Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000382471
Ethics application status
Approved
Date submitted
16/07/2007
Date registered
23/07/2007
Date last updated
17/09/2023
Date data sharing statement initially provided
17/09/2023
Date results provided
17/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A multicentre randomised phase III study of low-dose thalidomide, prednisolone and zoledronic acid versus prednisolone and zoledronic acid for post-autologous stem cell transplant (ASCT) maintenance therapy in patients with multiple myeloma (MM6)
Scientific title
A multicentre randomised phase III study of low-dose thalidomide, prednisolone and zoledronic acid versus prednisolone and zoledronic acid to assess survival post-ASCT maintenance therapy in patients with multiple myeloma
Secondary ID [1] 449 0
Australasian Leukaemia and Lymphoma Group: MM6
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 1964 0
Condition category
Condition code
Cancer 2062 2062 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multi-institutional study to assess if 12 months of 200mg daily of thalidomide added to a maintenance regimen of oral 50mg prednisolone every second day and monthly intravenous infusion of zoledronic acid will improve survival in myeloma patients post ASCT. Eligible patients will be randomised to receive thalidomide or not.
Intervention code [1] 1892 0
Treatment: Drugs
Comparator / control treatment
Prednisolone and Zoledronic acid.
Control group
Active

Outcomes
Primary outcome [1] 3145 0
To determine whether the addition of low-dose thalidomide to alternate day prednisolone and zoledronic acid maintenance therapy post-ASCT for multiple myeloma (MM) patients improves progression-free survival.
Timepoint [1] 3145 0
Time to progression is measured by monitoring patients from the time of starting maintenance therapy until a patient has progressive disease.
Secondary outcome [1] 4878 0
To determine the tolerability of low-dose thalidomide in combination with prednisolone and zoledronic acid maintenance therapy post-ASCT for MM patients
Timepoint [1] 4878 0
Measured by clinically monitoring patients on a regular basis, usually monthly, during the 12 months of receipt of thalidomide
Secondary outcome [2] 4879 0
To determine whether the addition of low-dose thalidomide to alternate day prednisolone and zoledronic acid maintenance therapy post-ASCT for MM patients improves overall survival. An improvement in overall survival would be determined by noting the difference in time to death between the thalidomide and non thalidomide arms.
Timepoint [2] 4879 0
Approximately 10-20% of myeloma patients harbour translocations involving the gene for the
fibroblast growth factor receptor-3 (FGFR3) located at 4p16 which can lead to dysregulated
expression of the gene. In view of the putative anti-angiogenic role that thalidomide may have it is
planned to prospectively determine whether any correlation exists between FGFR3 expression
levels and outcome with thalidomide maintenance therapy. This will be undertaken using a realtime PCR technique on bone marrow aspirate specimens immediately prior to ASCT and after 12
months of maintenance therapy i.e. at cessation of thalidomide in those patients randomised to
receive it.

