Multiple Myeloma Spinal Disease Study; A Multi-centre, Prospective, Single Blinded, Randomized, Controlled Study to Compare Conservative Management Alone Vs. Balloon Kyphoplasty With the Treatment of VCFs in Patients With Multiple Myeloma

Multiple myeloma (MM) accounts for 10% of the malignant haematological diseases and approximately 1% of all cancer-related deaths in Western countries. MM is characterised by the accumulation of malignant plasma cells in the bone marrow leading to impaired haematopoiesis and the highest incidence of bone involvement among the malignant diseases. MM bone disease is the result of increased destruction of bone that cannot be compensated for by new bone formation. Approximately 80% of patients with MM develop skeletal complications including bone pain, hypercalcemia, osteoporosis, osteolytic lesions and pathologic fractures. Vertebral fractures may be associated with spinal cord compression and neurological complications requiring surgery and/or radiotherapy. Osteolytic bone destruction is the most debilitating manifestation of MM, has a severe impact on patients' quality of life and is responsible for increased morbidity and mortality. Furthermore, bone resorption activity has been shown to be an independent risk factor for overall survival in patients with symptomatic MM. Moreover, myeloma-associated lytic bone lesions do not repair, even in patients who are disease free for years.

More than 50% of patients develop vertebral compression fractures (VCFs) either by the time of diagnosis or during the course of the diagnosed disease. These fractures can compromise the spinal cord and patients' height and stature, cause angulation of the spine, increasing sternum pressure, eventually resulting in sternal fractures and compromising the pulmonary capacity. 9% loss in predicted forced vital capacity is associated with each vertebral fracture. Deformity, Insomnia, depression, substantial physical, functional and psychological impairment and ultimately disability can be the result of severe vertebral compression fractures poorly managed at presentation.

Management of spinal MM bone disease

1. Bisphosphonates he use of bisphosphonates, which inhibit bone reabsorption, for the treatment of MM bone disease has led to an improvement in the quality of life for patients with MM.

2. Conservative (non-surgical) management (this is standard of care management for patients with multiple myeloma)

3. Pain relief

4. Systemic chemotherapy for Myeloma disease

5. Bed rest

6. Radiotherapy

7. Physiotherapy

8. Standard surgical procedures