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

A Prospective, Open-label, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone(VMP) for Initial Treatment in Patients With Multiple Myeloma Who do Not Undergo Autologous Stem Cell Transplantation

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

This was a prospective, open-label, multicenter, observational study. Participants who received bortezomib, Melphalan, Prednisone(VMP) therapy for Multiple myeloma (MM) that was not eligible for autologous stem cell transplantation will be enrolled in the study. The study will consist of Screening phase; VMP therapy phase (9cycles); Follow-up phase (2 years from the day when the first cycle was started). Participants visited each institution for evaluation for 2 years from the date of baseline evaluation and first VMP administration (duration of treatment, 9 cycles; follow-up visits, every 3 months after the end of the treatment). Participants receiving VMP therapy will be primarily evaluated for 2-year progression-free survival rate. Participants safety will be monitored throughout the study.

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)