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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
DFINE Inc.
ClinicalTrials.gov Identifier:
NCT01410929
First received: August 4, 2011
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

The objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Compression Fracture of Vertebral Column
Procedure: Kyphoplasty/Vertebral Augmentation (Device-StabiliT)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by DFINE Inc.:

Primary Outcome Measures:
  • Improvement in functional status, as measured by the Oswestry Disability Index (ODI) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Quality of Life (SF-35 Health Survey) [ Time Frame: 1 month, 3 month ] [ Designated as safety issue: No ]
  • Change in Back Pain (VAS) [ Time Frame: 1 month, 3 month ] [ Designated as safety issue: No ]
    Visual Analog Scale for pain

  • Change in Physical Disability associated with back pain (Roland-Morris Disability Questionnaire) [ Time Frame: 1 month, 3 month ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2011
Intervention Details:
    Procedure: Kyphoplasty/Vertebral Augmentation (Device-StabiliT)
    Targeted Vertebral Augmentation for the treatment of pathological fractures of the spine caused by multiple myeloma
    Other Names:
    • Targeted Vertebral Augmentation
    • Kyphoplasty
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 medications.
  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 enrollment
  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 enrollment
  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 planna)
  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 decompression
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410929

Sponsors and Collaborators
DFINE Inc.
Investigators
Principal Investigator: Frank Vrionis, MD, MPH, PhD H. Lee Moffitt Cancer Center
  More Information

No publications provided

Responsible Party: Frank D. Vrionis MD, MPH, PhD, H. Lee Moffitt Cancer Center
ClinicalTrials.gov Identifier: NCT01410929     History of Changes
Other Study ID Numbers: NCC-10-001
Study First Received: August 4, 2011
Last Updated: January 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by DFINE Inc.:
multiple myeloma
VCF
Vertebral Compression Fracture
Spine
Kyphoplasty
Back pain
Cancer

Additional relevant MeSH terms:
Fractures, Bone
Multiple Myeloma
Neoplasms, Plasma Cell
Spinal Fractures
Fractures, Compression
Wounds and Injuries
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on July 23, 2014