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

June 26, 2015 updated by: Janssen Korea, Ltd., Korea

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

171

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Anyang, Korea, Republic of
      • Busan, Korea, Republic of
      • Cheonan, Korea, Republic of
      • Cheonan City, Korea, Republic of
      • Chungcheongbuk-Do, Korea, Republic of
      • Dae-Gu, Korea, Republic of
      • Daegu, Korea, Republic of
      • Daejeon, Korea, Republic of
      • Daejon, Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
      • Hwasun Gun, Korea, Republic of
      • Iksan, Korea, Republic of
      • Incheon, Korea, Republic of
      • Jeonju-Si, Korea, Republic of
      • Jinju-Si, Korea, Republic of
      • Pucheon, Korea, Republic of
      • Pusan, Korea, Republic of
      • Seongnam, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
      • Ulsan, Korea, Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.
Participants receiving Melphalan 9 mg/m^2 will be observed in this study.
Participants receiving Prednisone 60 mg/m^2 will be observed in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year Progression-free Survival Rate
Time Frame: Up to 2 years
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Response
Time Frame: up to 2 years
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
Overall Response Rate
Time Frame: up to 2 years
Percentage of participants who achieved CR, VGPR or PR in 2 years.
up to 2 years
Complete Response Rate
Time Frame: up to 2 years
Percentage of participants who achieved CR as best response.
up to 2 years
Time to Next therapy
Time Frame: up to 2 years
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
Time to Disease Progression
Time Frame: up to 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 17, 2015

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Bortezomib

3
Subscribe