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Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures

Primary Purpose

Multiple Myeloma

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Vertebral Augmentation with Balloon Kyphoplasty

Non-surgical Treatment

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring vertebral, compression, fracture, VCF, kyphoplasty, spine

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Observation Arm

Balloon Kypholasty

Control Arm

Arm Description

Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.

Non-surgical Management Treatment Group

Outcomes

Primary Outcome Measures

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)

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

Secondary Outcome Measures

Rate of Vertebral Events

Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months

Rate of Hospitalization

Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months

Complications of Procedure

Complications of vertebral augmentation

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

Changes in Pulmonary Function

Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture

Change in Kyphosis

Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant

Prognostic Ability of Bone Biomarkers

Prognostic ability of bone biomarkers for the prediction of vertebral events

Full Information

NCT ID

NCT01175278

First Posted

August 3, 2010

Last Updated

January 11, 2012

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Medtronics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01175278

Brief Title

Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures

Official Title

A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Withdrawn

Why Stopped

No enrollment

Study Start Date

July 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Medtronics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

vertebral, compression, fracture, VCF, kyphoplasty, spine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Observation Arm

Arm Type

No Intervention

Arm Description

Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.

Arm Title

Balloon Kypholasty

Arm Type

Experimental

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

Non-surgical Management Treatment Group

Intervention Type

Procedure

Intervention Name(s)

Vertebral Augmentation with Balloon Kyphoplasty

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Non-surgical Treatment

Intervention Description

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).

Primary Outcome Measure Information:

Title

Time to Vertebral Event

Description

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 Frame

Average of 12 months

Title

Time to Pain Progression

Description

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

Time Frame

Average of 12 months

Secondary Outcome Measure Information:

Title

Rate of Vertebral Events

Description

Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months

Time Frame

12 months

Title

Rate of Hospitalization

Description

Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months

Time Frame

12 months

Title

Complications of Procedure

Description

Complications of vertebral augmentation

Time Frame

Average of 12 months

Title

Quality of Life Questionnaire Results

Description

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

Time Frame

Average of 12 months

Title

Changes in Pulmonary Function

Description

Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture

Time Frame

Average of 12 months

Title

Change in Kyphosis

Description

Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant

Time Frame

Average of 12 months

Title

Prognostic Ability of Bone Biomarkers

Description

Prognostic ability of bone biomarkers for the prediction of vertebral events

Time Frame

Average of 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Vrionis, M.D.

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures

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