Multiple MyelomaVISIONNCT04151615
VMP Regimen - Safety, Efficacy, and Optimal Dose Finding Study for Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Boryung Pharmaceutical Co., Ltd at 24 sites in South Korea.
Trial summary
The 3-drug therapy of Bortezomib-Melphalan-Prednisolone (VMP) is a standard therapy that is commonly used currently in South Korea as a first-line treatment for treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 203 participants
- Where
- 24 sitesSouth Korea
- Study dates
- 15 Nov 2018to 11 Jan 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation
Who may be able to join
- Patients who provide written consent on the informed consent form for use of personal information after listening to an explanation regarding the purpose, method, etc., of this clinical study
- Adult males and females aged 19 years or above
- Patients without previous experience of treatment for multiple myeloma who have been evaluated as ineligible for hematopoietic transplantation
- Patients scheduled to receive the 3-drug combination (VMP therapy) treatment
- Patients with expected survival period of 6 months or more
- Patients evaluated as having performance status score (ECOG PS) ≤2 (score of 0, 1, 2)
Show all 11Show fewer
- Patients who have received the following tests within 6 months prior to enrollment
- Beta2-microglobulin
- Serum albumin
- Serum LDH
- Patients with confirmed del (17), t (4;14), t (14;16) by hybridization FISH test
Who cannot join
- Patients who have been newly diagnosed with other primary cancers within the last 5 years that can affect the treatment or prognosis of multiple myeloma
- Pregnant women and breast-feeding women
- Patients who are currently participating in other clinical studies (drug or medical device clinical studies) or planning to participate in other clinical studies during the study participation period
- Patients who are determined ineligible to participate in the study by other judgments of the investigator
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
South Korea24 sites
Soonchunhyang University Bucheon hospital
Bucheon-si
Inje university Haeundae Paik Hospital
Busan
Kosin University Gospel hospital
Busan
Pusan national University Hospital
Busan
Keimyung University Hospital(Dongsan Medical Center)
Daegu
Yeungnam University Medical Center
Daegu
Chungnam National University Hospital
Daejeon
National Cancer Center
Goyang
Gyeongsang National University Changwon Hospital
Gyeongsang
Chonnam National University Hwasun Hospital
Hwasun
Gachon University Gil Medical Center
Incheon
Chungbuk national university Hospital
Jungbuk
Dankook University Hospital
Jungnam
Chung-Ang University Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Soonchunhyang University Hospital
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
Ajou University Medical Center
Suwon
Ulsan University hospital
Ulsan
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: A Multi-center,Open, Longitudinal, Observational Study to Evaluate the Treatment Effectiveness and Safety of the Bortezomib-melphalan-prednisolone Regimen in Treatment-naïve Patients With Multiple Myeloma, Ineligible for Hematopoietic Transplantation
The 3-drug therapy of Bortezomib-Melphalan-Prednisolone (VMP) is a standard therapy that is commonly used currently in South Korea as a first-line treatment for treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation. Despite the fact that VMP therapy is outstanding in terms of cost-effectiveness, treatment discontinuation rates due to adverse drug reactions is high. In addition, when considering that the percentage of elderly patients aged 70 years or above in the target patient group is 20% or above, there have been attempts to devise a plan that can decrease side effects while maintaining effectiveness. For example, there have been previous reported cases of overseas applications of modified VMP therapies with reduced doses, but they have applied various combinations in terms of the total cycles, administration intervals, doses, etc. This study was planned to evaluate the overall safety and efficacy of VMP therapy by following up on the actual VMP therapies applied in domestic clinics, patient characteristics, side effect occurrences, administration discontinuation rates, survival data, etc., as well as to collect exploratory data for a more effective study of modified VMP therapies.
This study was planned to evaluate the overall safety and efficacy of VMP therapy by following up on the actual VMP therapies applied in domestic clinics, patient characteristics, side effect occurrences, administration discontinuation rates, survival data, etc., as well as to collect exploratory data for a more effective study of modified VMP therapies.
Read the detailed description
The data produced when subjects visit the hospital for treatment are collected in case report forms. The follow-up time specified in the following refer to the data collection time. That is, a subject's visit schedule is freely determined by the investigator based on the medical condition of the subject regardless of the follow-up time specified in this protocol, but data that are determined necessary in relation to the study among the data produced during the study period may be collected in CRFs.
