A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures
This is a prospective single center study designed to compare balloon kyphoplasty to
non-surgical management (NSM) in the treatment of mildly painful, acute vertebral body
compression fractures in multiple myeloma patients. Because of the pilot nature and the
small sample size of the study, patient randomization will NOT be stratified. Patients with
mildly symptomatic vertebral compression fractures (VCFs) will undergo a 1:1 randomization
either balloon kyphoplasty or non surgical management. Randomization assignments will be
generated by computer and investigator notified once the patient enrolled.
The observational arm will be compared to each of the other two arms; control and
intervention arm using the same outcome variables and statistical methods.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Vertebral Event
Time to vertebral event (composite end point of pain progression, hospitalization for pain, and rescue vertebral augmentation or surgery or radiation therapy as related to an index fracture)
Average of 12 months
Frank Vrionis, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board