A Study of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed Multiple Myeloma Previously Treated With Bortezomib

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Jun 26, 2008

Keywords

ClinConnect Summary

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 is defined as the proportion of patients achieving either a complete response (CR) or partial response (PR) to treatment according to the European Group for Blood and Marrow Transplantation (EBMT) criteria. This is a single arm (all patients will receive the same drug combination and dose), multi-center (many study sites), open label (the patient and the physician know the drug treatment being ...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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