To Compare Conservative Management Vs. Balloon Kyphoplasty in the Treatment of VCFs in Patients With Multiple Myeloma (MELODY)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Vertebral Compression Fracture, Balloon Kyphoplasty, Conservative treatment, Sham procedure, VCFs, Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤80 years old
- Diagnosis of Multiple Myeloma
- Confirmed acute (MRI, a detectable low signal T1 ± oedema) painful vertebral compression fracture(s) VAS score is ≥6
- The patient is able to read and understand the Patient Information Sheet and study procedures
- The patient is able and willing to give written informed consent
Exclusion Criteria:
- Contraindications to anaesthesia
- Cord Compression or large epidural mass necessitating conservative management before balloon kyphoplasty
- Pain unrelated to vertebral collapse
- Infection at the site
- Presence of overt instability as judged by the principle investigator
- Known pregnancy at time of screening
- Severe Cardiopulmonary insufficiency
- Osteoblastic lesions
- Any co-morbidity, (e.g., diabetes, heart condition, obesity, psychiatric illness) which, in the opinion of the investigator, is of a severe enough nature to; interfere with the patient's ability to complete the study assessments; or present an unacceptable risk to the patient's safety to undergo study treatment
Sites / Locations
- Royal National Orthopaedic NHS Trust, Brockley Hill
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Active Comparator
Arm 1 - Sham Procedure
Arm 2 - Balloon Kyphoplasty
Sham Procedure & Conservative Treatment Subjects will be blinded and randomised to Arm 1 and will undergo a general anaesthetic and undergo a sham procedure. They will also be treated under conservative management alone. Below is a list of the conservative management they will be managed by their Doctor: Bisphosphonates Pain relief Systemic chemotherapy for Myeloma disease Bed rest Radiotherapy Physiotherapy This is a non interventional as conservative treatment (standard of care for multiple myeloma patients) is used.
Balloon Kyphoplasty & Conservative Treatment - Interventional Arm Subjects will be blinded and randomised to Arm 2 (balloon kyphoplasty) and will undergo a general anaesthetic and undergo a balloon kyphoplasty surgical procedure. They will also be treated with conservative management. Below is a list of the conservative management they will be managed by their Doctor: Bisphosphonates Pain relief Systemic chemotherapy for Myeloma disease Bed rest Radiotherapy Physiotherapy This is a interventional arm (balloon kyphoplasty procedure) and the patient will receive conservative treatment (standard of multiple myeloma patients) is used.