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Trial registered on ANZCTR


Registration number
ACTRN12612000024842
Ethics application status
Approved
Date submitted
23/12/2011
Date registered
6/01/2012
Date last updated
8/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of the outcome of patients with myeloma nephropathy on treatment with High Cut Off Haemodialysis (HCO-HD) in addition to chemotherapy at the Launceston General Hospital
Scientific title
Study of the outcome of patients with myeloma nephropathy on treatment with High Cut Off Haemodialysis (HCO-HD) in addition to chemotherapy at the Launceston General Hospital
Secondary ID [1] 279645 0
none
Universal Trial Number (UTN)
none
Trial acronym
HCO-HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 285443 0
Condition category
Condition code
Blood 285628 285628 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To assess the effectiveness of high cut off haemodialysis (HCOD) daily for 8 hours until the serum free light chain level become below 500 mg/L, in addition to chemotherapy in light chain myltiple myeloma disease patients who present at the Launceston General Hospital (LGH) and treated conjointly by the the Haematology and Renal teams. The observation time is 12 months per patient following tretment.
Intervention code [1] 283929 0
Not applicable
Comparator / control treatment
Patients with multiple myeloma and renal failure in compensatory phase who do not require dialysis.The observation time is at least12 months after completion of HCOD treatment for each patient with overall study period commencing from January 2009 till Dec 2013.
Control group
Historical

Outcomes
Primary outcome [1] 286188 0
Myeloma active parameters: amount of light chain disease, bone marrow disease, lytic lesions, hypercalcaemia and renal function.

Assessed by serum free light chain, calcium level, bone marrow biopsy, radiological imaging and kidney function test
Timepoint [1] 286188 0
These will be assessed continously until the end of the study.
Secondary outcome [1] 295332 0
Disease outcome.
Assessed by overall disease remission status and survival rate
Timepoint [1] 295332 0
These will be assessed continously until the end of the study.

Eligibility
Key inclusion criteria
Patients with multiple myeloma who have a light chain disease and renal impairment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients who have low light chain disease that not cause renal impairment

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
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)
TAS

Funding & Sponsors
Funding source category [1] 284422 0
Hospital
Name [1] 284422 0
Launceston General Hospital
Address [1] 284422 0
Charles street Launceston, Tasmania 7250 Australia
Country [1] 284422 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Trust Fund
Address
Level 5 Launceston General Hospital Charles street Launceston, Tasmania 7250 Australia
Country
Australia
Secondary sponsor category [1] 283350 0
None
Name [1] 283350 0
Address [1] 283350 0
Country [1] 283350 0
Other collaborator category [1] 260412 0
University
Name [1] 260412 0
School of Human Life Sciences
Address [1] 260412 0
University of Tasmania,
Newnham Campus, Tasmania, 7249, Australia
Country [1] 260412 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286397 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 286397 0
University of Tasmania Private Bag 01 Hobart, Tas 7001 Australia
Ethics committee country [1] 286397 0
Australia
Date submitted for ethics approval [1] 286397 0
Approval date [1] 286397 0
21/11/2011
Ethics approval number [1] 286397 0
H12160

Summary
Brief summary
Light chain myeloma commonly associated with renal failure. Therefore, it is important to preserve the renal function early by applying high cut off haemodialysis.
It is worthwhile to asses the effectiveness of the combination of high cut off haemodialysis (HCO-HD) in addition of chemotherapy
We are aiming to increase the awareness of this new treatment and also to document the results of the patients received this treatment in the last few years until end of next year.
Trial website
Trial related presentations / publications
Khalafallah AA, Loi SW, Love S, Mohamed M, Mace R, Khalil R, Girgs M, Raj R, Mathew M.
Early Application of High Cut-Off Haemodialysis for de-Novo Myeloma Nephropathy is Associated with Long-Term Dialysis-Independency and Renal Recovery. Mediterr J Hematol Infect Dis. 2013;5(1):e2013007. doi: 10.4084/MJHID.2013.007. Epub 2013 Jan 2. PMID: 23350020
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552781/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552781/pdf/mjhid-5-1-e2013007.pdf
Public notes

Contacts
Principal investigator
Name 33564 0
Prof Professor Alhossain Khalafallah
Address 33564 0
Launceston General Hospital
Charles Street
TAS 7250 Australia
Country 33564 0
Australia
Phone 33564 0
+61367776777
Fax 33564 0
Email 33564 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 16811 0
Prof Professor Alhossain A. Khalafallah
Address 16811 0
Launceston General Hospital Charles Street, Launceston, TAS 7250
Country 16811 0
Australia
Phone 16811 0
+61373487111
Fax 16811 0
+61373487695
Email 16811 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 7739 0
Prof Professor Alhossain A. Khalafallah
Address 7739 0
Launceston General Hospital Charles Street, Launceston, TAS 7250
Country 7739 0
Australia
Phone 7739 0
+61373487111
Fax 7739 0
+61373487695
Email 7739 0
khalafallah@dhhs.tas.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary