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

January 18, 2017 updated by: DFINE Inc.
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in functional status, as measured by the Oswestry Disability Index (ODI)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life (SF-35 Health Survey)
Time Frame: 1 month, 3 month
1 month, 3 month
Change in Back Pain (VAS)
Time Frame: 1 month, 3 month
Visual Analog Scale for pain
1 month, 3 month
Change in Physical Disability associated with back pain (Roland-Morris Disability Questionnaire)
Time Frame: 1 month, 3 month
1 month, 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DFINE Inc.

Investigators

  • Principal Investigator: Frank Vrionis, MD, MPH, PhD, H. Lee Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-10-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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