Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma

NCT01410929 | Withdrawn Phase 4

• 1 other identifier: NCC-10-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Myeloma; Compression Fracture of Vertebral Column

Keywords

multiple myeloma; VCF; Vertebral Compression Fracture; Spine; Kyphoplasty; Back pain; Cancer

Outcome Measures

Primary Outcomes (1)

• Improvement in functional status, as measured by the Oswestry Disability Index (ODI)

  1 month

Secondary Outcomes (3)

• Change in Quality of Life (SF-35 Health Survey)

  1 month, 3 month

• Change in Back Pain (VAS)

  1 month, 3 month

• Change in Physical Disability associated with back pain (Roland-Morris Disability Questionnaire)

  1 month, 3 month

Interventions

Kyphoplasty/Vertebral Augmentation (Device-StabiliT) PROCEDURE

Targeted Vertebral Augmentation for the treatment of pathological fractures of the spine caused by multiple myeloma

Also known as: Targeted Vertebral Augmentation, Kyphoplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• DFINE Inc.: lead

MeSH Terms

Conditions

Multiple Myeloma; Back Pain; Neoplasms

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Frank Vrionis, MD, MPH, PhD

  H. Lee Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 5, 2011
• Study Start: May 1, 2011
• Last Updated: January 20, 2017

Record last verified: 2017-01