None listed
Conditions
Brief summary
Brief description of the study purpose This study will examine the safety and efficacy of romosozumab (a drug to treat bone loss) in patients with multiple myeloma who have had a skeletal related event despite bisphosphonate therapy. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have been diagnosed with multiple myeloma and had a skeletal related event despite previous treatment with bisphosphonate therapy Study details All participants who choose to enrol in this study will receive an Romosozumab subcutaneously every 28 days for 12 cycles. Patients will also receive calcium and vitamin D supplementation. During and after completion of the treatment participants will be assessed for safety and effect of romosozumab. This will include monthly blood tests. A bone marrow biopsy will also be performed during screening for the study, following 12 months of treatment and at disease progression if this occurs during the study period. A CT skeletal survey will also be performed at screening and following 12 months of treatment and 12 months following completion of treatment. It is hoped that this research project will demonstrate that romosozumab is safe to administer to patients with multiple myeloma and identify any potential bone modifying effects of this drug in these patients
Interventions
Romosozumab 210mg will be administered subcutaneously by a nurse every 28 days for 12 doses.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Males or females with multiple myeloma Age 18 years or older. Skeletal related event with at least 3 doses of anti-resorptive therapy Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
Exclusion criteria
History of myocardial infarction or stroke in prior 12 months Women of child bearing potential Active unstable cardiovascular function Previous teriparatide or any parathyroid hormone (PTH) analogs History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget’s disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia and malabsorption syndrome Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 50nmol/L. Vitamin D repletion will be permitted and subjects may be rescreened Current hyper- or hypocalcemia Current, uncontrolled hyper- or hypothyroidism Current, uncontrolled hyper- or hypoparathyroidism, History of dental extraction or other invasive dental work within 3 years, or who require invasive dental work within the next two years or history of osteonecrosis of the jaw Life expectancy of less than 2 years. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
Outcome results
None listed