A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma
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
3 other identifiers
interventional
107
1 country
16
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Jan 2009
Shorter than P25 for phase_2 multiple-myeloma
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
May 7, 2013
CompletedMay 16, 2014
May 1, 2014
2.2 years
March 27, 2009
December 14, 2012
May 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
84 days
Secondary Outcomes (14)
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
84 days
Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).
3-months following ASCT
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
3-months after ASCT
Event Free Survival (EFS)
2 years after Day 1 Cycle 1 of PAD
Overall Survival
2 years after Day 1 Cycle 1 of PAD
- +9 more secondary outcomes
Study Arms (1)
bortezomib; doxorubicin; dexamethasone
EXPERIMENTALPAD 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)
Interventions
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)
Eligibility Criteria
You may qualify if:
- Previously diagnosed with multiple myeloma
- eligible for autologous stem cell transplantation
- meets pre-treatment lab criteria (as defined within protocol).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Adelaide, Australia
Unknown Facility
Box Hill, Australia
Unknown Facility
Brisbane, Australia
Unknown Facility
Camperdown, Australia
Unknown Facility
Geelong, Australia
Unknown Facility
Gosford, Australia
Unknown Facility
Greenslopes, Australia
Unknown Facility
Malvern, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
Parkville, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Sydney, Australia
Unknown Facility
Westmead, Australia
Unknown Facility
Woden, Australia
Unknown Facility
Wollongong, Australia
Unknown Facility
Woolloongabba, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Regional Medical Affairs Director Asia Pacific
- Organization
- Jan-Cil Australia
Study Officials
- STUDY DIRECTOR
Janssen-Cilag Pty Ltd Clinical Trial
Janssen-Cilag Pty Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2009
First Posted
March 31, 2009
Study Start
January 1, 2009
Primary Completion
March 1, 2011
Study Completion
November 1, 2011
Last Updated
May 16, 2014
Results First Posted
May 7, 2013
Record last verified: 2014-05