Eligibility
Key inclusion criteria
Diagnosis of multiple myeloma responsive to standard anti-myelomatous therapy • No more than 12 months total prior standard-dose chemotherapy.• No previous high-dose chemotherapy or autologous transplantation procedure.• Eastern Cooperative Oncology Group performance status 0, 1, or 2 • Normal liver and kidney function • =2.0 x 106/kg CD34+ stem cells available for infusion.• No contraindication to the use of any of the study drugs, including known sensitivity to E coli derived preparations.• Written informed consent.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with monoclonal gammopathy of uncertain significance or indolent multiple myeloma.• Patients with progressive multiple myeloma pre or post-ASCT.• Patients whose general condition makes them unsuitable for intensive treatment • Active infections or other illnesses that would preclude conditioning chemotherapy or maintenance therapy administration or patient compliance.• Pregnant or lactating women.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient registration conducted by the Trial Centre at The Alfred Hospital. Randomization, 42-50 days post-ASCT, also by the Trial Centre and stratified by site and pre-ASCT B2 microglobulin level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomization (as above) using a computer implementation of the biased-coin method.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2002
Actual
30/05/2002
Date of last participant enrolment
Anticipated
Actual
15/03/2005
Date of last data collection
Anticipated
Actual
15/03/2006
Sample size
Target
250
Accrual to date
Final
269
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 2205 0
Commercial sector/Industry
Name [1] 2205 0
Amgen
Country [1] 2205 0
Australia
Funding source category [2] 2206 0
Commercial sector/Industry
Name [2] 2206 0
Schering Plough
Country [2] 2206 0
Australia
Funding source category [3] 2207 0
Commercial sector/Industry
Name [3] 2207 0
Pharmion
Country [3] 2207 0
United States of America
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
35 ELIZABETH STREET RICHMOND VIC 3121
Country
Australia
Secondary sponsor category [1] 1991 0
None
Name [1] 1991 0
nil
Address [1] 1991 0
Country [1] 1991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4007 0
Alfred Hospital
Ethics committee address [1] 4007 0
Ethics committee country [1] 4007 0
Australia
Date submitted for ethics approval [1] 4007 0
Approval date [1] 4007 0
01/12/2003
Ethics approval number [1] 4007 0
Ethics committee name [2] 4008 0
Auckland Hospital
Ethics committee address [2] 4008 0
Ethics committee country [2] 4008 0
New Zealand
Date submitted for ethics approval [2] 4008 0
Approval date [2] 4008 0
Ethics approval number [2] 4008 0
Ethics committee name [3] 4009 0
Austin Hospital
Ethics committee address [3] 4009 0
Ethics committee country [3] 4009 0
Australia
Date submitted for ethics approval [3] 4009 0
Approval date [3] 4009 0
Ethics approval number [3] 4009 0
Ethics committee name [4] 4010 0
Box Hill Hospital
Ethics committee address [4] 4010 0
Ethics committee country [4] 4010 0
Australia
Date submitted for ethics approval [4] 4010 0
Approval date [4] 4010 0
Ethics approval number [4] 4010 0
Ethics committee name [5] 4011 0
Canberra Hospital
Ethics committee address [5] 4011 0
Ethics committee country [5] 4011 0
Australia
Date submitted for ethics approval [5] 4011 0
Approval date [5] 4011 0
Ethics approval number [5] 4011 0
Ethics committee name [6] 4012 0
Christchurch Hospital
Ethics committee address [6] 4012 0
Ethics committee country [6] 4012 0
New Zealand
Date submitted for ethics approval [6] 4012 0
Approval date [6] 4012 0
Ethics approval number [6] 4012 0
Ethics committee name [7] 4013 0
Concord Hospital
Ethics committee address [7] 4013 0
Ethics committee country [7] 4013 0
Australia
Date submitted for ethics approval [7] 4013 0
Approval date [7] 4013 0
Ethics approval number [7] 4013 0
Ethics committee name [8] 4014 0
Dunedin Hospital
Ethics committee address [8] 4014 0
Ethics committee country [8] 4014 0
