None listed
Conditions
Brief summary
This study will investigate the real-world use of immunoglobulin therapy on clinical outcomes for patients with myeloma using the Australian and New Zealand Myeloma and Related Diseases Registry. Patients with the blood cancer myeloma are at risk of serious infection because of low levels of protective antibodies due to their condition and its treatment. Immunoglobulin therapy (made from plasma) is used to replace missing antibodies to prevent or treat infections in patients with blood cancers. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with multiple myeloma and participated in the Myeloma and Related Diseases Registry Study details This observational study will collect ‘real world’, up-to date Australian clinical and laboratory information on immunoglobulin use. Information on participants’ disease, progression, infections and immunoglobulin use will be documented in the registry at fixed time points after diagnosis. The results of this study will be important to provide better care for patients with myeloma and other blood cancers and to improve stewardship of the national blood supply. The study will also provide a new and lower cost framework for conducting future large clinical trials of immunoglobulin therapy in Australia in myeloma and in other similar conditions.
Interventions
Myeloma is a malignant tumour of the plasma cells that develops in the bone marrow and in solid bone. It is associated with anaemia, renal failure, bone lesions and disturbed immune function and is diagnosed in over 1500 people in Australia each year. It is more common in
males and the median age at diagnosis is 71. The incidence rate of myeloma has increased, and its prevalence is expected to further increase due to an ageing population and recent improvements in the overall survival of patient
Myeloma is a malignant tumour of the plasma cells that develops in the bone marrow and in solid bone. It is associated with anaemia, renal failure, bone lesions and disturbed immune function and is diagnosed in over 1500 people in Australia each year. It is more common in males and the median age at diagnosis is 71. The incidence rate of myeloma has increased, and its prevalence is expected to further increase due to an ageing population and recent improvements in the overall survival of patients with the disease. Whilst myeloma accounts for 1.3% of all cancers, it was one of the ten most common cancers diagnosed in women in Australia in 2012/13 and is associated with a high disease burden. The IMPROVE Study requires observational data to be entered into the MRDR Registry at specific time points after the patient’s date of diagnosis. Clinicians will review patients at any time that they feel is necessary, however, it is useful for the registries to have data collected and entered at fixed time points after diagnosis to allow for comparable statistical analysis across all sites. The time points are baseline, at 4-months, 8-months, 12-months, and 16-months. There is no pre-determined “schedule of assessments” given the variability of clinical progression of this disease.
Sponsors
Monash University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Newly diagnosed with multiple myeloma A participant in the MRDR Registry
Exclusion criteria
Patients who decline to participate Patients who do not have a diagnosis of multiple myeloma
Outcome results
None listed