A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalanprednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma

Min Kyoung Kim, Kihyun Kim, Chang Ki Min, Jae Yong Kwak, Sang Byung Bae, Sung Soo Yoon, Je Jung Lee, Ki Hwan Kim, Seung Hyun Nam, Yeung Chul Mun, Hyo Jung Kim, Sung Hwa Bae, Ho Jin Shin, Jung Hee Lee, Joon Seong Park, Seong Hyun Jeong, Mark Hong Lee, Yang Soo Kim, Ho Sup Lee, Keon Woo ParkWon Sik Lee, Sang Min Lee, Jeong Ok Lee, Myung Soo Hyun, Deog Yeon Jo, Sung Nam Lim, Jae Hoon Lee, Do Yeun Cho, Young Rok Do, Jeong A. Kim, Seong Kyu Park, Jin Seok Kim, Soo Jeong Kim, Hawk Kim, Hyeon Gyu Yi, Joon Ho Moon, Chul Won Choi, Sung Hyun Kim, Young Don Joo, Hoon Gu Kim, Byung Soo Kim, Moo Rim Park, Moo Kon Song, Su Youn Kim

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Bortezomib-melphalan-prednisone (VMP) showed superior efficacy versus MP as first-line treatment for transplantation-ineligible multiple myeloma (MM). This study investigated the efficacy of VMP for Korean patients with MM. Overall, 177 MM patients received 9 cycles of VMP in this prospective, multicenter, observational study. The primary endpoint was 2-year progression-free survival (PFS). Thirty-nine (22%) patients were aged ≥ 75 years and 83 (47.4%) patients had International Staging System stage III. A median of 5 cycles were delivered. Overall response rate (ORR) was 72.9%, and complete response (CR) rate was 20.3%. With a median follow-up of 11.9 months, median PFS was 17 months. The 2-year PFS and overall survival (OS) rates were 29.2% and 80.0%, respectively. Median OS was not reached. PFS was significantly different depending on performance status (Eastern Cooperative Oncology Group < 2 vs. ≥ 2; p = 0.0002), β2-microglobulin level (< 5.5 vs. = 5.5 mg/L; p = 0.0481), and cumulative dose of bortezomib (< 35.1 vs. = 35.1 mg/ m2; p < 0001). The common adverse events (AEs) were in line with the well-known toxicity profiles associated with VMP. In conclusion, VMP is a feasible and effective front-line treatment for transplantineligible older patients with MM in Korea. Continuing therapy with prompt adjustment of treatment according to AEs may be important to improve outcomes of elderly patients.

Original languageEnglish
Pages (from-to)37605-37618
Number of pages14
JournalOncotarget
Volume8
Issue number23
DOIs
Publication statusPublished - 2017

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Stem Cell Transplantation
Multiple Myeloma
Multicenter Studies
Observational Studies
Safety
Disease-Free Survival
Therapeutics
Melphalan
Korea
Prednisone
Bortezomib
Survival Rate
Transplantation
Survival

Keywords

  • Aged
  • Bortezomib
  • Combination
  • Drug therapy
  • Multiple myeloma

ASJC Scopus subject areas

  • Oncology

Cite this

A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalanprednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma. / Kim, Min Kyoung; Kim, Kihyun; Min, Chang Ki; Kwak, Jae Yong; Bae, Sang Byung; Yoon, Sung Soo; Lee, Je Jung; Kim, Ki Hwan; Nam, Seung Hyun; Mun, Yeung Chul; Kim, Hyo Jung; Bae, Sung Hwa; Shin, Ho Jin; Lee, Jung Hee; Park, Joon Seong; Jeong, Seong Hyun; Lee, Mark Hong; Kim, Yang Soo; Lee, Ho Sup; Park, Keon Woo; Lee, Won Sik; Lee, Sang Min; Lee, Jeong Ok; Hyun, Myung Soo; Jo, Deog Yeon; Lim, Sung Nam; Lee, Jae Hoon; Cho, Do Yeun; Do, Young Rok; Kim, Jeong A.; Park, Seong Kyu; Kim, Jin Seok; Kim, Soo Jeong; Kim, Hawk; Yi, Hyeon Gyu; Moon, Joon Ho; Choi, Chul Won; Kim, Sung Hyun; Joo, Young Don; Kim, Hoon Gu; Kim, Byung Soo; Park, Moo Rim; Song, Moo Kon; Kim, Su Youn.

In: Oncotarget, Vol. 8, No. 23, 2017, p. 37605-37618.

Research output: Contribution to journalArticle

Kim, MK, Kim, K, Min, CK, Kwak, JY, Bae, SB, Yoon, SS, Lee, JJ, Kim, KH, Nam, SH, Mun, YC, Kim, HJ, Bae, SH, Shin, HJ, Lee, JH, Park, JS, Jeong, SH, Lee, MH, Kim, YS, Lee, HS, Park, KW, Lee, WS, Lee, SM, Lee, JO, Hyun, MS, Jo, DY, Lim, SN, Lee, JH, Cho, DY, Do, YR, Kim, JA, Park, SK, Kim, JS, Kim, SJ, Kim, H, Yi, HG, Moon, JH, Choi, CW, Kim, SH, Joo, YD, Kim, HG, Kim, BS, Park, MR, Song, MK & Kim, SY 2017, 'A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalanprednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma', Oncotarget, vol. 8, no. 23, pp. 37605-37618. https://doi.org/10.18632/oncotarget.16790
Kim, Min Kyoung ; Kim, Kihyun ; Min, Chang Ki ; Kwak, Jae Yong ; Bae, Sang Byung ; Yoon, Sung Soo ; Lee, Je Jung ; Kim, Ki Hwan ; Nam, Seung Hyun ; Mun, Yeung Chul ; Kim, Hyo Jung ; Bae, Sung Hwa ; Shin, Ho Jin ; Lee, Jung Hee ; Park, Joon Seong ; Jeong, Seong Hyun ; Lee, Mark Hong ; Kim, Yang Soo ; Lee, Ho Sup ; Park, Keon Woo ; Lee, Won Sik ; Lee, Sang Min ; Lee, Jeong Ok ; Hyun, Myung Soo ; Jo, Deog Yeon ; Lim, Sung Nam ; Lee, Jae Hoon ; Cho, Do Yeun ; Do, Young Rok ; Kim, Jeong A. ; Park, Seong Kyu ; Kim, Jin Seok ; Kim, Soo Jeong ; Kim, Hawk ; Yi, Hyeon Gyu ; Moon, Joon Ho ; Choi, Chul Won ; Kim, Sung Hyun ; Joo, Young Don ; Kim, Hoon Gu ; Kim, Byung Soo ; Park, Moo Rim ; Song, Moo Kon ; Kim, Su Youn. / A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalanprednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma. In: Oncotarget. 2017 ; Vol. 8, No. 23. pp. 37605-37618.
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title = "A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalanprednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma",
abstract = "Bortezomib-melphalan-prednisone (VMP) showed superior efficacy versus MP as first-line treatment for transplantation-ineligible multiple myeloma (MM). This study investigated the efficacy of VMP for Korean patients with MM. Overall, 177 MM patients received 9 cycles of VMP in this prospective, multicenter, observational study. The primary endpoint was 2-year progression-free survival (PFS). Thirty-nine (22{\%}) patients were aged ≥ 75 years and 83 (47.4{\%}) patients had International Staging System stage III. A median of 5 cycles were delivered. Overall response rate (ORR) was 72.9{\%}, and complete response (CR) rate was 20.3{\%}. With a median follow-up of 11.9 months, median PFS was 17 months. The 2-year PFS and overall survival (OS) rates were 29.2{\%} and 80.0{\%}, respectively. Median OS was not reached. PFS was significantly different depending on performance status (Eastern Cooperative Oncology Group < 2 vs. ≥ 2; p = 0.0002), β2-microglobulin level (< 5.5 vs. = 5.5 mg/L; p = 0.0481), and cumulative dose of bortezomib (< 35.1 vs. = 35.1 mg/ m2; p < 0001). The common adverse events (AEs) were in line with the well-known toxicity profiles associated with VMP. In conclusion, VMP is a feasible and effective front-line treatment for transplantineligible older patients with MM in Korea. Continuing therapy with prompt adjustment of treatment according to AEs may be important to improve outcomes of elderly patients.",
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author = "Kim, {Min Kyoung} and Kihyun Kim and Min, {Chang Ki} and Kwak, {Jae Yong} and Bae, {Sang Byung} and Yoon, {Sung Soo} and Lee, {Je Jung} and Kim, {Ki Hwan} and Nam, {Seung Hyun} and Mun, {Yeung Chul} and Kim, {Hyo Jung} and Bae, {Sung Hwa} and Shin, {Ho Jin} and Lee, {Jung Hee} and Park, {Joon Seong} and Jeong, {Seong Hyun} and Lee, {Mark Hong} and Kim, {Yang Soo} and Lee, {Ho Sup} and Park, {Keon Woo} and Lee, {Won Sik} and Lee, {Sang Min} and Lee, {Jeong Ok} and Hyun, {Myung Soo} and Jo, {Deog Yeon} and Lim, {Sung Nam} and Lee, {Jae Hoon} and Cho, {Do Yeun} and Do, {Young Rok} and Kim, {Jeong A.} and Park, {Seong Kyu} and Kim, {Jin Seok} and Kim, {Soo Jeong} and Hawk Kim and Yi, {Hyeon Gyu} and Moon, {Joon Ho} and Choi, {Chul Won} and Kim, {Sung Hyun} and Joo, {Young Don} and Kim, {Hoon Gu} and Kim, {Byung Soo} and Park, {Moo Rim} and Song, {Moo Kon} and Kim, {Su Youn}",
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T1 - A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalanprednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma

AU - Kim, Min Kyoung

AU - Kim, Kihyun

AU - Min, Chang Ki

AU - Kwak, Jae Yong

AU - Bae, Sang Byung

AU - Yoon, Sung Soo

AU - Lee, Je Jung

AU - Kim, Ki Hwan

AU - Nam, Seung Hyun

AU - Mun, Yeung Chul

AU - Kim, Hyo Jung

AU - Bae, Sung Hwa

AU - Shin, Ho Jin

AU - Lee, Jung Hee

AU - Park, Joon Seong

AU - Jeong, Seong Hyun

AU - Lee, Mark Hong

AU - Kim, Yang Soo

AU - Lee, Ho Sup

AU - Park, Keon Woo

AU - Lee, Won Sik

AU - Lee, Sang Min

AU - Lee, Jeong Ok

AU - Hyun, Myung Soo

AU - Jo, Deog Yeon

AU - Lim, Sung Nam

AU - Lee, Jae Hoon

AU - Cho, Do Yeun

AU - Do, Young Rok

AU - Kim, Jeong A.

AU - Park, Seong Kyu

AU - Kim, Jin Seok

AU - Kim, Soo Jeong

AU - Kim, Hawk

AU - Yi, Hyeon Gyu

AU - Moon, Joon Ho

AU - Choi, Chul Won

AU - Kim, Sung Hyun

AU - Joo, Young Don

AU - Kim, Hoon Gu

AU - Kim, Byung Soo

AU - Park, Moo Rim

AU - Song, Moo Kon

AU - Kim, Su Youn

PY - 2017

Y1 - 2017

N2 - Bortezomib-melphalan-prednisone (VMP) showed superior efficacy versus MP as first-line treatment for transplantation-ineligible multiple myeloma (MM). This study investigated the efficacy of VMP for Korean patients with MM. Overall, 177 MM patients received 9 cycles of VMP in this prospective, multicenter, observational study. The primary endpoint was 2-year progression-free survival (PFS). Thirty-nine (22%) patients were aged ≥ 75 years and 83 (47.4%) patients had International Staging System stage III. A median of 5 cycles were delivered. Overall response rate (ORR) was 72.9%, and complete response (CR) rate was 20.3%. With a median follow-up of 11.9 months, median PFS was 17 months. The 2-year PFS and overall survival (OS) rates were 29.2% and 80.0%, respectively. Median OS was not reached. PFS was significantly different depending on performance status (Eastern Cooperative Oncology Group < 2 vs. ≥ 2; p = 0.0002), β2-microglobulin level (< 5.5 vs. = 5.5 mg/L; p = 0.0481), and cumulative dose of bortezomib (< 35.1 vs. = 35.1 mg/ m2; p < 0001). The common adverse events (AEs) were in line with the well-known toxicity profiles associated with VMP. In conclusion, VMP is a feasible and effective front-line treatment for transplantineligible older patients with MM in Korea. Continuing therapy with prompt adjustment of treatment according to AEs may be important to improve outcomes of elderly patients.

AB - Bortezomib-melphalan-prednisone (VMP) showed superior efficacy versus MP as first-line treatment for transplantation-ineligible multiple myeloma (MM). This study investigated the efficacy of VMP for Korean patients with MM. Overall, 177 MM patients received 9 cycles of VMP in this prospective, multicenter, observational study. The primary endpoint was 2-year progression-free survival (PFS). Thirty-nine (22%) patients were aged ≥ 75 years and 83 (47.4%) patients had International Staging System stage III. A median of 5 cycles were delivered. Overall response rate (ORR) was 72.9%, and complete response (CR) rate was 20.3%. With a median follow-up of 11.9 months, median PFS was 17 months. The 2-year PFS and overall survival (OS) rates were 29.2% and 80.0%, respectively. Median OS was not reached. PFS was significantly different depending on performance status (Eastern Cooperative Oncology Group < 2 vs. ≥ 2; p = 0.0002), β2-microglobulin level (< 5.5 vs. = 5.5 mg/L; p = 0.0481), and cumulative dose of bortezomib (< 35.1 vs. = 35.1 mg/ m2; p < 0001). The common adverse events (AEs) were in line with the well-known toxicity profiles associated with VMP. In conclusion, VMP is a feasible and effective front-line treatment for transplantineligible older patients with MM in Korea. Continuing therapy with prompt adjustment of treatment according to AEs may be important to improve outcomes of elderly patients.

KW - Aged

KW - Bortezomib

KW - Combination

KW - Drug therapy

KW - Multiple myeloma

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U2 - 10.18632/oncotarget.16790

DO - 10.18632/oncotarget.16790

M3 - Article

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VL - 8

SP - 37605

EP - 37618

JO - Oncotarget

JF - Oncotarget

SN - 1949-2553

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