Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000296235
Ethics application status
Approved
Date submitted
27/03/2009
Date registered
18/05/2009
Date last updated
12/11/2021
Date data sharing statement initially provided
12/11/2021
Date results information initially provided
12/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II trial of PAD (Bortezomib, Doxorubicin and Dexamethasone) induction therapy in transplant-eligible patients with untreated multiple myeloma (MM), stratified for markers of bortezomib resistance.
Scientific title
A phase II trial of PAD (Bortezomib, Doxorubicin and Dexamethasone) induction therapy in transplant-eligible patients with untreated multiple myeloma (MM), stratified for markers of bortezomib resistance, comparing overall response rate to PAD (Bortezomib, Doxorubicin and Dexamethasone).
Universal Trial Number (UTN)
Trial acronym
The PIMMS Trial: The PAD Induction in Multiple Myeloma Stratified Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 4531 0
Condition category
Condition code
Cancer 4819 4819 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four 21-day cycles of PAD: a combination of bortezomib i.v. (intravenous) 1.3mg/m2 (Days 1,4, 8 and 11), doxorubicin i.v. 20mg/m2 (days 1 and 4) and dexamethasone p.o. (by mouth) (days 1, 2, 4, 5, 8, 9, 11 and 12).
Days 13 to 21 will be 'rest' days - i.e. no treatment will be given on these days.
Intervention code [1] 4290 0
Treatment: Drugs
Comparator / control treatment
N/A - Open label study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5679 0
To compare the overall response rate following 4 cycles of PAD induction therapy between patients with and without amplification of 1q21 (measured by FISH - Fluorescence In Situ Hybridization ) in their marrow at baseline. Overall response will be measured by a number of factors including M-protein changes, clinical examination, radiological images, bone marrow results and IMWG (International Myeloma Working Group) Uniform Disease Response Criteria.
Timepoint [1] 5679 0
Disease response assessed monthly for 1 year after first treatment.
Secondary outcome [1] 241853 0
To compare the overall response rate to PAD induction therapy 3-months following ASCT (Autologous Stem Cell Transplantation), between patients with and without amplification of 1q21
Timepoint [1] 241853 0
3-months following ASCT.
Secondary outcome [2] 241854 0
To determine the event-free survival and overall survival rate at 2 years after Day 1 Cycle 1 of PAD.
Timepoint [2] 241854 0
2 years after Day 1 Cycle 1 of PAD
Secondary outcome [3] 241855 0
To determine the effect on overall response rate and overall survival of protein expression of p53, p16, Cyclin D1, bcl2, FGFR3 (Fibroblast growth factor receptor 3) (measured by immunohistochemistry)
Timepoint [3] 241855 0
At PAD completion and 3-months following ASCT.
Secondary outcome [4] 241856 0
To assess quality of life of patients treated with PAD
Timepoint [4] 241856 0
At each study visit. There are a total of 15 study visits, performed at: Screening, Day 1 of each Cycle, PBSC (Peripheral Blood Stem Cell) Collection and ASCT visits; then at monthly intervals to 1 year after first treatment; and finally at 2 years after first treatment.

Eligibility
Key inclusion criteria
Previously diagnosed with multiple myeloma; eligible for autologous stem cell transplantation; meets pre-treatment lab criteria (as defined within protocol).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously received treatment for multiple myeloma (including prior therapy with radiation or pulsed dexamethasone), except localised radiation to a solitary lesion or plasmacytomas or 4 days of corticosteroid therapy; have a current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), or Waldenstrom Macroglobulinemia; have a history of any other malignancy within 5 years before enrolment; have other significant comorbidities

