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Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma

Phase 4
21 Years
Not Enrolling
Multiple Myeloma, Compression Fracture of Vertebral Column

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Trial Information

Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma

Myeloma is the commonest primary cancer affecting the spine. Painful vertebral compression
fractures (VCFs) affect approximately 30% of myeloma patients. As myeloma patients live
longer, it is especially relevant to provide the best available treatment for pain and
reduce disabilities that can result from VCFs.

Cement delivery is a well established treatment method for treating painful vertebrae
compromised by tumor and/or osteoporosis. The StabiliT Vertebral Augmentation System (DFine
Inc.) is a unique percutaneous vertebral augmentation system designed to provide the
physician a means of creating targeted cavities and an ultra-high viscosity cement (using RF
Energy) that can be delivered over an extended period of time in order to allow for
controlled, targeted vertebral augmentation in multiple myeloma patients.

Inclusion Criteria:

1. Diagnosis of multiple myeloma and evidence of myelomatous lesions in the spine,
including plasmacytomas, lytic lesions and fractures.

2. One to 6 painful (pain on palpation/percussion over fractured vertebral body) VCF(s),
T3-L5, with bone marrow edema imaged by magnetic resonance imaging (MRI) (Subjects
with 4-6 fractures treatment will be divided into two sessions 1- 7 days apart)

3. History of fracture related pain less than ≤ 3 months old

4. Pain VAS score ≥4 on a scale of 0 to 10. When the subject is newly diagnosed with
multiple myeloma, the pain assessment must not be done until after completion of at
least one pulse of steroid therapy or one week after the initiation of active
multiple myeloma chemotherapy. Pain represents worst pain without use of narcotic

5. Roland Morris Disability Questionnaire score ≥ 10 on 0 to 24 scale

6. Subjects is ≥ 21 years old.

7. No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to

8. No change in chemotherapy regimen (change in dose(s) permitted) planned for at least
1 month following enrollment

9. Subject has no major surgery to the spine planned for at least 1 month following

10. Subject has sufficient mental capacity to comply with the protocol requirements

11. Subject must be willing and able to comply with specified follow-up evaluations

12. Subject understands the potential risks and benefits of participating in the study
and is willing to provide written informed consent.

13. Female subjects must either be no longer capable of reproduction or taking acceptable
measures to prevent pregnancy during the study

Exclusion Criteria:

1. Subjects with primary tumors of the bone (e.g., osteosarcoma) or osteoblastic
metastases at site of the index VCF. Subjects with these tumors in anatomic sites
other than the index VCF are eligible.

2. Subject is concurrent Phase I investigational anti-cancer treatment

3. Subject has significant clinical morbidities (aside from the index fracture(s) and
cancer) that may potentially interfere with the collection of data concerning pain
and function

4. Subject has VCF morphology deemed unsuitable for RF Kyphoplasty (e.g. vertebral

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

6. Subjects requiring the use of high-dose steroid (≥ 100 mg prednisone or 20 mg
dexamethasone per day), intravenous (IV) pain medication, or nerve block to control
chronic back pain unrelated to index VCF(s). Subjects who receive high-dose steroids
for treatment of their cancer (for at least 30 days) are eligible.

7. Subjects with a platelet count of < 20,000

8. Subject has spinal cord compression or significant canal compromise requiring

9. Subjects with VCFs due to osteoporosis

10. Subject has medical/surgical conditions contrary to the kyphoplasty procedure (e.g.,
in the presence of active or incompletely treated local infection)

11. Positive baseline pregnancy test (for women of child-bearing potential)

12. Subject has neurologic deficit associated with the level(s) to be treated more severe
than radiculopathy (e.g. myelopathy, cauda equina syndrome)

13. Subject has segmental kyphosis > 30° in area of treatment

14. Subject has uncontrolled coagulopathy

15. Subject cannot temporarily discontinue anticoagulation therapy

16. Subject has a known allergy to device materials / PMMA

17. Index VCF was exposed to high energy trauma

18. Subject has severe cardiopulmonary deficiencies as contra-indication to local or
general anesthesia required for the procedure.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement in functional status, as measured by the Oswestry Disability Index (ODI)

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Frank Vrionis, MD, MPH, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2011

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Compression Fracture of Vertebral Column
  • multiple myeloma
  • VCF
  • Vertebral Compression Fracture
  • Spine
  • Kyphoplasty
  • Back pain
  • Cancer
  • Fractures, Bone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Spinal Fractures
  • Fractures, Compression