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

• Status: Withdrawn
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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 previously treated with bortezomib. Multiple myeloma is a cancer that begins in plasma cells, a type of white blood cell. These cells are part of the immune system, which helps protect the body from germs and other harmful substances. In time, myeloma cells collect in the bone marrow and in the solid parts of bone. Multiple myeloma treatment may include stem cell transplantation, however, not all patients with multiple myeloma are candidates for stem cell transplantation and many patients who receive transplants relapse. As a result, additional first and later-line therapeutic options are needed for patients who are not candidates for transplantation, or whose disease relapses after transplantation or other therapies. Pegylated liposomal doxorubicin in combination with bortezomib is approved for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. The combined use of pegylated liposomal doxorubicin and bortezomib in this study is designed to evaluate the overall response rate and safety in patients with multiple myeloma who have been previously treated with bortezomib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Centocor Ortho Biotech Services, L.L.C.
• Treatments: Bortezomib; Doxorubicin; Liposomal doxorubicin

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