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Trial registered on ANZCTR


Trial ID
ACTRN12609000595213
Ethics application status
Approved
Date submitted
13/07/2009
Date registered
20/07/2009
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quality of life assessment and overall survival in patients with mulitple myeloma after Tandem Autologous Stem Cell Transplantation (ASCT)
Scientific title
Quality of life assessment and disease free survival and overall survival in patients with mulitple myeloma after Tandem Autologous Stem Cell Transplantation (ASCT)
Secondary ID [1] 288733 0
nil known
Universal Trial Number (UTN)
Trial acronym
MM TANDEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 236916 0
Condition category
Condition code
Cancer 237274 237274 0 0
Myeloma
Blood 239553 239553 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment of quality of life, tolerability and disease outcome in patients with multiple myeloma undergoing tandem autologous peripheral blood stem cell transplantation (PBSC). The two stem cell transplantation will be conducted 3 months apart with a regular follow up every thre months for 2 years following the second stem cell transplantation. Autologous peripheral blood stem cell transplantation is a technique in which stem cells are obtained from a patient's own peripheral blood stem cells and used after high-dose melphalan chemotherapy as stem cell transplantation. Previously cryopreserved stem cells are intravenously infused after thawing them into body tempertaure over approximately few minutes one day after the high-dose chemotherapy.
Intervention code [1] 236705 0
Treatment: Other
Comparator / control treatment
A comparison to other historical lines (from litertaure) of treatment of multiple myeloma will be made from 1990 to current. Furthermore comparison of stem cell transplantation to other alternative treatments administered in the historical groups as well as stem cell transplantation will be made.
Control group
Historical

Outcomes
Primary outcome [1] 238085 0
Study of the quality of life after tandem autologous stem cell tranplantataion in patients with multiple myeloma via regular quality of life assessment questionnaire
Timepoint [1] 238085 0
follow-up will be conducted every 8-12 weeks for the first 24 months after the second stem cell transplant.
Primary outcome [2] 238379 0
over all survival assessed during regular follow up.
Timepoint [2] 238379 0
24 months post second transplant
Secondary outcome [1] 242284 0
to study event (disease) free survival of myeloma patients after tandem stem cell transplantation via regular assessment of disease markers e.g. paraprotein level, serum free light chain and radiological evidence of lytic lesions.
Timepoint [1] 242284 0
follow-up will be conducted every 8-12 weeks for the first 24 months after the second stem cell transplant.
Secondary outcome [2] 244829 0
Assessement of the engraftment kinetics after each transplant via regular full blood count analysis.
Timepoint [2] 244829 0
4 weeks after each transplnat is typical time for recovery post transplant.

Eligibility
Key inclusion criteria
patients of either gender, 18 years and above who are able to give consent and have either: a confirmed diagnosis of multiple myeloma according to the World Health Organization (WHO) classification or patients who have been enrolled in our protocol with tandem stem cell transplantation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient with renal impairment defined by an estimated creatinine clearance below < 15 ml/min based on the Cockcroft-Gault formula. (Creatinine clearance = (140-age) x ideal body weight (IBW in Kg) (x 0.85 if female) / (Serum creatinine. x 0.815).
Advanced liver disease (Child C with encephalopathy, ascites and a significantly elevated bilirubin, or pre-treatment coagulopathy).
Patients with Eastern Cooperative Oncology Group (ECOG) status>2

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
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
Current
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 237095 0
Charities/Societies/Foundations
Name [1] 237095 0
Clifford Craig Medical Research Trust
Address [1] 237095 0
PO Box 1963 Launceston tasmania 7250
Country [1] 237095 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] 4599 0
Hospital
Name [1] 4599 0
Launceston General Hospital
Address [1] 4599 0
Charles Street, TAS, Launceston tasmania 7250
Country [1] 4599 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239194 0
Tasmania Health and Medical Human Research Ethics Committee EC00337
Ethics committee address [1] 239194 0
Executive Officer University of Tasmania Research and Development Office GPO Box 252-01 Hobart TAS 7001
Ethics committee country [1] 239194 0
Australia
Date submitted for ethics approval [1] 239194 0
Approval date [1] 239194 0
04/09/2007
Ethics approval number [1] 239194 0
H0009450

