Clinical trial · Interventional
To Compare Conservative Management Vs. Balloon Kyphoplasty in the Treatment of VCFs in Patients With Multiple Myeloma
Multiple Myeloma Spinal Disease Study; A Multi-centre, Prospective, Single Blinded, Randomized, Controlled Study to Compare Conservative Management Alone Vs. Balloon Kyphoplasty With the Treatment of VCFs in Patients With Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties with recruitment due to change in referral rates.
Summary
Brief summary (as posted)
The purpose of this study is to determine whether surgical treatment, balloon kyphoplasty is more effective compared to conservative treatment alone (sham procedure) when assessing clinical, translational, radiological \& patient outcomes in patients with multiple myeloma. Subjects will be recruited to the study if they have VAS score ≥ 6 and has given informed consent to participate in the Melody Study will be randomised to Arm 1 Sham Procedure and Conservative treatment or Arm 2 Balloon Kyphoplasty and Conservative treatment. Subjects recruited to Arm 1 (Sham Procedure and Conservative treatment) can cross over into Arm 2 (Balloon Kyphoplasty and Conservative Treatment) if they have a VAS score ≥ 6 between 8-12 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm 2 Balloon Kyphoplasty | Device | — | UNRESOLVED |
| Conservative Management | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Arm 1 - Sham Procedure
- description
- 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: 1. Bisphosphonates 2. Pain relief 3. Systemic chemotherapy for Myeloma disease 4. Bed rest 5. Radiotherapy 6. Physiotherapy This is a non interventional as conservative treatment (standard of care for multiple myeloma patients) is used.
- interventionNames
- Procedure: Conservative Management
- type
- ACTIVE_COMPARATOR
- label
- Arm 2 - Balloon Kyphoplasty
- description
- 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: 1. Bisphosphonates 2. Pain relief 3. Systemic chemotherapy for Myeloma disease 4. Bed rest 5. Radiotherapy 6. Physiotherapy This is a interventional arm (balloon kyphoplasty procedure) and the patient will receive conservative treatment (standard of multiple myeloma patients) is used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available