Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the 2-year progression-free survival rate.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Bortezomib; Melphalan; Prednisone

Criteria

Inclusion Criteria:

• Participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation

• Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal plasma cells greater than or equal to (>=) 10% or histologically confirmed plasmacytoma; b) Presence of monoclonal protein in the serum or urine; c) Myeloma-related organ impairment as defined in protocol

• Participants with presence of an illness that is detectable by definitions as defined in protocol

• Postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial

Exclusion Criteria:

• Participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone < 160mg in total)

• Participants with severe peripheral neuropathy (Grade >= 2 by NCI CTC version 4.0)

• Pregnant or breastfeeding mothers

• Participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial

• Participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)