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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00872521




Registration number
NCT00872521
Ethics application status
Date submitted
27/03/2009
Date registered
31/03/2009
Date last updated
16/05/2014

Titles & IDs
Public title
A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma
Scientific title
A Phase II Trial of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction Therapy in Patients With Untreated Multiple Myeloma (MM), Stratified for Markers of Bortezomib Resistance
Secondary ID [1] 0 0
26866138MMY2059
Secondary ID [2] 0 0
CR015640
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PAD induction

Experimental: bortezomib; doxorubicin; dexamethasone - PAD induction Open Label Treatment: Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1 4 8 \& 11) Doxorubicin 20 mg/m2 i.v. (D1 \& 4) Dexamethasone 20 mg p.o. (D1 2 4 5 8 9 11 \& 12)


Treatment: Drugs: PAD induction
Open Label Treatment:

Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1, 4, 8 \& 11), Doxorubicin 20 mg/m2 i.v. (D1 \& 4), Dexamethasone 20 mg p.o. (D1, 2, 4, 5, 8 , 9, 11 \& 12)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Assessment method [1] 0 0
International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; PR: =50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by =90% or \<200 mg/24hour
Timepoint [1] 0 0
84 days
Secondary outcome [1] 0 0
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Assessment method [1] 0 0
Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD).
Timepoint [1] 0 0
84 days
Secondary outcome [2] 0 0
Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).
Assessment method [2] 0 0
Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction.
Timepoint [2] 0 0
3-months following ASCT
Secondary outcome [3] 0 0
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
Assessment method [3] 0 0
Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.
Timepoint [3] 0 0
3-months after ASCT
Secondary outcome [4] 0 0
Event Free Survival (EFS)
Assessment method [4] 0 0
Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
Timepoint [4] 0 0
2 years after Day 1 Cycle 1 of PAD
Secondary outcome [5] 0 0
Overall Survival
Assessment method [5] 0 0
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
Timepoint [5] 0 0
2 years after Day 1 Cycle 1 of PAD
Secondary outcome [6] 0 0
Assessment of Quality of Life (AQoL) Scores
Assessment method [6] 0 0
The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
Overall Response Rate (ORR) Stratified by Protein Expression (p53)
Assessment method [7] 0 0
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).
Timepoint [7] 0 0
84 days
Secondary outcome [8] 0 0
Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).
Assessment method [8] 0 0
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1).
Timepoint [8] 0 0
84 days
Secondary outcome [9] 0 0
Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)
Assessment method [9] 0 0
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2)
Timepoint [9] 0 0
84 days
Secondary outcome [10] 0 0
Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)
Assessment method [10] 0 0
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3)
Timepoint [10] 0 0
84 days
Secondary outcome [11] 0 0
Overall Survival (OS) Stratified by Protein Expression (p53).
Assessment method [11] 0 0
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53).
Timepoint [11] 0 0
2 years after Day 1 Cycle 1 of PAD
Secondary outcome [12] 0 0
Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)
Assessment method [12] 0 0
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1).
Timepoint [12] 0 0
2 years after Day 1 Cycle 1 of PAD
Secondary outcome [13] 0 0
Overall Survival (OS) Stratified by Protein Expression (Bcl-2)
Assessment method [13] 0 0
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (bcl-2).
Timepoint [13] 0 0
2 years after Day 1 Cycle 1 of PAD
Secondary outcome [14] 0 0
Overall Survival (OS) Stratified by Protein Expression (FGFR3)
Assessment method [14] 0 0
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (FGFR3).
Timepoint [14] 0 0
2 years after Day 1 Cycle 1 of PAD

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 Waldenström 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
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Camperdown
Recruitment hospital [5] 0 0
- Geelong
Recruitment hospital [6] 0 0
- Gosford
Recruitment hospital [7] 0 0
- Greenslopes
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Melbourne
Recruitment hospital [10] 0 0
- Parkville
Recruitment hospital [11] 0 0
- Perth
Recruitment hospital [12] 0 0
- Sydney
Recruitment hospital [13] 0 0
- Westmead
Recruitment hospital [14] 0 0
- Woden
Recruitment hospital [15] 0 0
- Wollongong
Recruitment hospital [16] 0 0
- Woolloongabba N/A
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Camperdown
Recruitment postcode(s) [5] 0 0
- Geelong
Recruitment postcode(s) [6] 0 0
- Gosford
Recruitment postcode(s) [7] 0 0
- Greenslopes
Recruitment postcode(s) [8] 0 0
- Malvern
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Parkville
Recruitment postcode(s) [11] 0 0
- Perth
Recruitment postcode(s) [12] 0 0
- Sydney
Recruitment postcode(s) [13] 0 0
- Westmead
Recruitment postcode(s) [14] 0 0
- Woden
Recruitment postcode(s) [15] 0 0
- Wollongong
Recruitment postcode(s) [16] 0 0
- Woolloongabba N/A

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag Pty Ltd
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag Pty Ltd Clinical Trial
Address 0 0
Janssen-Cilag Pty Ltd
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00872521