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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Multiple Myeloma

Treatments: Drug: Prednisone; Drug: Bortezomib; Drug: Melphalan

Study type: Observational

Funder types: Industry

Identifiers

NCT02474563

26866138MMY4056 (Other Identifier)

CR018445

Details and patient eligibility

About

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

Full description

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.

Enrollment: 171 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

171 participants in 1 patient group

Bortezomib, Melphalan, Prednisone (VMP) Group

Description:

Participants will not receive any intervention in this study. Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.

Treatment:

Drug: Prednisone

Drug: Bortezomib

Drug: Melphalan