AzTrials
AzTrials

Multiple MyelomaNCT02474563

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

An observational study of Multiple Myeloma, run by Janssen Korea, Ltd., Korea at 18 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 20 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Bortezomib, Melphalan and Prednisone
How many people
171 participants
Where
18 sitesSouth Korea
Study dates
May 2011to May 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

18 sites in 1 country.

18 sites in 1 country

South Korea18 sites

  • Study site

    Anyang

  • Study site

    Busan

  • Study site

    Cheonan

  • Study site

    Chungcheongbuk-Do

  • Study site

    Daegu

  • Study site

    Daejeon

  • Study site

    Gyeonggi-do

  • Study site

    Hwasun Gun

  • Study site

    Iksan

  • Study site

    Incheon

  • Study site

    Jeonju

  • Study site

    Jinju

  • Study site

    Pucheon

  • Study site

    Pusan

  • Study site

    Seongnam

  • Study site

    Seoul

  • Study site

    Suwon

  • Study site

    Ulsan

Other trials in South Korea

About this study

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

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

Read the 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.

Keywords
Multiple Myeloma, Bortezomib, Melphalan, Prednisone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

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

  • MelphalanDrug

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

  • PrednisoneDrug

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

Study groups in NCT02474563
Study groupRoleWhat they receive
Bortezomib, Melphalan, Prednisone (VMP) GroupParticipants 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.
Receives: Drug: Bortezomib; Drug: Melphalan; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. 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.

    Measured: up to 2 years

  2. Overall Response Rate

    Percentage of participants who achieved CR, VGPR or PR in 2 years.

    Measured: up to 2 years

  3. Complete Response Rate

    Percentage of participants who achieved CR as best response.

    Measured: up to 2 years

  4. 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.

    Measured: up to 2 years

  5. 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.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2015 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02474563
Sponsor's protocol ID
CR018445
Other IDs
26866138MMY4056
Status last verified
Jun 2015
First submitted
15 Jun 2015
Last updated
30 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Janssen Korea, Ltd., Korea at 18 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Progression-free Survival Rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02474563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in