Clinical trial NCT04151615: VMP Regimen - Safety, Efficacy, and Optimal Dose Finding Study for Patients With Multiple Myeloma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 203
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: PFS (progression-free survival)
timeFrame: 18 Month after VMP therapy administration
Secondary outcomes:
measure: ORR (Overall Response Rate)
timeFrame: 18 Month after VMP therapy administration
measure: CR (Complete Response)
timeFrame: 18 Month after VMP therapy administration
measure: Time to Response (TTR)
timeFrame: 18 Month after VMP therapy administration
measure: Time to Progression (TTP)
timeFrame: 18 Month after VMP therapy administration
measure: Time to Next Treatment (TTNT)
timeFrame: 18 Month after VMP therapy administration
measure: OS (Overall Survival)
timeFrame: 18 Month after VMP therapy administration
measure: Percentage of IMWG frailty scores at Cycle 5 and Cycle 9
timeFrame: 18 Month after VMP therapy administration
measure: Prognosis prediction factors
timeFrame: 18 Month after VMP therapy administration
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon hospital
city: Busan
country: Korea, Republic of
facility: Inje university Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel hospital
city: Busan
country: Korea, Republic of
facility: Pusan national University Hospital
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk national university Hospital
city: Chungnam
country: Korea, Republic of
facility: Dankook University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Hospital(Dongsan Medical Center)
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Gyeongsang
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: Hyo Jae Kim
role: STUDY_DIRECTOR
References: