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Trial registered on ANZCTR


Registration number
ACTRN12618000659202
Ethics application status
Approved
Date submitted
17/04/2018
Date registered
24/04/2018
Date last updated
2/07/2019
Date data sharing statement initially provided
1/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Myeloma and Related Diseases Registry
Scientific title
Myeloma and Related Diseases Registry
Secondary ID [1] 294593 0
None
Universal Trial Number (UTN)
Trial acronym
MRDR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 307394 0
Plasmacytoma 307395 0
Plasma cell leukaemia 307396 0
Monoclonal gammopathy of undetermined significance (MGUS) 307397 0
Condition category
Condition code
Cancer 306498 306498 0 0
Myeloma
Blood 306576 306576 0 0
Other blood disorders
Inflammatory and Immune System 306579 306579 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The Myeloma and Related Diseases Registry (MRDR) is an ongoing register of patients with a new diagnosis of multiple myeloma, plasmacytoma, plasma cell leukaemia or monoclonal gammopathy of undetermined significance (MGUS). The MRDR was established in 2012 in Australia and New Zealand. In 2018, the MRDR will expand to the Asia-pacific region and include patients from Korea, Singapore, Taiwan and Hong Kong.
Intervention code [1] 300890 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305507 0
Overall survival post-diagnosis in multiple myeloma which is assessed by review of hospital records and linkage with national death databases.
Timepoint [1] 305507 0
6 monthly reporting post-diagnosis for a minimum of 5 years.
Primary outcome [2] 305508 0
Progression-free post diagnosis in multiple myeloma which is assessed by review of hospital records and linkage with national death databases.
Timepoint [2] 305508 0
6 monthly reporting post-diagnosis for a minimum of 5 years.
Secondary outcome [1] 345521 0
Time from diagnosis to chemotherapy in multiple myeloma.
Timepoint [1] 345521 0
6 monthly reporting post-diagnosis for a minimum of 5 years.
Secondary outcome [2] 345806 0
Quality of life which is assessed using the EQ-5D-5L questionnaire.

Timepoint [2] 345806 0
6 monthly reporting post-diagnosis for a minimum of 5 years.

Eligibility
Key inclusion criteria
Patients with a new diagnosis of multiple myeloma, plasmacytoma, plasma cell leukaemia or monoclonal gammopathy of undetermined significance (MGUS). Diagnosis within 3 months prior to HREC approval at a site for myeloma, plasmacytoma, plasma cell leukaemia and within 5 years for MGUS in order to minimise retrospective data collection.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who decline to participate in the registry.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Appropriate statistical methods are used in calculation of outcomes in routine registry reporting, including survival analysis for overall and progression-free survival. Other research analyses, reports and proposals are reviewed by the Steering Committee and by a suitably qualified statistician prior to data from the MRDR being analysed.
A detailed pre-determined statistical plan will be developed prior to planned analyses of registry data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 10648 0
The Alfred - Prahran
Recruitment hospital [2] 10650 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 10653 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 10655 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 10656 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 10658 0
The Northern Hospital - Epping
Recruitment hospital [7] 10660 0
St George Hospital - Kogarah
Recruitment hospital [8] 10661 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [9] 10662 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [10] 10663 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [11] 10665 0
The Canberra Hospital - Garran
Recruitment hospital [12] 10667 0
Box Hill Hospital - Box Hill
Recruitment hospital [13] 10668 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 10669 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [15] 10670 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [16] 10671 0
Concord Repatriation Hospital - Concord
Recruitment hospital [17] 10672 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [18] 10673 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [19] 10674 0
Icon Cancer Care Southport - Southport
Recruitment hospital [20] 10675 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [21] 10677 0
Epworth Freemasons - Melbourne
Recruitment hospital [22] 10678 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [23] 10748 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [24] 10749 0
Lismore Base Hospital - Lismore
Recruitment hospital [25] 10750 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [26] 10766 0
Frankston Hospital - Frankston
Recruitment hospital [27] 10767 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [28] 10768 0
Liverpool Hospital - Liverpool
Recruitment hospital [29] 10769 0
Sunshine Hospital - St Albans
Recruitment hospital [30] 13528 0
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [31] 13529 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 22370 0
3004 - Prahran
Recruitment postcode(s) [2] 22372 0
3084 - Heidelberg
Recruitment postcode(s) [3] 22375 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 22377 0
2050 - Camperdown
Recruitment postcode(s) [5] 22378 0
6009 - Nedlands
Recruitment postcode(s) [6] 22380 0
3076 - Epping
Recruitment postcode(s) [7] 22382 0
2217 - Kogarah
Recruitment postcode(s) [8] 22383 0
3000 - Melbourne
Recruitment postcode(s) [9] 22384 0
3168 - Clayton
Recruitment postcode(s) [10] 22385 0
3144 - Malvern
Recruitment postcode(s) [11] 22387 0
2605 - Garran
Recruitment postcode(s) [12] 22389 0
3128 - Box Hill
Recruitment postcode(s) [13] 22390 0
7000 - Hobart
Recruitment postcode(s) [14] 22391 0
5042 - Bedford Park
Recruitment postcode(s) [15] 22392 0
3844 - Traralgon
Recruitment postcode(s) [16] 22393 0
2139 - Concord
Recruitment postcode(s) [17] 22394 0
4101 - South Brisbane
Recruitment postcode(s) [18] 22395 0
4032 - Chermside
Recruitment postcode(s) [19] 22396 0
4215 - Southport
Recruitment postcode(s) [20] 22397 0
4066 - Auchenflower
Recruitment postcode(s) [21] 22398 0
3002 - Melbourne
Recruitment postcode(s) [22] 22474 0
4029 - Herston
Recruitment postcode(s) [23] 22475 0
2480 - Lismore
Recruitment postcode(s) [24] 22476 0
3220 - Geelong
Recruitment postcode(s) [25] 22494 0
3199 - Frankston
Recruitment postcode(s) [26] 22495 0
3065 - Fitzroy
Recruitment postcode(s) [27] 22496 0
2170 - Liverpool
Recruitment postcode(s) [28] 22497 0
3021 - St Albans
Recruitment postcode(s) [29] 26148 0
5037 - Kurralta Park
Recruitment postcode(s) [30] 26149 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 10282 0
Korea, Republic Of
State/province [1] 10282 0
Country [2] 10283 0
Singapore
State/province [2] 10283 0
Country [3] 10284 0
Taiwan, Province Of China
State/province [3] 10284 0
Country [4] 10285 0
Hong Kong
State/province [4] 10285 0
Country [5] 10286 0
New Zealand
State/province [5] 10286 0
Country [6] 21661 0
Malaysia
State/province [6] 21661 0

