Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001248156
Ethics application status
Approved
Date submitted
13/08/2019
Date registered
10/09/2019
Date last updated
30/03/2022
Date data sharing statement initially provided
10/09/2019
Date results information initially provided
30/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving national immunoglobulin stewardship and clinical outcomes for patients with myeloma
Scientific title
IMPROVE (Immunoglobulins in Myeloma Patients: Research into Outcomes, Variation in practice, and Epidemiology) – Improving immunoglobulin stewardship and clinical outcomes for patients with myeloma, using the Australian and New Zealand Myeloma and Related Diseases Registry.
Secondary ID [1] 299006 0
None
Universal Trial Number (UTN)
Trial acronym
IMPROVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 314015 0
Condition category
Condition code
Cancer 312404 312404 0 0
Myeloma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 315274 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321050 0
Composite Primary outcome: Number and type of infection episodes (viral, bacterial, fungal, not categorised), Data will be collected via study-specific case report forms.
Timepoint [1] 321050 0
Baseline, 4, 8, 12, and 16-months
Primary outcome [2] 321051 0
The number of microbiologically documented infections. Data will be collected via study-specific case report forms.
Timepoint [2] 321051 0
Baseline, 4, 8, 12, and 16-months
Secondary outcome [1] 374374 0
Number of Hospitalisations due to infection. Data will be collected via study-specific case report forms.
Timepoint [1] 374374 0
Baseline, 4, 8, 12, and 16-months

Eligibility
Key inclusion criteria
Newly diagnosed with multiple myeloma
A participant in the MRDR Registry
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who decline to participate
Patients who do not have a diagnosis of multiple myeloma

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/10/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
30/10/2020
Date of last data collection
Anticipated
31/07/2021
Actual
30/10/2020
Sample size
Target
300
Accrual to date
Final
328
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 14524 0
The Alfred - Melbourne
Recruitment hospital [2] 14525 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 14528 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [4] 14529 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 14535 0
Nepean Hospital - Kingswood
Recruitment hospital [6] 14536 0
The Northern Hospital - Epping
Recruitment hospital [7] 14537 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 22091 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [9] 22092 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 22093 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 27539 0
3004 - Melbourne
Recruitment postcode(s) [2] 27542 0
3065 - Fitzroy
Recruitment postcode(s) [3] 27543 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 27547 0
2747 - Kingswood
Recruitment postcode(s) [5] 27548 0
3076 - Epping
Recruitment postcode(s) [6] 27549 0
2065 - St Leonards
Recruitment postcode(s) [7] 37214 0
3084 - Heidelberg
Recruitment postcode(s) [8] 37215 0
7000 - Hobart
Recruitment postcode(s) [9] 37216 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 303541 0
Government body
Name [1] 303541 0
National Blood Authority
Country [1] 303541 0
Australia
Primary sponsor type
University
Name
Monash University
Address
553 St Kilda Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 303610 0
None
Name [1] 303610 0
Address [1] 303610 0
Country [1] 303610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304069 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 304069 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 304069 0
Australia
Date submitted for ethics approval [1] 304069 0
12/06/2018
Approval date [1] 304069 0
07/08/2018
Ethics approval number [1] 304069 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95714 0
Prof Erica Wood
Address 95714 0
Public Health and Preventive Medicine
Monash University
553 St Kilda rd, Melbourne VIC, 3004
Country 95714 0
Australia
Phone 95714 0
+613 99030051
Fax 95714 0
Email 95714 0
[email protected]
Contact person for public queries
Name 95715 0
Dr Laura Sellick
Address 95715 0
Public Health and Preventive Medicine
Monash University
553 St Kilda rd, Melbourne VIC, 3004
Country 95715 0
Australia
Phone 95715 0
+61 3 99030251
Fax 95715 0
Email 95715 0
[email protected]
Contact person for scientific queries
Name 95716 0
Prof Erica Wood
Address 95716 0
Public Health and Preventive Medicine
Monash University
553 St Kilda rd, Melbourne VIC, 3004
Country 95716 0
Australia
Phone 95716 0
+613 99030051
Fax 95716 0
Email 95716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No, only aggregate participant data will be published


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.