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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00872521
Ethics application status
Date submitted
27/03/2009
Date registered
27/03/2009
Date last updated
7/05/2014

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 - 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 - 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). - 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) - 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) - 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 - 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 - 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) - 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). - 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) - 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) - 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). - 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) - 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) - 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) - 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
Gender
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
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
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)
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
Address
Country

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/show/NCT00872521
Trial related presentations / publications
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications