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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474563
• Other study ID #: CR018445
• Secondary ID: 26866138MMY4056
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2015
• Last updated: June 26, 2015
• Start date: May 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib
Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.
• Melphalan
Participants receiving Melphalan 9 mg/m^2 will be observed in this study.
• Prednisone
Participants receiving Prednisone 60 mg/m^2 will be observed in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year Progression-free Survival Rate	Progression-free survival rate: the length of time from the day when Bortezomib was first administered to disease progression or death, whichever comes first, in 2 years.	Up to 2 years	No
Secondary	Time to Response	Time from the first day of Bortezomib administration to the day of confirmed first response in participants with confirmed response, or to the day of loss to follow-up, disease progression, death or completion of study therapy in participants without response.	up to 2 years	No
Secondary	Overall Response Rate	Percentage of participants who achieved CR, VGPR or PR in 2 years.	up to 2 years	No
Secondary	Complete Response Rate	Percentage of participants who achieved CR as best response.	up to 2 years	No
Secondary	Time to Next therapy	The next therapy after the end of the study therapy was investigated, and the time from the day when the first therapy was started to the day when the next therapy was started was calculated.	up to 2 years	No
Secondary	Time to Disease Progression	Time from the first day of Bortezomib administration to the day of disease progression or relapse from complete response, whichever comes first.	up to 2 years	No

External Links

•   To learn how to participate in this trial please click here.