- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01175278
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures
A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Observation Arm
Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.
|
|
Experimental: Balloon Kypholasty
|
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.
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Active Comparator: Control Arm
Non-surgical Management Treatment Group
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Average of 12 months
|
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
|
Average of 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Vertebral Events
Time Frame: 12 months
|
Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months
|
12 months
|
Rate of Hospitalization
Time Frame: 12 months
|
Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months
|
12 months
|
Complications of Procedure
Time Frame: Average of 12 months
|
Complications of vertebral augmentation
|
Average of 12 months
|
Quality of Life Questionnaire Results
Time Frame: Average of 12 months
|
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
|
Average of 12 months
|
Changes in Pulmonary Function
Time Frame: Average of 12 months
|
Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture
|
Average of 12 months
|
Change in Kyphosis
Time Frame: Average of 12 months
|
Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant
|
Average of 12 months
|
Prognostic Ability of Bone Biomarkers
Time Frame: Average of 12 months
|
Prognostic ability of bone biomarkers for the prediction of vertebral events
|
Average of 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frank Vrionis, M.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Fractures, Bone
- Wounds and Injuries
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Fractures, Compression
Other Study ID Numbers
- MCC-15839
- Pro00000214 (Other Identifier: USF Institutional Review Board)
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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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Vertebral Augmentation with Balloon Kyphoplasty
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DFINE Inc.WithdrawnMultiple Myeloma | Compression Fracture of Vertebral Column
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DFINE Inc.WithdrawnPainful Osteoporotic Vertebral Compression Fractures (VCF)United States
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Synthes GmbHCompletedVertebral Body FracturesGermany, Austria
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Vexim SAACES Ing.-GmbHCompletedOsteoporosis | Spinal Fractures | Back Injuries | Vertebral Compression FracturesSpain, France, Switzerland, Germany, Italy
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Crosstrees Medical Inc.CompletedPathologic Fracture of the Vertebra Due to OsteoporosisUnited States
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University of California, San FranciscoMedtronics, Inc.CompletedMultiple MyelomaUnited States
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Benvenue Medical, Inc.CompletedSpinal Fractures | Back Injuries | Fractures, CompressionUnited States, Canada, Germany, France, Belgium
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Medtronic Spine LLCCompletedMultiple Myeloma | Bone Neoplasms | Osteoporosis | OsteopeniaUnited States
-
Mayo ClinicCompleted
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Centre Leon BerardTerminatedSolid Tumors | Spine MetastasisFrance