In regard to various tests for monitoring of treatment effects including laboratory tests, the corresponding tests are not performed separately for this clinical study, and only those items with existing test results are collected. The following data are collected in CRFs during the study period.
- Demographic information of subjects
- Information on multiple myeloma disease (diagnosis date, diagnosis criteria and related test results, disease stage [ISS and revised ISS], number of osseous lesions)
- Intercurrent diseases
- Height and body weight
- ECOG PS
- IMWG Frailty score
- Laboratory results
- Radiologic results
- Bone marrow examination results
- Supportive therapy administered for symptoms related to multiple myeloma (drug / surgery / radiotherapy)
- Detailed information of administered VMP therapy
- Maintenance therapy / VMP replacement therapy
- Clinical response
- Survival
- Adverse drug reactions related to VMP therapy
- Serious adverse events/adverse drug reactions
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (progression-free survival)
the survival rate curve of PFS and the median, as well as the 95% confidence interval for this are presented. An event is 'confirmation of progressive disease (PD)' or 'death,' and others are processed as censored at the later time point between the final follow-up time point and the time point of final clinical response evaluation.
Measured: 18 Month after VMP therapy administration
Secondary outcomes (8)
ORR (Overall Response Rate)
The frequency and percentage of subjects who reach CR, VGPR, and PR even once after VMP therapy administration are calculated, and the 95% CI for the percentage is presented.
Measured: 18 Month after VMP therapy administration
CR (Complete Response)
The frequency and percentage of subjects who reach CR even once after VMP therapy administration are calculated, and the 95% CI for the percentage is presented
Measured: 18 Month after VMP therapy administration
Time to Response (TTR)
time to first response and time to best response; here, response must be higher than partial response (PR).
Measured: 18 Month after VMP therapy administration
Time to Progression (TTP)
'confirmation of progressive disease,' and others are processed as censored at the final follow-up time point or the time point of final clinical response evaluation.
Measured: 18 Month after VMP therapy administration
Time to Next Treatment (TTNT)
'administration of VMP replacement therapy (regardless of VMP therapy termination),' and others are processed as censored at the final follow-up
Measured: 18 Month after VMP therapy administration
OS (Overall Survival)
'death,' and others are processed as censored at the final time point with confirmed survival.
Measured: 18 Month after VMP therapy administration
Percentage of IMWG frailty scores at Cycle 5 and Cycle 9
The frequency and percentage of IMWG frailty scores (Fit: 0 points, Intermediate-fitness: 1 point, Frail: ≥2 points) per time point are presented. The mean, standard deviation, median, minimum value, and maximum value for the variance of IMWG frailty scores at VMP therapy Cycle 5 and Cycle 9 compared to the baseline are summarized with descriptive statistics
Measured: 18 Month after VMP therapy administration
Prognosis prediction factors
- Prognosis variables: PFS/TTR/TTP/OS
- Potential prediction factors: Age / ISS stage / revised ISS stage / number of osseous lesions / IMWG frailty score at baseline (0 points, 1 point, ≥2 points) / VMP administration pattern
Measured: 18 Month after VMP therapy administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start15 Nov 2018
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo Jae Kim, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151615
- Sponsor's protocol ID
- BR-BTZ-OS-401
- Acronym
- VISION
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center,Open, Longitudinal, Observational Study to Evaluate the Treatment Effectiveness and Safety of the Bortezomib-melphalan-prednisolone Regimen in Treatment-naïve Patients With Multiple Myeloma, Ineligible for Hematopoietic Transplantation
- ClinicalTrials.gov ID
- NCT04151615
- Acronym / sponsor ID
- VISION / BR-BTZ-OS-401
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 3-drug therapy of Bortezomib-Melphalan-Prednisolone (VMP) is a standard therapy that is commonly used currently in South Korea as a first-line treatment for treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation. Despite the fact that VMP therapy is outstanding in terms of cost-effectiveness, treatment discontinuation rates due to adverse drug reactions is high. In addition, when considering that the percentage of elderly patients aged 70 years or above in the target patient group is 20% or above, there have been attempts to devise a plan that can decrease side effects while maintaining effectiveness. For example, there have been previous reported cases of overseas applications of modified VMP therapies with reduced doses, but they have applied various combinations in terms of the total cycles, administration intervals, doses, etc. This study was planned to evaluate the overall safety and efficacy of VMP therapy by following up on the actual VMP therapies applied in domestic clinics, patient characteristics, side effect occurrences, administration discontinuation rates, survival data, etc., as well as to collect exploratory data for a more effective study of modified VMP therapies.
