MELODY
Research type
Research Study
Full title
Multiple Myeloma Spinal Disease Study; A single-centre, prospective, single blinded, randomised, controlled study to compare balloon kyphoplasty with conservative management alone in the treatment of Vertebral Compression Fractures (VCFs) in patients with Multiple Myeloma.
IRAS ID
169682
Contact name
Charalampia Kyriakou
Contact email
Sponsor organisation
Royal National Orthopaedic Hospital NHS Trust
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
A prospective, single blinded, randomised, controlled study to compare conservative management alone, sham procedure (Arm 1) with surgical procedure, balloon kyphoplasty and conservative treatment (Arm 2) in the treatment of Vertebral Compression Fractures (VCFs) in patients with Multiple Myeloma. There is a Crossover Arm which is permitted when patients can crossover from Arm 1 to Arm 2 between 8 to 12 weeks after the sham procedure.
We would like to answer the following questions, would patients with multiple myeloma benefit more with surgical intervention, balloon kyphoplasty than patients with multiple myeloma that are being treated with conservative treatment alone.
We believe the relevance and importance of this research questions will change the future care and management of multiple myeloma patients. Currently patients that have been diagnoised with multiple myeloma, the vast majority of patients are being treated conservatively (non surgical management) and we believe the results of this study will have a positive impact on patients and reduce their patient, thus increase their quality of life and balloon kyphoplasty (medical device surgical intervention) will be used in the future of care for patients with multiple myeloma with the aim manage their symptoms.
Individuals that would be eligible for this study are patients that have been diagnosied with multiple myeloma patients with increased back pain (VAS greater or equal than 6).
This is a prospective study at a single site, the Royal National Orthopaedic Hospital NHS Trust. The duration of the study is 4 years, two years recruitment period and a 2 year follow up period for patients.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
15/LO/0094
Date of REC Opinion
3 Feb 2015
REC opinion
Unfavourable Opinion