Trial Review

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Trial registered on ANZCTR


Registration number
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
Sex
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
1/06/2007
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
31/03/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
36
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 12942 0
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
[email protected]
Contact person for scientific queries
Name 3870 0
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
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIQUALITY OF LIFE ASSESSMENT IN MULTIPLE MYELOMA PATIENTS UNDERGOING DOSE-REDUCED TANDEM AUTOLOGOUS STEM CELL TRANSPLANTATION2011https://doi.org/10.4084/mjhid.2011.057
N.B. These documents automatically identified may not have been verified by the study sponsor.