Funding & Sponsors
Funding source category [1] 299211 0
Commercial sector/Industry
Name [1] 299211 0
Janssen-Cilag Pty Limited
Address [1] 299211 0
1-5 Khartoum Road
Macquarie Park
NSW 2113
Country [1] 299211 0
Australia
Funding source category [2] 302375 0
Commercial sector/Industry
Name [2] 302375 0
Celgene International
Address [2] 302375 0
11 SARL, Rue des Moulins 4
2108 Couvet
Country [2] 302375 0
Switzerland
Funding source category [3] 302376 0
Commercial sector/Industry
Name [3] 302376 0
Glaxo Smith Kline
Address [3] 302376 0
1061 Mountain Highway
Boronia Victoria 3155
Country [3] 302376 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 298472 0
None
Name [1] 298472 0
Address [1] 298472 0
Country [1] 298472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300131 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 300131 0
Clayton Campus, Wellington Road, Clayton
Ethics committee country [1] 300131 0
Australia
Date submitted for ethics approval [1] 300131 0
Approval date [1] 300131 0
25/09/2012
Ethics approval number [1] 300131 0
CF12/2696 - 2012001463

Summary
Brief summary
This observational study is collecting information from patients to form the Myeloma and Related Diseases Registry (MRDR)

Who is it for?
You may be eligible for this study if you have a diagnosis of multiple myeloma, plasmacytoma, plasma cell leukaemia or monoclonal gammopathy of undetermined significance (MGUS).

Study details
Medical information including diagnostic tests, therapy and demographics will be provided by medical records. Participants can also provide information regarding their quality of life using a questionnaire.

It is hoped this registry will enable clinicians and hospitals to provide the best possible care to people with the included conditions and allow the evaluations of new therapies.
Trial website
https://mrdr.net.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82666 0
Prof Andrew Spencer
Address 82666 0
Attn: Myeloma and Related Diseases Registry
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road, Melbourne VIC 3004
Country 82666 0
Australia
Phone 82666 0
+61 3 9903 0355
Fax 82666 0
Email 82666 0
sphpm-myeloma@monash.edu
Contact person for public queries
Name 82667 0
Dr Elizabeth Moore
Address 82667 0
Attn: Myeloma and Related Diseases Registry
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road, Melbourne VIC 3004
Country 82667 0
Australia
Phone 82667 0
+61 3 9903 0355
Fax 82667 0
Email 82667 0
sphpm-myeloma@monash.edu
Contact person for scientific queries
Name 82668 0
Dr Elizabeth Moore
Address 82668 0
Attn: Myeloma and Related Diseases Registry
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road, Melbourne VIC 3004
Country 82668 0
Australia
Phone 82668 0
+61 3 9903 0355
Fax 82668 0
Email 82668 0
sphpm-myeloma@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
No directly identifying data will be shared. Health data collected during the study period, may be shared after de-identification, subject to relevant approvals.
When will data be available (start and end dates)?
Data is available. No end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal and who have approval from relevant human research ethics committees, the MRDR management team and MRDR steering committee.
Available for what types of analyses?
Only to achieve aims related to those listed in the approved proposal.
How or where can data be obtained?
Access subject to approvals by ethics Committees, MRDR management team and Steering Committee. De-identified data will be made available via a Data Safe Haven. Researchers will be required to sign a data access agreement.
What supporting documents are/will be available?
Study protocol
Summary results
No Results