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Trial registered on ANZCTR


Registration number
ACTRN12605000770662
Ethics application status
Approved
Date submitted
29/11/2005
Date registered
30/11/2005
Date last updated
22/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study to explore the tolerability and efficacy of bortezomib as part of induction and post-transplant therapy in multiple myeloma
Scientific title
A pilot study to explore the tolerability and efficacy of bortezomib as part of induction and post-transplant therapy in multiple myeloma
Secondary ID [1] 281571 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
BIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 926 0
Condition category
Condition code
Cancer 994 994 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Induction cycle (1) Vincristine, Doxorubicin and Dexamethasone (VAD).
Good responders will continue with two more cycles of VAD.
Poor responders will have two cycles of bortezomib, Doxorubicin and Dexamethasone (VcAD).
Patient will proceed to peripheral blood stem cell mobilisation and transplant.
Patients who are not in remission after transplant will receive 2 cycles of single agent bortezomib treatment.
All patients will receive prednisolone maintenance for one year post transplant.
Intervention code [1] 776 0
Treatment: Drugs
Comparator / control treatment
historic control
Control group
Historical

Outcomes
Primary outcome [1] 1322 0
1. To examine the tolerability of bortezomib and its ability to increase the CCR rate when used as part of induction therapy in patients with newly diagnosed multiple myeloma, who have a <50% response to the first cycle of VAD chemotherapy and by virtue of the poor initial response are thought to have a poor prognosis.
Timepoint [1] 1322 0
at the end of 3 induction cycles
Primary outcome [2] 1323 0
2. To examine the tolerability and efficacy of bortezomib to induce CCR in patients who are not in CCR following high dose therapy (HDT) and peripheral blood stem cell transplantation (PBSCT).
Timepoint [2] 1323 0
at the end of 2 re-induction cycles
Primary outcome [3] 1324 0
3. To examine the feasibility of harvesting sufficient PBSC for two autologous PBSCT, ie 6 x 106 CD34+ cells/kg BW, following high dose cyclophosphamide and G-CSF in patient whose induction therapy included bortezomib.
Timepoint [3] 1324 0
on completion of stem cell mobilisation and harvest
Secondary outcome [1] 2363 0
1. To compare the response of initial poor responders treated with bortezomib with a historical group of patients treated with standard chemotherapy and with those in this study who had initially good response to VAD and completed VAD induction.
Timepoint [1] 2363 0
At the end of 3 induction cycles
Secondary outcome [2] 2364 0
2. To examine the overall survival (OS) and event free survival (EFS) of patients treated with bortezomib as part of pre-transplant induction, as post-tansplant reinduction, or during both phases of therapy compared with a historical group of patients treated with standard chemotherapy (VAD/Cyclophosphamide/melphalan200 PBSCT) and with reports in the literature of patients treated with tandem HDT and PBSCT.
Timepoint [2] 2364 0
36 months post transplant
Secondary outcome [3] 2365 0
3. To examine OS and EFS within the study population of patients who did or did not receive bortezomib.
Timepoint [3] 2365 0
36 months post transplant
Secondary outcome [4] 2366 0
4. To examine engraftment kinetics of PBSC harvested after bortezomib therapy.
Timepoint [4] 2366 0
post transplant
Secondary outcome [5] 2367 0
5. To assess the difference in outcomes between patients treated with or without bortezomib to enable an estimate of the sample size that may be required for a randomised study with a similar structure.
Timepoint [5] 2367 0
36 months post transplant

Eligibility
Key inclusion criteria
Previously untreated, advanced multiple myeloma, planned for autologous PBSCT, absence of significant co-morbidity.
Minimum age
Not stated
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Other
Other design features
response-adapted
Phase
Phase 2
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
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 1091 0
Commercial sector/Industry
Name [1] 1091 0
Janssen-Cilag Pty Limited
Address [1] 1091 0
1-5 Khartoum Road, North Ryde NSW 2113
Country [1] 1091 0
Australia
Primary sponsor type
Hospital
Name
Clinical Haematology & Bone Marrow Transplant Unit, Royal Adelaide Hospital
Address
North Terrace, SA 5000, Australia
Country
Australia
Secondary sponsor category [1] 952 0
None
Name [1] 952 0
None
Address [1] 952 0
Country [1] 952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2395 0
Royal Adelaide Hospital
Ethics committee address [1] 2395 0
Adelaide, South Australia
Ethics committee country [1] 2395 0
Australia
Date submitted for ethics approval [1] 2395 0
Approval date [1] 2395 0
Ethics approval number [1] 2395 0
Ethics committee name [2] 2396 0
Roayl Brisbane & Women's Hospital & Health Service Districts
Ethics committee address [2] 2396 0
Ethics committee country [2] 2396 0
Australia
Date submitted for ethics approval [2] 2396 0
Approval date [2] 2396 0
Ethics approval number [2] 2396 0

Summary
Brief summary
This study is for patients who have newly diagnosed myeloma to check how effective and safe is velcade.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35865 0
Address 35865 0
Country 35865 0
Phone 35865 0
Fax 35865 0
Email 35865 0
Contact person for public queries
Name 9965 0
Che TO
Address 9965 0
Haematology Clinical Trial Office
Royal Adelaide Hospital
Level 3
East Wing
Adelaide SA 5000
Country 9965 0
Australia
Phone 9965 0
+61 8 82222920
Fax 9965 0
+61 8 82223375
Email 9965 0
cto@mail.rah.sa.gov.au
Contact person for scientific queries
Name 893 0
Dr Noemi Horvath
Address 893 0
Division of Haematology
Hanson Institute
Institute of Medical and Vetinary Science (IMVS)
Frome Road
Adelaide SA 5000
Country 893 0
Australia
Phone 893 0
+61 8 82223328
Fax 893 0
Email 893 0
noemi.horvath@imvs.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary