Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma: a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12)

Kazutaka Sunami, Morio Matsumoto, Shin ichi Fuchida, Eijiro Omoto, Hiroyuki Takamatsu, Yoko Adachi, Ilsong Choi, Naohito Fujishima, Toru Kiguchi, Toshihiro Miyamoto, Akio Maeda, Junji Suzumiya, Ryosuke Yamamura, Koji Nagafuji, Tomonori Nakazato, Yoshiaki Kuroda, Toshiaki Yujiri, Yasushi Takamatsu, Mine Harada, Koichi Akashi

Research output: Contribution to journalArticle

Abstract

Background: The Japan Study Group for Cell Therapy and Transplantation (JSCT) organized a phase II study to evaluate the efficacy and safety of a treatment protocol (JSCT-MM12) for multiple myeloma (MM) patients who were previously untreated and transplantation-eligible. Since bortezomib-based therapy is known to be effective for MM, the protocol is intensified more than the previous protocol (JSCT-MM10) and comprised the subsequent treatments: bortezomib + cyclophosphamide + dexamethasone (VCD) induction; bortezomib + high-dose-melphalan (B-HDM) conditioning with autologous stem cell transplantation (ASCT); bortezomib + thalidomide + dexamethasone (VTD) consolidation; and lenalidomide (LEN) maintenance. Methods: Sixty-four symptomatic patients aged between 20 and 65 years were enrolled for treatment and received three cycles of VCD, followed by cyclophosphamide administration for autologous stem cell harvest and B-HDM/ASCT, and subsequently two cycles of VTD, after that LEN for 1 year. Results: Complete response (CR)/stringent CR (sCR) rates for induction, ASCT, consolidation, and maintenance therapies were 20, 39, 52, and 56%, respectively. The grade 3/4 toxicities (≥ 10%) with VCD treatment included neutropenia (27%), anemia (19%), and thrombocytopenia (11%). There was no treatment-related mortality. After median follow-up of 41 months, estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 64% and 88%, respectively. The high-risk group revealed lower CR/sCR, PFS, and OS than the standard-risk group. Conclusions: The study revealed that the treatment protocol consisting of VCD induction, B-HDM/ASCT followed by VTD consolidation, and LEN maintenance could produce highly beneficial responses and favorable tolerability in newly diagnosed MM. However, future study is required for improving treatment in the high-risk group.

Original languageEnglish
JournalInternational Journal of Clinical Oncology
DOIs
Publication statusPublished - Jan 1 2019

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Cell Transplantation
Stem Cell Transplantation
Group Psychotherapy
Cell- and Tissue-Based Therapy
Multiple Myeloma
Japan
Melphalan
Clinical Protocols
Cyclophosphamide
Dexamethasone
Therapeutics
Disease-Free Survival
Maintenance
Thalidomide
Bortezomib
Neutropenia
Thrombocytopenia
Anemia
Stem Cells
Survival Rate

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma : a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12). / Sunami, Kazutaka; Matsumoto, Morio; Fuchida, Shin ichi; Omoto, Eijiro; Takamatsu, Hiroyuki; Adachi, Yoko; Choi, Ilsong; Fujishima, Naohito; Kiguchi, Toru; Miyamoto, Toshihiro; Maeda, Akio; Suzumiya, Junji; Yamamura, Ryosuke; Nagafuji, Koji; Nakazato, Tomonori; Kuroda, Yoshiaki; Yujiri, Toshiaki; Takamatsu, Yasushi; Harada, Mine; Akashi, Koichi.

In: International Journal of Clinical Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Sunami, K, Matsumoto, M, Fuchida, SI, Omoto, E, Takamatsu, H, Adachi, Y, Choi, I, Fujishima, N, Kiguchi, T, Miyamoto, T, Maeda, A, Suzumiya, J, Yamamura, R, Nagafuji, K, Nakazato, T, Kuroda, Y, Yujiri, T, Takamatsu, Y, Harada, M & Akashi, K 2019, 'Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma: a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12)', International Journal of Clinical Oncology. https://doi.org/10.1007/s10147-019-01436-8
Sunami, Kazutaka ; Matsumoto, Morio ; Fuchida, Shin ichi ; Omoto, Eijiro ; Takamatsu, Hiroyuki ; Adachi, Yoko ; Choi, Ilsong ; Fujishima, Naohito ; Kiguchi, Toru ; Miyamoto, Toshihiro ; Maeda, Akio ; Suzumiya, Junji ; Yamamura, Ryosuke ; Nagafuji, Koji ; Nakazato, Tomonori ; Kuroda, Yoshiaki ; Yujiri, Toshiaki ; Takamatsu, Yasushi ; Harada, Mine ; Akashi, Koichi. / Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma : a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12). In: International Journal of Clinical Oncology. 2019.
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abstract = "Background: The Japan Study Group for Cell Therapy and Transplantation (JSCT) organized a phase II study to evaluate the efficacy and safety of a treatment protocol (JSCT-MM12) for multiple myeloma (MM) patients who were previously untreated and transplantation-eligible. Since bortezomib-based therapy is known to be effective for MM, the protocol is intensified more than the previous protocol (JSCT-MM10) and comprised the subsequent treatments: bortezomib + cyclophosphamide + dexamethasone (VCD) induction; bortezomib + high-dose-melphalan (B-HDM) conditioning with autologous stem cell transplantation (ASCT); bortezomib + thalidomide + dexamethasone (VTD) consolidation; and lenalidomide (LEN) maintenance. Methods: Sixty-four symptomatic patients aged between 20 and 65 years were enrolled for treatment and received three cycles of VCD, followed by cyclophosphamide administration for autologous stem cell harvest and B-HDM/ASCT, and subsequently two cycles of VTD, after that LEN for 1 year. Results: Complete response (CR)/stringent CR (sCR) rates for induction, ASCT, consolidation, and maintenance therapies were 20, 39, 52, and 56{\%}, respectively. The grade 3/4 toxicities (≥ 10{\%}) with VCD treatment included neutropenia (27{\%}), anemia (19{\%}), and thrombocytopenia (11{\%}). There was no treatment-related mortality. After median follow-up of 41 months, estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 64{\%} and 88{\%}, respectively. The high-risk group revealed lower CR/sCR, PFS, and OS than the standard-risk group. Conclusions: The study revealed that the treatment protocol consisting of VCD induction, B-HDM/ASCT followed by VTD consolidation, and LEN maintenance could produce highly beneficial responses and favorable tolerability in newly diagnosed MM. However, future study is required for improving treatment in the high-risk group.",
author = "Kazutaka Sunami and Morio Matsumoto and Fuchida, {Shin ichi} and Eijiro Omoto and Hiroyuki Takamatsu and Yoko Adachi and Ilsong Choi and Naohito Fujishima and Toru Kiguchi and Toshihiro Miyamoto and Akio Maeda and Junji Suzumiya and Ryosuke Yamamura and Koji Nagafuji and Tomonori Nakazato and Yoshiaki Kuroda and Toshiaki Yujiri and Yasushi Takamatsu and Mine Harada and Koichi Akashi",
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T1 - Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma

T2 - a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12)

AU - Sunami, Kazutaka

AU - Matsumoto, Morio

AU - Fuchida, Shin ichi

AU - Omoto, Eijiro

AU - Takamatsu, Hiroyuki

AU - Adachi, Yoko

AU - Choi, Ilsong

AU - Fujishima, Naohito

AU - Kiguchi, Toru

AU - Miyamoto, Toshihiro

AU - Maeda, Akio

AU - Suzumiya, Junji

AU - Yamamura, Ryosuke

AU - Nagafuji, Koji

AU - Nakazato, Tomonori

AU - Kuroda, Yoshiaki

AU - Yujiri, Toshiaki

AU - Takamatsu, Yasushi

AU - Harada, Mine

AU - Akashi, Koichi

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: The Japan Study Group for Cell Therapy and Transplantation (JSCT) organized a phase II study to evaluate the efficacy and safety of a treatment protocol (JSCT-MM12) for multiple myeloma (MM) patients who were previously untreated and transplantation-eligible. Since bortezomib-based therapy is known to be effective for MM, the protocol is intensified more than the previous protocol (JSCT-MM10) and comprised the subsequent treatments: bortezomib + cyclophosphamide + dexamethasone (VCD) induction; bortezomib + high-dose-melphalan (B-HDM) conditioning with autologous stem cell transplantation (ASCT); bortezomib + thalidomide + dexamethasone (VTD) consolidation; and lenalidomide (LEN) maintenance. Methods: Sixty-four symptomatic patients aged between 20 and 65 years were enrolled for treatment and received three cycles of VCD, followed by cyclophosphamide administration for autologous stem cell harvest and B-HDM/ASCT, and subsequently two cycles of VTD, after that LEN for 1 year. Results: Complete response (CR)/stringent CR (sCR) rates for induction, ASCT, consolidation, and maintenance therapies were 20, 39, 52, and 56%, respectively. The grade 3/4 toxicities (≥ 10%) with VCD treatment included neutropenia (27%), anemia (19%), and thrombocytopenia (11%). There was no treatment-related mortality. After median follow-up of 41 months, estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 64% and 88%, respectively. The high-risk group revealed lower CR/sCR, PFS, and OS than the standard-risk group. Conclusions: The study revealed that the treatment protocol consisting of VCD induction, B-HDM/ASCT followed by VTD consolidation, and LEN maintenance could produce highly beneficial responses and favorable tolerability in newly diagnosed MM. However, future study is required for improving treatment in the high-risk group.

AB - Background: The Japan Study Group for Cell Therapy and Transplantation (JSCT) organized a phase II study to evaluate the efficacy and safety of a treatment protocol (JSCT-MM12) for multiple myeloma (MM) patients who were previously untreated and transplantation-eligible. Since bortezomib-based therapy is known to be effective for MM, the protocol is intensified more than the previous protocol (JSCT-MM10) and comprised the subsequent treatments: bortezomib + cyclophosphamide + dexamethasone (VCD) induction; bortezomib + high-dose-melphalan (B-HDM) conditioning with autologous stem cell transplantation (ASCT); bortezomib + thalidomide + dexamethasone (VTD) consolidation; and lenalidomide (LEN) maintenance. Methods: Sixty-four symptomatic patients aged between 20 and 65 years were enrolled for treatment and received three cycles of VCD, followed by cyclophosphamide administration for autologous stem cell harvest and B-HDM/ASCT, and subsequently two cycles of VTD, after that LEN for 1 year. Results: Complete response (CR)/stringent CR (sCR) rates for induction, ASCT, consolidation, and maintenance therapies were 20, 39, 52, and 56%, respectively. The grade 3/4 toxicities (≥ 10%) with VCD treatment included neutropenia (27%), anemia (19%), and thrombocytopenia (11%). There was no treatment-related mortality. After median follow-up of 41 months, estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 64% and 88%, respectively. The high-risk group revealed lower CR/sCR, PFS, and OS than the standard-risk group. Conclusions: The study revealed that the treatment protocol consisting of VCD induction, B-HDM/ASCT followed by VTD consolidation, and LEN maintenance could produce highly beneficial responses and favorable tolerability in newly diagnosed MM. However, future study is required for improving treatment in the high-risk group.

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