VMP Regimen - Safety, Efficacy, and Optimal Dose Finding Study for Patients With Multiple Myeloma
VISION
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
1 other identifier
observational
203
1 country
24
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2018
CompletedFirst Submitted
Initial submission to the registry
November 1, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2023
CompletedJune 15, 2023
June 1, 2023
4.2 years
November 1, 2019
June 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
18 Month after VMP therapy administration
Secondary Outcomes (8)
ORR (Overall Response Rate)
18 Month after VMP therapy administration
CR (Complete Response)
18 Month after VMP therapy administration
Time to Response (TTR)
18 Month after VMP therapy administration
Time to Progression (TTP)
18 Month after VMP therapy administration
Time to Next Treatment (TTNT)
18 Month after VMP therapy administration
- +3 more secondary outcomes
Study Arms (1)
Patients
Treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation
Eligibility Criteria
Treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Soonchunhyang University Bucheon hospital
Bucheon-si, South Korea
Inje university Haeundae Paik Hospital
Busan, South Korea
Kosin University Gospel hospital
Busan, South Korea
Pusan national University Hospital
Busan, South Korea
Keimyung University Hospital(Dongsan Medical Center)
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
National Cancer Center
Goyang, South Korea
Gyeongsang National University Changwon Hospital
Gyeongsang, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Chungbuk national university Hospital
Jungbuk, South Korea
Dankook University Hospital
Jungnam, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Soonchunhyang University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Ajou University Medical Center
Suwon, South Korea
Ulsan University hospital
Ulsan, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hyo Jae Kim
Boryung Pharmaceutical Co., Ltd
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2019
First Posted
November 5, 2019
Study Start
November 15, 2018
Primary Completion
January 11, 2023
Study Completion
January 11, 2023
Last Updated
June 15, 2023
Record last verified: 2023-06