Multiple Myeloma Clinical Trial

CAFE Study – Cancer Patient Fracture Evaluation

Summary

The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.

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Full Description

1. STUDY OBJECTIVES AND ENDPOINTS

1.1. Objectives

The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer.

1.2. Primary Endpoint

The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.

1.3. Secondary Endpoints

The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit.

Safety:

Rate of study treatment-related adverse events
Change in neurological status

Clinical:

Change in functional status as assessed with Karnofsky Performance Scale
Change in quality of life as assessed by the SF-36v2™ Health Survey
Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS)
Change in back-pain analgesics used
Change in ambulation status
Changes in activities of daily living
Time to treatment failure

Radiographic:

Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory
Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab

In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a fracture imaged by plain radiographs using the method of Genant

Pain NRS score ≥4 on a scale of 0 to 10

When the patient 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 therapy.
Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24
Patients must be at least 21 years old.
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
No major surgery to the spine planned for at least 1 month following enrollment
Life expectancy of ≥ 3 months
Patient has sufficient mental capacity to comply with the protocol requirements
Patient has stated availability for all study visits
Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.

Exclusion Criteria:

Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
Concurrent Phase I investigational anti-cancer treatment
Significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function
VCF morphology deemed unsuitable for balloon kyphoplasty
Additional non-kyphoplasty surgical treatment is required for the index fracture
Patients 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). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
Patients with a platelet count of < 20,000 measured at the time of hospital admission for the procedure
Spinal cord compression or canal compromise requiring decompression
Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors outside of vertebral levels intended for kyphoplasty may be enrolled.
Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)
Known allergy to bone cement or contrast medium used in the treatment of study subjects
MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
Positive baseline pregnancy test (for women of child-bearing potential)
Patients who may require allogeneic bone marrow transplantation during the course of the study.

Other Reasons for Lack of Enrollment:

A. Patient is afraid to have surgery

B. Patient is afraid to have anesthesia

C. Patient/family is not willing to participate in research

D. Patient is not willing to be randomized

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

134

Study ID:

NCT00211237

Recruitment Status:

Completed

Sponsor:

Medtronic Spine LLC

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There are 14 Locations for this study

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Valley Radiology Inc., UCSD
Escondido California, 92025, United States
Boulder Neurosurgical Associates
Boulder Colorado, 80304, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Sibley Memorial Hospital
Chevy Chase Maryland, 20815, United States
Greater Oncology Associates
Silver Spring Maryland, 20910, United States
Karmanos Cancer Center
Detroit Michigan, 48201, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah
Salt Lake City Utah, 84132, United States
St. Vincent's Hospital
Fitzroy Victoria, 3065, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Institut Jules Bordet
Brussels , , Belgium
Foothills Hospital
Calgary Alberta, T2N2T, Canada
Toronto Western Hospital
Toronto Ontario, M5T 2, Canada
Montreal General Hospital
Montreal Quebec, H3G 1, Canada
Charité Virchow-Klinikum
Berlin , , Germany
Medizinische Hochschule
Hannover , , Germany
National Center for Spinal Disorders
Budapest , , Hungary
Akademiska Sjukhuset
Uppsala , , Sweden
Royal London
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

134

Study ID:

NCT00211237

Recruitment Status:

Completed

Sponsor:


Medtronic Spine LLC

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