ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

MM TANDEM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple Myeloma

Condition category

Condition code

Cancer

Myeloma

Blood

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]

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]

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]

follow-up will be conducted every 8-12 weeks for the first 24 months after the second stem cell transplant.

Primary outcome [2]

over all survival assessed during regular follow up.

Timepoint [2]

24 months post second transplant

Secondary outcome [1]

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]

follow-up will be conducted every 8-12 weeks for the first 24 months after the second stem cell transplant.

Secondary outcome [2]

Assessement of the engraftment kinetics after each transplant via regular full blood count analysis.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Medical Research Trust

Address [1]

PO Box 1963 Launceston tasmania 7250

Country [1]

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]

Hospital

Name [1]

Launceston General Hospital

Address [1]

Charles Street, TAS, Launceston tasmania 7250

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmania Health and Medical Human Research Ethics Committee EC00337

Ethics committee address [1]

Executive Officer University of Tasmania Research and Development Office GPO Box 252-01 Hobart TAS 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/09/2007

Ethics approval number [1]

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

Prof Alhossain Khalafallah

Address

, Launceston General Hospital, Launceston, Tasmania

Country

Australia

Phone

+61363487111

Fax

khalafallah@dhhs.tas.gov.au

Contact person for public queries

Name

Assoc. Prof. Alhossain Khalafallah

Address

Heamatology Department
Launceston General Hospital
Charles St
Launceston Tas 7250

Country

Australia

Phone

+61 3 6348 7111

Fax

khalafallah@dhhs.tas.gov.au

Contact person for scientific queries

Name

Assoc. Prof. Alhossain Khalafallah

Address

Heamatology Department
Launceston General Hospital
Charles St
Launceston Tas 7250

Country

Australia

Phone

+61 3 6348 7111

Fax

khalafallah@dhhs.tas.gov.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	QUALITY OF LIFE ASSESSMENT IN MULTIPLE MYELOMA PATIENTS UNDERGOING DOSE-REDUCED TANDEM AUTOLOGOUS STEM CELL TRANSPLANTATION	2011	https://doi.org/10.4084/mjhid.2011.057

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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