Multiple MyelomaNCT01175278
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures
A study testing Vertebral Augmentation with Balloon Kyphoplasty and Non-surgical Treatment in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute.
Trial summary
The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Vertebral Augmentation with Balloon Kyphoplasty and Non-surgical Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to May 2011
- Phase
- Interventional
- 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
- 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 perioperatively.
- Age greater than 21 years and able to understand and sign the informed consent document.
Who cannot join
- 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.
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- 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 participants.
- MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis).
About this study
Official title: A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures
The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- Vertebral Augmentation with Balloon Kyphoplasty, Non-surgical Treatment
- Keywords
- vertebral, compression, fracture, VCF, kyphoplasty, spine
- Medical subject headings
- Multiple Myeloma, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebral Augmentation with Balloon KyphoplastyProcedure or surgery
Two small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone.
Non-surgical TreatmentOther
Non-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s).
| Study group | Role | What they receive |
|---|---|---|
| Observation Arm | No intervention | Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study. |
| Balloon Kypholasty | Experimental | Not described Receives: Procedure: Vertebral Augmentation with Balloon Kyphoplasty |
| Control Arm | Active comparator | Non-surgical Management Treatment Group Receives: Other: Non-surgical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Vertebral Event
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)
Measured: Average of 12 months
Time to Pain Progression
Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture
Measured: Average of 12 months
Secondary outcomes (7)
Rate of Vertebral Events
Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months
Measured: 12 months
Rate of Hospitalization
Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months
Measured: 12 months
Complications of Procedure
Complications of vertebral augmentation
Measured: Average of 12 months
Quality of Life Questionnaire Results
Quality of life as assessed by the Functional Assessment of Cancer Treatment - General (FACT-G) questionnaire in all enrolled patients and Roland Morris disability questionnaire for spine disability
Measured: Average of 12 months
Changes in Pulmonary Function
Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture
Measured: Average of 12 months
Change in Kyphosis
Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant
Measured: Average of 12 months
Prognostic Ability of Bone Biomarkers
Prognostic ability of bone biomarkers for the prediction of vertebral events
Measured: Average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: No enrollment
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.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronics, Inc.
- Responsible party
- Sponsor
- Investigators
- Frank Vrionis, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175278
- Sponsor's protocol ID
- MCC-15839
- Other IDs
- Pro00000214
- Status last verified
- Jan 2012
- First submitted
- 3 Aug 2010
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures
- ClinicalTrials.gov ID
- NCT01175278
- Acronym / sponsor ID
- MCC-15839
- Conditions
- Multiple Myeloma
- Keywords
- vertebral, compression, fracture, VCF, kyphoplasty, spine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Medtronics, Inc.
- Study start
- Jul 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Aug 2010 (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 purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observation Arm | No intervention | –Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study. |
| Balloon Kypholasty | Experimental | Procedure: Vertebral Augmentation with Balloon Kyphoplasty |
| Control Arm | Active comparator | Other: Non-surgical TreatmentNon-surgical Management Treatment Group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Vertebral Augmentation with Balloon KyphoplastyTwo small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone. | Procedure or surgery | Balloon Kypholasty |
| Non-surgical TreatmentNon-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s). | Other | Control Arm |
Primary outcome
Time to Vertebral Event
Time frame: Average of 12 months
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)
Time to Pain Progression
Time frame: Average of 12 months
Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture
7 secondary outcomes
Rate of Vertebral Events
Time frame: 12 months
Rate of Hospitalization
Time frame: 12 months
Complications of Procedure
Time frame: Average of 12 months
Quality of Life Questionnaire Results
Time frame: Average of 12 months
Changes in Pulmonary Function
Time frame: Average of 12 months
Change in Kyphosis
Time frame: Average of 12 months
Prognostic Ability of Bone Biomarkers
Time frame: Average of 12 months
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 12 Jan 2012.
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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, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Vertebral Augmentation with Balloon Kyphoplasty and Non-surgical Treatment in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute.
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 7 inclusion and 10 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 12 Jan 2012. 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.
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?
Time to Vertebral Event (time frame: Average of 12 months). The study lists 2 primary outcomes in all. 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 12 Jan 2012.