.adsboll.wickstrom@rsyd.dk

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Middelfart, Region Of Southern Denmark, Denmark, 5500
      • Recruiting
      • Center for Spine Surgery and Research
      • Contact: Line Wickstrøm, MD; Phone Number: +4524411994; Email: line.adsboll.wickstrom@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spine Centre of Southern Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Fractures, Bone; Wounds and Injuries; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Spinal Injuries; Back Injuries; Multiple Myeloma; Neoplasms, Plasma Cell; Spinal Fractures
• Other Study ID Numbers: S-20200075

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No