Summary
Brief summary
To study the Quality of Life Assessed by the European Organization of Reseach and Treatment of Cancer (EORTC) disease spesific module and disease free survival and overall survival in patients with mulitple myeloma after Tandem Autologous Stem Cell Transplantation (ASCT)
Assessment of patient: 1. Age and sex. 2. Stage of disease initially and at time of recruitment (according to the World Health Organization (WHO) Myeloma Staging System). 3. Type of myeloma disease (M protein): Paraprotein quantification, Serum free light chains, Bence Jones Protein quantification. 4. Skeletal Survey: documentation of all lytic lesions at time of diagnosis and recruitment. 5. Liver and kidney function, C-reactive protein (CRP), Erythrocyte sedmintation rate (ESR), Beta 2 microglobulin (B2M), serum Calcium will be determined at time of the study, and if possible, traced from time of diagnosis. 6. Bone marrow study will be traced from time of diagnosis and relapse when it is possible with documentation of plasma cell content in the bone marrow. 7. Cytogenetic studies will be offered for the patients during routine marrow test to determine the cytogenetic risk factors including 13q- and translocation t(4,14) and its correlation with disease outcome as per our registered trial ACTRN12609000594224.
8. All previous treatments received and response to each treatment should be documented. Monitoring and assessment of quality of life and pain: Quality of life assessment and symptoms, in particular pain, will be assessed quarterly (after initial assessment) and at the end of the study as per the EORTC quality of life questionnaire (QLQ-C30) with disease specific module. In the case of patient willingness to take part in the study, a written consent will be completed, after which the patient will be formally enrolled in the study. Follow-up will be conducted every 8-12 weeks for the first 24 months after the second stem cell transplant. A clinical assessment form will be filled out at each visit. A full patient profile will be obtained including such detail as medical and drug history, risk factors for multiple myeloma. The patient demographic and physical detail (weight, height etc) will be also measured and recorded. Other routine data and laboratory investigations including kidney and liver function will be recorded. All patients will be counselled that if they decide to withdraw from the study at any time, this will in no way affect their care or procedure at the treatment centre.
Trial website
Trial related presentations / publications
Khalafallah A, McDonnell K, Dawar HU, Robertson I, Woods D.
Quality of life assessment in multiple myeloma patients undergoing dose-reduced tandem autologous stem cell transplantation.
Mediterr J Hematol Infect Dis. 2011;3(1):e2011057. doi: 10.4084/MJHID.2011.057. Epub 2011 Nov 28.
PMID:22220254

http://www.ncbi.nlm.nih.gov/pubmed/22220254
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3248334/
Public notes

Contacts
Principal investigator
Name 29695 0
Prof Alhossain Khalafallah
Address 29695 0
, Launceston General Hospital, Launceston, Tasmania
Country 29695 0
Australia
Phone 29695 0
+61363487111
Fax 29695 0
Email 29695 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 12942 0
Prof Assoc. Prof. Alhossain Khalafallah
Address 12942 0
Heamatology Department
Launceston General Hospital
Charles St
Launceston Tas 7250
Country 12942 0
Australia
Phone 12942 0
+61 3 6348 7111
Fax 12942 0
Email 12942 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 3870 0
Prof Assoc. Prof. Alhossain Khalafallah
Address 3870 0
Heamatology Department
Launceston General Hospital
Charles St
Launceston Tas 7250
Country 3870 0
Australia
Phone 3870 0
+61 3 6348 7111
Fax 3870 0
Email 3870 0
khalafallah@dhhs.tas.gov.au