New Zealand
Date submitted for ethics approval [8] 4014 0
Approval date [8] 4014 0
Ethics approval number [8] 4014 0
Ethics committee name [9] 4015 0
Fremantle Hospital
Ethics committee address [9] 4015 0
Ethics committee country [9] 4015 0
Australia
Date submitted for ethics approval [9] 4015 0
Approval date [9] 4015 0
Ethics approval number [9] 4015 0
Ethics committee name [10] 4016 0
Geelong Hospital
Ethics committee address [10] 4016 0
Ethics committee country [10] 4016 0
Australia
Date submitted for ethics approval [10] 4016 0
Approval date [10] 4016 0
Ethics approval number [10] 4016 0
Ethics committee name [11] 4017 0
Gosford Hospital
Ethics committee address [11] 4017 0
Ethics committee country [11] 4017 0
Australia
Date submitted for ethics approval [11] 4017 0
Approval date [11] 4017 0
Ethics approval number [11] 4017 0
Ethics committee name [12] 4018 0
Royal Hobart Hospital
Ethics committee address [12] 4018 0
Ethics committee country [12] 4018 0
Australia
Date submitted for ethics approval [12] 4018 0
Approval date [12] 4018 0
Ethics approval number [12] 4018 0
Ethics committee name [13] 4019 0
Mater Hospital Brisbane
Ethics committee address [13] 4019 0
Ethics committee country [13] 4019 0
Australia
Date submitted for ethics approval [13] 4019 0
Approval date [13] 4019 0
Ethics approval number [13] 4019 0
Ethics committee name [14] 4020 0
Mater Hospital Newcastle
Ethics committee address [14] 4020 0
Ethics committee country [14] 4020 0
Australia
Date submitted for ethics approval [14] 4020 0
Approval date [14] 4020 0
Ethics approval number [14] 4020 0
Ethics committee name [15] 4021 0
Mater Private Medical Centre
Ethics committee address [15] 4021 0
Ethics committee country [15] 4021 0
Australia
Date submitted for ethics approval [15] 4021 0
Approval date [15] 4021 0
Ethics approval number [15] 4021 0
Ethics committee name [16] 4022 0
Middlemore Hospital
Ethics committee address [16] 4022 0
Ethics committee country [16] 4022 0
New Zealand
Date submitted for ethics approval [16] 4022 0
Approval date [16] 4022 0
Ethics approval number [16] 4022 0
Ethics committee name [17] 4023 0
Palmerston North Hospital
Ethics committee address [17] 4023 0
Ethics committee country [17] 4023 0
New Zealand
Date submitted for ethics approval [17] 4023 0
Approval date [17] 4023 0
Ethics approval number [17] 4023 0
Ethics committee name [18] 4024 0
Peter MacCallum Cancer Centre
Ethics committee address [18] 4024 0
Ethics committee country [18] 4024 0
Australia
Date submitted for ethics approval [18] 4024 0
Approval date [18] 4024 0
Ethics approval number [18] 4024 0
Ethics committee name [19] 4025 0
Prince of Wales Hospital
Ethics committee address [19] 4025 0
Ethics committee country [19] 4025 0
Australia
Date submitted for ethics approval [19] 4025 0
Approval date [19] 4025 0
Ethics approval number [19] 4025 0
Ethics committee name [20] 4026 0
Princess Alexandra Hospital
Ethics committee address [20] 4026 0
Ethics committee country [20] 4026 0
Australia
Date submitted for ethics approval [20] 4026 0
Approval date [20] 4026 0
Ethics approval number [20] 4026 0
Ethics committee name [21] 4027 0
Royal Adelaide Hospital
Ethics committee address [21] 4027 0
Ethics committee country [21] 4027 0
Australia
Date submitted for ethics approval [21] 4027 0
Approval date [21] 4027 0
Ethics approval number [21] 4027 0
Ethics committee name [22] 4028 0
Royal Melbourne Hospital
Ethics committee address [22] 4028 0
Ethics committee country [22] 4028 0
Australia
Date submitted for ethics approval [22] 4028 0
Approval date [22] 4028 0
Ethics approval number [22] 4028 0
Ethics committee name [23] 4029 0
Royal North Shore Hospital
Ethics committee address [23] 4029 0
Ethics committee country [23] 4029 0
Australia
Date submitted for ethics approval [23] 4029 0
Approval date [23] 4029 0
Ethics approval number [23] 4029 0
Ethics committee name [24] 4030 0
Royal Perth Hospital
Ethics committee address [24] 4030 0
Ethics committee country [24] 4030 0
Australia
Date submitted for ethics approval [24] 4030 0
Approval date [24] 4030 0