This study was planned to evaluate the overall safety and efficacy of VMP therapy by following up on the actual VMP therapies applied in domestic clinics, patient characteristics, side effect occurrences, administration discontinuation rates, survival data, etc., as well as to collect exploratory data for a more effective study of modified VMP therapies.
Detailed description
The data produced when subjects visit the hospital for treatment are collected in case report forms. The follow-up time specified in the following refer to the data collection time. That is, a subject's visit schedule is freely determined by the investigator based on the medical condition of the subject regardless of the follow-up time specified in this protocol, but data that are determined necessary in relation to the study among the data produced during the study period may be collected in CRFs.
In regard to various tests for monitoring of treatment effects including laboratory tests, the corresponding tests are not performed separately for this clinical study, and only those items with existing test results are collected. The following data are collected in CRFs during the study period.
- Demographic information of subjects
- Information on multiple myeloma disease (diagnosis date, diagnosis criteria and related test results, disease stage [ISS and revised ISS], number of osseous lesions)
- Intercurrent diseases
- Height and body weight
- ECOG PS
- IMWG Frailty score
- Laboratory results
- Radiologic results
- Bone marrow examination results
- Supportive therapy administered for symptoms related to multiple myeloma (drug / surgery / radiotherapy)
- Detailed information of administered VMP therapy
- Maintenance therapy / VMP replacement therapy
- Clinical response
- Survival
- Adverse drug reactions related to VMP therapy
- Serious adverse events/adverse drug reactions
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation
Key inclusion criteria (11 listed)
- Patients who provide written consent on the informed consent form for use of personal information after listening to an explanation regarding the purpose, method, etc., of this clinical study
- Adult males and females aged 19 years or above
- Patients without previous experience of treatment for multiple myeloma who have been evaluated as ineligible for hematopoietic transplantation
- Patients scheduled to receive the 3-drug combination (VMP therapy) treatment
- Patients with expected survival period of 6 months or more
Key exclusion criteria (4 listed)
- Patients who have been newly diagnosed with other primary cancers within the last 5 years that can affect the treatment or prognosis of multiple myeloma
- Pregnant women and breast-feeding women
- Patients who are currently participating in other clinical studies (drug or medical device clinical studies) or planning to participate in other clinical studies during the study participation period
- Patients who are determined ineligible to participate in the study by other judgments of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS (progression-free survival)
Time frame: 18 Month after VMP therapy administration
the survival rate curve of PFS and the median, as well as the 95% confidence interval for this are presented. An event is 'confirmation of progressive disease (PD)' or 'death,' and others are processed as censored at the later time point between the final follow-up time point and the time point of final clinical response evaluation.
8 secondary outcomes
ORR (Overall Response Rate)
Time frame: 18 Month after VMP therapy administration
CR (Complete Response)
Time frame: 18 Month after VMP therapy administration
Time to Response (TTR)
Time frame: 18 Month after VMP therapy administration
Time to Progression (TTP)
Time frame: 18 Month after VMP therapy administration
Time to Next Treatment (TTNT)
Time frame: 18 Month after VMP therapy administration
OS (Overall Survival)
Time frame: 18 Month after VMP therapy administration
Percentage of IMWG frailty scores at Cycle 5 and Cycle 9
Time frame: 18 Month after VMP therapy administration
Prognosis prediction factors
Time frame: 18 Month after VMP therapy administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo Jae Kim study director
Boryung Pharmaceutical Co., Ltd
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Boryung Pharmaceutical Co., Ltd at 24 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 11 inclusion and 4 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
PFS (progression-free survival) (time frame: 18 Month after VMP therapy administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.