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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533217
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Spine Centre of Southern Denmark

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).

Condition or disease Intervention/treatment Phase
Vertebral Fracture Multiple Myeloma Procedure: Vertebroplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024


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.



Primary Outcome Measures :
  1. Improvement in back-specific disability [ Time Frame: 4 weeks post-initiation of treatment ]
    Oswestry Disability Index v2.1 (ODI): Each section is scored on a 0-5 scale, with 5 representing the highest disability.


Secondary Outcome Measures :
  1. Improvement in back-specific disability [ Time Frame: Up to 12 months post-initiation of treatment ]
    ODI

  2. Back and leg pain [ Time Frame: Up to 12 months post-initiation of treatment ]
    Visual Analogue Scale (VAS): 0-100 scale, with 100 representing the largest amount of pain

  3. Movement, personal care, usual activities, pain/discomfort, depression/anxiety [ Time Frame: Up to 12 months post-initiation of treatment ]

    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.

  4. Long-term stability of treated vertebra(e) [ Time Frame: 12 months post-initiation of treatment ]
    X-rays will be used to analyze long-term stability.

  5. General health services [ Time Frame: Up to 12 moths post-initiation of treatment ]
    General questionnaires on wether or not and to what extend the patients have been using general health services.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533217


Contacts
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Contact: Line Wickstroem, MD +4524411994 line.adsboll.wickstrom@rsyd.dk

Locations
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Denmark
Center for Spine Surgery and Research Recruiting
Middelfart, Region Of Southern Denmark, Denmark, 5500
Contact: Line Wickstrøm, MD    +4524411994    line.adsboll.wickstrom@rsyd.dk   
Sponsors and Collaborators
Spine Centre of Southern Denmark
  Study Documents (Full-Text)

Documents provided by Spine Centre of Southern Denmark:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spine Centre of Southern Denmark
ClinicalTrials.gov Identifier: NCT04533217    
Other Study ID Numbers: S-20200075
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Spinal Fractures
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone