Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000594224
Ethics application status
Approved
Date submitted
13/07/2009
Date registered
17/07/2009
Date last updated
17/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of chromosomal abnormalities by fluorescent in-situ-hyberdisation (FISH), and quantitative polymerase chain reaction (qPCR) in Multiple Myeloma patients and correlations with treatment outcomes.
Scientific title
A pilot study for chromosomal abnormalities by fluorescent in-situ-hyberdisation (FISH), and quantitative polymerase chain reaction (qPCR) in Multiple Myeloma patients and correlations with treatment outcomes.
Universal Trial Number (UTN)
Trial acronym
CAMM (Chromosomal abnormalities in Multiple Myeloma)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chromosomal Abnormalities in Multiple Myeloma 236922 0
Condition category
Condition code
Cancer 237280 237280 0 0
Myeloma
Blood 239551 239551 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Multiple Myeloma (MM) is a plasma cell dyscrasia resulting in high levels of monoclonal immunoglobulin (Ig) production leading to immunosuppression and other physiological disturbances.
A median survival of about 2 years is usually obtained with conventional chemotherapy, however trials using
high-dose therapy with subsequent autologous stem cell rescue have improved the remission rate, event-free survival, and overall survival (OS) in certain cohorts of patients. Various chromosomal abnormalities have been reported in MM patients but the 13q- and t(4:14) abnormalities are present in over 50% of abnormal plasma cells in these patients though the clinical significance of this has not been elucidated. Reports have linked the presence of the 13q- abnormality with
altered therapeutic responses to common treatments.
Strong evidence now indicates that conventional cytogenetics fails to recognise about 50% of these abnormalities because of slow growth of MM cells in cell culture as compared to fluorescence in situ hyberdisation (FISH) or quantitative polymerase chain reaction (qPCR). Both techniques are representing molecular high technology methods studying and amplifying both cell nuecleus ontent Deoxyribonucleic acid (DNA) and Ribonucleic acid (RNA) of myeloma cells. Furthermore FISH detects chromosomal aberration in both actively dividing cells and interphase nuclei.
Therefore our approach utilises patients blood and bone marrow samples at time of diagnosis or relapse assessed by commercially available probes for FISH analysis on CD 138+ cells and
reliably detects the prognostically significant genomic aberration, thus allowing clinicians to assess the
biological risk of disease progression in patients with multiple myeloma (MM). The bone marrow studies will be performed as part of routine investigations for myeloma with extra 10 ml sample to conduct this research. The procedure takes approximately 30 min.
This project will involve the validation of Fluorescence In-Situ Hybridisation (FISH) analysis of the 13q- and t(4:14) chromosomal abnormalities and development of rapid qPCR assays for the detection of these chromosomal abnormalities in bone marrow samples from denovo patients with MM.
The aim of this project is to develop rapid qPCR assays for analysis of 13q- and t(4:14) chromosomal abnormalities and correlate the frequency of these abnormalities with treatment modalities and outcomes.
The impact of these abnormalities in the context of high-dose therapy (HDT) or conventional therapy will help to identify those patients who would maximally benefit from HDT and those who would be refractory to HDT and might benefit from other therapeutic options.
The Launceston General Hospital (LGH) is a tertiary referral centre of North and North West of Tasmania. We currently have at the LGH, 35-40 patients diagnosed with multiple myeloma with approximately 15-20 new cases every year and this observationall study will run for a total of 4 years ending in Dec 2011.
Intervention code [1] 236711 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238093 0
This study aims at evaluating the prognostic value of chromosome 13 deletions as well as t(4,14) as detected
by the FISH/qPCR techniques in multiple myeloma patients. The impact of these abnormalities in the context of high-dose therapy (HDT) or conventional therapy will help to identify those patients who would maximallybenefit from HDT and those who would be refractory to HDT and might benefit from other therapeutic options.
Timepoint [1] 238093 0
at diagnosis of multiple myeloma or at time of relapse of the disease
Secondary outcome [1] 244828 0
Study of the prevalence of these chromosomal abnormalities in newly diagnosed and relapsed multiple myeloma.
Timepoint [1] 244828 0
yearly for 4 years ending in Dec 2011.

Eligibility
Key inclusion criteria
Patients who are newly diagnosed with multiple myeloma or who has relpased multiple myeloma and are above 18 years old.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years. Since this is an observational study, no other exclusion criteria.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237099 0
Charities/Societies/Foundations
Name [1] 237099 0
Clifford Craig Medical Research Trust
Country [1] 237099 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Research Trust
Address
PO Box 1963
Launceston
Tasmania 7250
Country
Australia
Secondary sponsor category [1] 236814 0
Hospital
Name [1] 236814 0
Launceston General Hospital
Address [1] 236814 0
Charels Street, Launceston, Tasmania
Country [1] 236814 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239198 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 239198 0
Executive officer
University of Tasmania (UTAS) Research and Development Office
GPO Box 252-01
Hobart
Tasmania 7001
Ethics committee country [1] 239198 0
Australia
Date submitted for ethics approval [1] 239198 0
Approval date [1] 239198 0
12/09/2007
Ethics approval number [1] 239198 0
H0009451

Summary
Brief summary
This study aims at evaluating the prognostic value of chromosome 13 deletions as well as t(4,14) as detected
by the FISH/qPCR techniques in multiple myeloma patients. The impact of these abnormalities in the context of high-dose therapy (HDT) or conventional therapy will help to identify those patients who would maximally benefit from HDT and those who would be refractory to HDT and might benefit from other therapeutic options.
Furthermore, it would be of great value for determining the prognosis of the disease to study the prognostic factors of myeloma, including -13q and t(4;14), at the time of diagnosis, prior to and after transplantation, and at the time of relapse, with special emphasis on the outcome of patients who underwent HDT.
Moreover, these data might supply valuable guidance regarding identification and cloning of a MM-tumour
suppressor gene.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29701 0
Address 29701 0
Country 29701 0
Phone 29701 0
Fax 29701 0
Email 29701 0
Contact person for public queries
Name 12948 0
Assoc Prof Alhossain Khalafallah
Address 12948 0
Launceston General Hospital
Charles St
Launceston
Tasmania 7250
Country 12948 0
Australia
Phone 12948 0
+61 3 6348 7111
Fax 12948 0
Email 12948 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 3876 0
Assoc Prof Alhossain Khalafallah
Address 3876 0
Launceston General Hospital
Charles St
Launceston
Tasmania 7250
Country 3876 0
Australia
Phone 3876 0
+61 3 6348 7111
Fax 3876 0
Email 3876 0
+61 3 6348 7111

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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