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

NCT ID: NCT02474563

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Multiple Myeloma

Keywords

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Multiple Myeloma Bortezomib Melphalan Prednisone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bortezomib, Melphalan, Prednisone (VMP) Group

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.

Bortezomib

Intervention Type DRUG

Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.

Melphalan

Intervention Type DRUG

Participants receiving Melphalan 9 mg/m\^2 will be observed in this study.

Prednisone

Intervention Type DRUG

Participants receiving Prednisone 60 mg/m\^2 will be observed in this study.

Interventions

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Bortezomib

Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.

Intervention Type DRUG

Melphalan

Participants receiving Melphalan 9 mg/m\^2 will be observed in this study.

Intervention Type DRUG

Prednisone

Participants receiving Prednisone 60 mg/m\^2 will be observed in this study.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

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Anyang, , South Korea

Site Status

Busan, , South Korea

Site Status

Cheonan, , South Korea

Site Status

Chungcheongbuk-Do, , South Korea

Site Status

Daegu, , South Korea

Site Status

Daejeon, , South Korea

Site Status

Gyeonggi-do, , South Korea

Site Status

Hwasun Gun, , South Korea

Site Status

Iksan, , South Korea

Site Status

Incheon, , South Korea

Site Status

Jeonju, , South Korea

Site Status

Jinju, , South Korea

Site Status

Pucheon, , South Korea

Site Status

Pusan, , South Korea

Site Status

Seongnam, , South Korea

Site Status

Seoul, , South Korea

Site Status

Suwon, , South Korea

Site Status

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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26866138MMY4056

Identifier Type: OTHER

Identifier Source: secondary_id

CR018445

Identifier Type: -

Identifier Source: org_study_id