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
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/01/2009
Actual
23/01/2009
Date of last participant enrolment
Anticipated
Actual
27/11/2009
Date of last data collection
Anticipated
Actual
25/11/2011
Sample size
Target
105
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4721 0
Commercial sector/Industry
Name [1] 4721 0
Janssen-Cilag Pty Ltd
Country [1] 4721 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag Pty Ltd
Address
1 - 5 Khartoum Road
North Ryde
NSW 2113
Country
Australia
Secondary sponsor category [1] 4266 0
None
Name [1] 4266 0
Address [1] 4266 0
Country [1] 4266 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6758 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 6758 0
Level 3, Hanson Institute, North Terrace, Adelaide, SA 5000
Ethics committee country [1] 6758 0
Australia
Date submitted for ethics approval [1] 6758 0
17/09/2008
Approval date [1] 6758 0
07/11/2008
Ethics approval number [1] 6758 0
081021
Ethics committee name [2] 6759 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [2] 6759 0
Hospital Avenue, Nedlands, WA 6009
Ethics committee country [2] 6759 0
Australia
Date submitted for ethics approval [2] 6759 0
01/12/2008
Approval date [2] 6759 0
04/02/2009
Ethics approval number [2] 6759 0
2008-110
Ethics committee name [3] 6760 0
Ethics Review Committee (Royal Prince Alfred Hospital Zone) - Central Site for NSW
Ethics committee address [3] 6760 0
Research Development Building
Level 3, Building 92, Royal Pronce Alfred Hospital, Camperdown, NSW 2050
Ethics committee country [3] 6760 0
Australia
Date submitted for ethics approval [3] 6760 0
09/09/2008
Approval date [3] 6760 0
02/10/2008
Ethics approval number [3] 6760 0
08/RPAH/403
Ethics committee name [4] 6761 0
Bellberry Human Research Ethics Committee
Ethics committee address [4] 6761 0
First Floor 71 Anzac Highway, Ashford South, SA 5035
Ethics committee country [4] 6761 0
Australia
Date submitted for ethics approval [4] 6761 0
09/12/2008
Approval date [4] 6761 0
08/01/2009
Ethics approval number [4] 6761 0
A171/08
Ethics committee name [5] 6762 0
Greenslopes Private Hospital Ethics Committee
Ethics committee address [5] 6762 0
Newdegate Street, Greenslopes, QLD 4120
Ethics committee country [5] 6762 0
Australia
Date submitted for ethics approval [5] 6762 0
31/10/2008
Approval date [5] 6762 0
10/12/2008
Ethics approval number [5] 6762 0
08/32
Ethics committee name [6] 6763 0
Cabrini Human Research Ethics Committee
Ethics committee address [6] 6763 0
183 Wattletree Road, Malvern, VIC 3144
Ethics committee country [6] 6763 0
Australia
Date submitted for ethics approval [6] 6763 0
11/09/2008
Approval date [6] 6763 0
10/12/2008
Ethics approval number [6] 6763 0
05-29-09-08
Ethics committee name [7] 6764 0
Barwon Health Human Research Ethics Committee
Ethics committee address [7] 6764 0
The Geelong Hospital, Ryrie Street, P.O. Box 281, Geelong, VIC 3220
Ethics committee country [7] 6764 0
Australia
Date submitted for ethics approval [7] 6764 0
10/12/2008
Approval date [7] 6764 0
21/01/2009
Ethics approval number [7] 6764 0
08/92

Summary
Brief summary
The purpose of this study is to determine efficacy of treatment with bortezomib (in combination with doxorubicin and dexamethasone) in previously untreated patients with Multiple Myeloma
Trial website
Trial related presentations / publications
Data is added in Step 11 (Data sharing statement) and Step 12 (Summary results) instead.
Public notes

Contacts
Principal investigator
Name 29439 0
Address 29439 0
Country 29439 0
Phone 29439 0
Fax 29439 0
Email 29439 0
Contact person for public queries
Name 12686 0
Ellie Ashurst
Address 12686 0
Janssen-Cilag Pty Ltd
1 - 5 Khartoum Road
North Ryde
NSW 2113
Country 12686 0
Australia
Phone 12686 0
+61 2 9815 3485
Fax 12686 0
Email 12686 0
[email protected]
Contact person for scientific queries
Name 3614 0
Ellie Ashurst
Address 3614 0
Janssen-Cilag Pty Ltd
1 - 5 Khartoum Road
North Ryde
NSW 2113
Country 3614 0
Australia
Phone 3614 0
+61 2 9815 3485
Fax 3614 0
Email 3614 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?
All data.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
No end date determined.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Available to whom?
Researchers.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Available for what types of analyses?
Any analysis in expected research proposal.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
How or where can data be obtained?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
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