Status:
WITHDRAWN
A Study of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed Multiple Myeloma Previously Treated With Bortezomib
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Centocor Ortho Biotech Services, L.L.C.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of using pegylated liposomal doxorubicin and bortezomib in the treatment of patients with relapsed multiple myeloma who had been p...
Detailed Description
The primary purpose of this study is to evaluate the overall response rate to DOXIL/VELCADE treatment in patients with relapsed multiple myeloma previously treated with VELCADE. Overall response rate ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Multiple Myeloma
- Received prior courses of bortezomib (VELCADE)-based therapy
- Greater than or equal to 50% reduction in M-Protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of VELCADE-based therapy
- 60 days or more since the patient's last VELCADE dose
- Life expectancy \> 3 months
- Progressive disease defined by new or worsening lytic bone lesions or plasmacytoma or hypercalcemia or a \>25% increase in M-protein
Exclusion
- No patients with progressive disease while receiving an anthracycline-based regimen
- No patients with \>2 prior regimens for the treatment of multiple myeloma
- No major surgery within 2 weeks before screening
- No patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent
- No patients known to be human immunodeficiency virus (HIV) positive
- No patients with poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness
- No patients with an active systemic infection requiring treatment
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00706953
Start Date
July 1 2008
End Date
June 1 2010
Last Update
April 6 2015
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