Multiple MyelomaPhase 4MMNCT01410929
Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma
A Phase 4 study testing Kyphoplasty/Vertebral Augmentation (Device-StabiliT) in people with Multiple Myeloma and Compression Fracture of Vertebral Column, run by DFINE Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma, Compression Fracture of Vertebral Column
- What is being tested?
- Kyphoplasty/Vertebral Augmentation (Device-StabiliT)
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2011to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple myeloma and evidence of myelomatous lesions in the spine, including plasmacytomas, lytic lesions and fractures.
- 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)
- History of fracture related pain less than ≤ 3 months old
- 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.
- Roland Morris Disability Questionnaire score ≥ 10 on 0 to 24 scale
- Subjects is ≥ 21 years old.
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- No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment
- No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1 month following enrollment
- Subject has no major surgery to the spine planned for at least 1 month following enrollment
- Subject has sufficient mental capacity to comply with the protocol requirements
- Subject must be willing and able to comply with specified follow-up evaluations
- Subject understands the potential risks and benefits of participating in the study and is willing to provide written informed consent.
- Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study
Who cannot join
- 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.
- Subject is concurrent Phase I investigational anti-cancer treatment
- 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
- Subject has VCF morphology deemed unsuitable for RF Kyphoplasty (e.g. vertebral planna)
- Additional non-kyphoplasty surgical treatment is required for the index fracture
- 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.
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- Subjects with a platelet count of < 20,000
- Subject has spinal cord compression or significant canal compromise requiring decompression
- Subjects with VCFs due to osteoporosis
- Subject has medical/surgical conditions contrary to the kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)
- Positive baseline pregnancy test (for women of child-bearing potential)
- Subject has neurologic deficit associated with the level(s) to be treated more severe than radiculopathy (e.g. myelopathy, cauda equina syndrome)
- Subject has segmental kyphosis > 30° in area of treatment
- Subject has uncontrolled coagulopathy
- Subject cannot temporarily discontinue anticoagulation therapy
- Subject has a known allergy to device materials / PMMA
- Index VCF was exposed to high energy trauma
- Subject has severe cardiopulmonary deficiencies as contra-indication to local or general anesthesia required for the procedure.
About this study
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.
Read the 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.
- Being tested
- Kyphoplasty/Vertebral Augmentation (Device-StabiliT)
- Keywords
- multiple myeloma, VCF, Vertebral Compression Fracture, Spine, Kyphoplasty, Back pain, Cancer
- Medical subject headings
- Multiple Myeloma, Back Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyphoplasty/Vertebral Augmentation (Device-StabiliT)Procedure or surgery
Also called Targeted Vertebral Augmentation, Kyphoplasty
Targeted Vertebral Augmentation for the treatment of pathological fractures of the spine caused by multiple myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in functional status, as measured by the Oswestry Disability Index (ODI)
Measured: 1 month
Secondary outcomes (3)
Change in Quality of Life (SF-35 Health Survey)
Measured: 1 month, 3 month
Change in Back Pain (VAS)
Visual Analog Scale for pain
Measured: 1 month, 3 month
Change in Physical Disability associated with back pain (Roland-Morris Disability Questionnaire)
Measured: 1 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DFINE Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Vrionis, MD, MPH, PhD, Principal investigator, H. Lee Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410929
- Sponsor's protocol ID
- NCC-10-001
- Acronym
- MM
- Status last verified
- Jan 2017
- First submitted
- 4 Aug 2011
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01410929
- Acronym / sponsor ID
- MM / NCC-10-001
- Keywords
- multiple myeloma, VCF, Vertebral Compression Fracture, Spine, Kyphoplasty, Back pain, Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DFINE Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- First posted
- 5 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of multiple myeloma and evidence of myelomatous lesions in the spine, including plasmacytomas, lytic lesions and fractures.
- 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)
- History of fracture related pain less than ≤ 3 months old
- 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.
- Roland Morris Disability Questionnaire score ≥ 10 on 0 to 24 scale
Key exclusion criteria (18 listed)
- 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.
- Subject is concurrent Phase I investigational anti-cancer treatment
- 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
- Subject has VCF morphology deemed unsuitable for RF Kyphoplasty (e.g. vertebral planna)
- Additional non-kyphoplasty surgical treatment is required for the index fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kyphoplasty/Vertebral Augmentation (Device-StabiliT)Also: Targeted Vertebral Augmentation, KyphoplastyTargeted Vertebral Augmentation for the treatment of pathological fractures of the spine caused by multiple myeloma | Procedure or surgery | – |
Primary outcome
Improvement in functional status, as measured by the Oswestry Disability Index (ODI)
Time frame: 1 month
3 secondary outcomes
Change in Quality of Life (SF-35 Health Survey)
Time frame: 1 month, 3 month
Change in Back Pain (VAS)
Time frame: 1 month, 3 month
Change in Physical Disability associated with back pain (Roland-Morris Disability Questionnaire)
Time frame: 1 month, 3 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Vrionis, MD, MPH, PhD principal investigator
H. Lee Moffitt Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kyphoplasty/Vertebral Augmentation (Device-StabiliT) in people with Multiple Myeloma and Compression Fracture of Vertebral Column, run by DFINE Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in functional status, as measured by the Oswestry Disability Index (ODI) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.