Status:
COMPLETED
A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma
Lead Sponsor:
Janssen-Cilag Pty Ltd
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
This is an open-label, single-arm, multicentre study which will enroll approximately 105 patients. Open-label means all people involved in the study know the identity of the intervention. Single-arm m...
Eligibility Criteria
Inclusion
- Previously diagnosed with multiple myeloma
- eligible for autologous stem cell transplantation
- meets pre-treatment lab criteria (as defined within protocol).
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00872521
Start Date
January 1 2009
End Date
November 1 2011
Last Update
May 16 2014
Active Locations (16)
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1
Adelaide, Australia
2
Box Hill, Australia
3
Brisbane, Australia
4
Camperdown, Australia