Ethics approval number [24] 4030 0
Ethics committee name [25] 4031 0
Royal Prince Alfred Hospital
Ethics committee address [25] 4031 0
Ethics committee country [25] 4031 0
Australia
Date submitted for ethics approval [25] 4031 0
Approval date [25] 4031 0
Ethics approval number [25] 4031 0
Ethics committee name [26] 4032 0
Sir Charles Gairdner Hospital
Ethics committee address [26] 4032 0
Ethics committee country [26] 4032 0
Australia
Date submitted for ethics approval [26] 4032 0
Approval date [26] 4032 0
Ethics approval number [26] 4032 0
Ethics committee name [27] 4033 0
St George Hospital
Ethics committee address [27] 4033 0
Ethics committee country [27] 4033 0
Australia
Date submitted for ethics approval [27] 4033 0
Approval date [27] 4033 0
Ethics approval number [27] 4033 0
Ethics committee name [28] 4034 0
St Vincent’s Hospital Melbourne
Ethics committee address [28] 4034 0
Ethics committee country [28] 4034 0
Australia
Date submitted for ethics approval [28] 4034 0
Approval date [28] 4034 0
Ethics approval number [28] 4034 0
Ethics committee name [29] 4035 0
St Vincent’s Hospital Sydney
Ethics committee address [29] 4035 0
Ethics committee country [29] 4035 0
Australia
Date submitted for ethics approval [29] 4035 0
Approval date [29] 4035 0
Ethics approval number [29] 4035 0
Ethics committee name [30] 4036 0
Townsville Hospital
Ethics committee address [30] 4036 0
Ethics committee country [30] 4036 0
Australia
Date submitted for ethics approval [30] 4036 0
Approval date [30] 4036 0
Ethics approval number [30] 4036 0
Ethics committee name [31] 4037 0
Waikato Hospital
Ethics committee address [31] 4037 0
Ethics committee country [31] 4037 0
New Zealand
Date submitted for ethics approval [31] 4037 0
Approval date [31] 4037 0
Ethics approval number [31] 4037 0
Ethics committee name [32] 4038 0
Wellington Hospital
Ethics committee address [32] 4038 0
Ethics committee country [32] 4038 0
New Zealand
Date submitted for ethics approval [32] 4038 0
Approval date [32] 4038 0
Ethics approval number [32] 4038 0
Ethics committee name [33] 4039 0
Westmead Hospital
Ethics committee address [33] 4039 0
Ethics committee country [33] 4039 0
Australia
Date submitted for ethics approval [33] 4039 0
Approval date [33] 4039 0
Ethics approval number [33] 4039 0
Ethics committee name [34] 4040 0
Wollongong Hospital
Ethics committee address [34] 4040 0
Ethics committee country [34] 4040 0
Australia
Date submitted for ethics approval [34] 4040 0
Approval date [34] 4040 0
Ethics approval number [34] 4040 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27706 0
Address 27706 0
Country 27706 0
Phone 27706 0
Fax 27706 0
Email 27706 0
Contact person for public queries
Name 11081 0
Associate Professor Andrew Spencer
Address 11081 0
Myeloma Research Group
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 11081 0
Australia
Phone 11081 0
61 3 9076 3392
Fax 11081 0
61 3 9076 2298
Email 11081 0
[email protected]
Contact person for scientific queries
Name 2009 0
Associate Professor Andrew Spencer
Address 2009 0
Myeloma Research Group
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 2009 0
Australia
Phone 2009 0
61 3 9076 3392
Fax 2009 0
61 3 9076 2298
Email 2009 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD data for all data collected during the trial
When will data be available (start and end dates)?
Data available 3 months following publication, for an indefinite period
Available to whom?
Data are potentially available to:
• Researchers from not-for-profit organisations
• Commercial organisations
• Other
Based in:
• Any location
Further information:
All data requests will be considered by the sponsor ALLG on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Available for what types of analyses?
Any type of analysis. Proposals will be assessed on a case-by-case basis
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20365Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]



Results publications and other study-related documents

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