WithdrawnPhase 4

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

0Started 2011-05

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: 1 month

Trial details

NCT IDNCT01410929

SponsorDFINE Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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