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VISION: VMP Regimen - Safety, Efficacy, and Optimal Dose Finding Study for Patients With Multiple Myeloma

Sponsor
Boryung Pharmaceutical Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04151615
Collaborator
(none)
203
Enrollment
24
Locations
50.5
Anticipated Duration (Months)
8.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    203 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Nov 15, 2018
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Jan 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients

    Treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation

    Outcome Measures

    Primary Outcome Measures

    1. PFS (progression-free survival) [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.

    Secondary Outcome Measures

    1. ORR (Overall Response Rate) [18 Month after VMP therapy administration]

      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.

    2. CR (Complete Response) [18 Month after VMP therapy administration]

      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

    3. Time to Response (TTR) [18 Month after VMP therapy administration]

      time to first response and time to best response; here, response must be higher than partial response (PR).

    4. Time to Progression (TTP) [18 Month after VMP therapy administration]

      '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.

    5. Time to Next Treatment (TTNT) [18 Month after VMP therapy administration]

      'administration of VMP replacement therapy (regardless of VMP therapy termination),' and others are processed as censored at the final follow-up

    6. OS (Overall Survival) [18 Month after VMP therapy administration]

      'death,' and others are processed as censored at the final time point with confirmed survival.

    7. Percentage of IMWG frailty scores at Cycle 5 and Cycle 9 [18 Month after VMP therapy administration]

      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

    8. Prognosis prediction factors [18 Month after VMP therapy administration]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soonchunhyang University Bucheon hospital Bucheon Korea, Republic of
    2 Inje university Haeundae Paik Hospital Busan Korea, Republic of
    3 Kosin University Gospel hospital Busan Korea, Republic of
    4 Pusan national University Hospital Busan Korea, Republic of
    5 Chungbuk national university Hospital Chungbuk Korea, Republic of
    6 Dankook University Hospital Chungnam Korea, Republic of
    7 Keimyung University Hospital(Dongsan Medical Center) Daegu Korea, Republic of
    8 Yeungnam University Medical Center Daegu Korea, Republic of
    9 Chungnam National University Hospital Daejeon Korea, Republic of
    10 National Cancer Center Goyang Korea, Republic of
    11 Gyeongsang National University Changwon Hospital Gyeongsang Korea, Republic of
    12 Chonnam National University Hwasun Hospital Hwasun Korea, Republic of
    13 Gachon University Gil Medical Center Incheon Korea, Republic of
    14 Chung-Ang University Hospital Seoul Korea, Republic of
    15 Kangbuk Samsung Hospital Seoul Korea, Republic of
    16 Korea University Anam Hospital Seoul Korea, Republic of
    17 Samsung Medical Center Seoul Korea, Republic of
    18 Seoul National University Hospital Seoul Korea, Republic of
    19 Severance Hospital Seoul Korea, Republic of
    20 Soonchunhyang University Hospital Seoul Korea, Republic of
    21 The Catholic University of Korea, Seoul ST. Mary's Hospital Seoul Korea, Republic of
    22 Ajou University Medical Center Suwon Korea, Republic of
    23 Ulsan University hospital Ulsan Korea, Republic of
    24 Wonju Severance Christian Hospital Wonju Korea, Republic of

    Sponsors and Collaborators

    • Boryung Pharmaceutical Co., Ltd

    Investigators

    • Study Director: Hyo Jae Kim, Boryung Pharmaceutical Co., Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boryung Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT04151615
    Other Study ID Numbers:
    • BR-BTZ-OS-401
    First Posted:
    Nov 5, 2019
    Last Update Posted:
    Dec 10, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Boryung Pharmaceutical Co., Ltd
    Multiple Myeloma
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Dec 10, 2020