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A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures

21 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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.

Inclusion Criteria:

- Patients with multiple myeloma (active or smoldering) with mild back pain (Visual
Analog Scale [VAS]) ≤ 4 or no back pain (VAS=0) on a stable analgesic regimen)
related to vertebral compression fractures (at least one and up to 8 index fractures
from T3 to L5) as seen on magnetic resonancy imaging (MRI), computed axial tomography
(CT) scan or plain radiographs.

- No major planned spine surgery for at least 6 months following enrollment.

- No evidence of epidural disease or cord compromise on magnetic resonance imaging.

- Life expectancy greater than 6 months.

- Adequate myeloma systemic control (no evidence of active progressive disease). No
planned change in chemotherapy regimen for 1 month prior and for at least 1 month
following enrollment. Change in dose(s) permitted.

- Adequate hematologic parameters (platelet count≥50,000/μL, and absolute neutrophil
count ≥1,000). Platelet transfusions are permitted to increase platelet counts

- Age greater than 21 years and able to understand and sign the informed consent

Exclusion Criteria:

- Patients with significant comorbidities (aside from the index fracture or cancer)
which would result in an unacceptable surgical risk or patients with
contraindications to general or local anesthesia.

- Patients with other primary tumors including primary bone tumors or solitary
plasmacytoma at site of the index VCF.

- VCF morphology deemed unsuitable for balloon kyphoplasty (vertebra planum).

- Additional non-kyphoplasty surgical treatment is required for the index fracture.

- Patients with uncontrolled pain related to the VCF (VAS>4, or increasing opioid
requirements), or with epidural disease on magnetic resonance imaging. Spinal cord
compression , canal compromise and /or spinal instability requiring decompression.

- Patients with a bleeding disorder which cannot be adequately managed perioperatively.

- Patients with pain unrelated to the VCF according to the investigators.

- Patients with estimated survival less than 6 months.

- Known allergy to bone cement or all contrast media used in the treatment of study

- MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted
biostimulators, cochlear implants, penile prosthesis).

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Vertebral Event

Outcome Description:

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)

Outcome Time Frame:

Average of 12 months

Safety Issue:


Principal Investigator

Frank Vrionis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

May 2011

Related Keywords:

  • Multiple Myeloma
  • vertebral
  • compression
  • fracture
  • VCF
  • kyphoplasty
  • spine
  • Fractures, Bone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Fractures, Compression