Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial

We conducted a phase II trial to prospectively evaluate the efficacy and safety of bortezomib-cyclophosphamide-dexamethasone (VCD) induction, autologous stem cell transplantation (ASCT), VCD consolidation, and bortezomib maintenance in transplant-eligible newly diagnosed multiple myeloma (NDMM) pati...

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Veröffentlicht in:Hematology (Luxembourg) 2022-12, Vol.27 (1), p.239-248
Hauptverfasser: Muranushi, Hiroyuki, Kanda, Junya, Kobayashi, Masayuki, Maeda, Takeshi, Kitano, Toshiyuki, Tsuji, Masaaki, Ueda, Yasunori, Ishikawa, Takayuki, Nohgawa, Masaharu, Watanabe, Mitsumasa, Imada, Kazunori, Moriguchi, Toshinori, Itoh, Mitsuru, Ohno, Hitoshi, Yonezawa, Akihito, Hirata, Hirokazu, Arima, Nobuyoshi, Asagoe, Kohsuke, Anzai, Naoyuki, Nagata, Kayoko, Yasuno, Shinji, Kuwabara, Yoshihiro, Kitao, Hiromi, Kim, Ihhwa, Kawagishi, Kiyomi, Ueshima, Kenji, Tominari, Shinjiro, Nakayama, Takeo, Yamashita, Kouhei, Takaori-Kondo, Akifumi
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container_issue 1
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container_title Hematology (Luxembourg)
container_volume 27
creator Muranushi, Hiroyuki
Kanda, Junya
Kobayashi, Masayuki
Maeda, Takeshi
Kitano, Toshiyuki
Tsuji, Masaaki
Ueda, Yasunori
Ishikawa, Takayuki
Nohgawa, Masaharu
Watanabe, Mitsumasa
Imada, Kazunori
Moriguchi, Toshinori
Itoh, Mitsuru
Ohno, Hitoshi
Yonezawa, Akihito
Hirata, Hirokazu
Arima, Nobuyoshi
Asagoe, Kohsuke
Anzai, Naoyuki
Nagata, Kayoko
Yasuno, Shinji
Kuwabara, Yoshihiro
Kitao, Hiromi
Kim, Ihhwa
Kawagishi, Kiyomi
Ueshima, Kenji
Tominari, Shinjiro
Nakayama, Takeo
Yamashita, Kouhei
Takaori-Kondo, Akifumi
description We conducted a phase II trial to prospectively evaluate the efficacy and safety of bortezomib-cyclophosphamide-dexamethasone (VCD) induction, autologous stem cell transplantation (ASCT), VCD consolidation, and bortezomib maintenance in transplant-eligible newly diagnosed multiple myeloma (NDMM) patients in Japan (UMIN000010542). From 2013 to 2016, 42 patients with a median age of 58 (range 42-65) years with NDMM were enrolled in 15 centers. The primary endpoint was the complete response (CR) /stringent CR (sCR) rate after transplantation, and overall/progression-free survival rates were also evaluated. Following induction therapy, the overall response rate was obtained in 71% of patients, including a CR/sCR of 10% and a very good partial response (VGPR) of 26%. Twenty-six of the 42 patients completed ASCT following the protocol and CR/sCR and VGPR rate 100 days after ASCT was 26% and 17%, respectively. During consolidation therapy, 3 of the 24 patients achieved deeper responses. Eight of the 18 patients completed 2-year bortezomib maintenance without disease progression and grade 3/4 toxicities. Five patients were VGPR or partial response after ASCT but maintained response with 2-year bortezomib maintenance. Two-year overall and progression-free survival rates were 92.5% (95% confidence interval [CI]: 78.5%−97.5%) and 62.6% (95% CI: 45.8%−75.5%), respectively. Grade 3/4 toxicities (≥ 10%) included neutropenia (19%) and anemia (17%) in induction, and thrombocytopenia (29%) in consolidation. VCD induction/consolidation and bortezomib maintenance with ASCT for NDMM resulted in a high CR/sCR rate and provided good overall/progression-free survival in Japan.
doi_str_mv 10.1080/16078454.2022.2032915
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From 2013 to 2016, 42 patients with a median age of 58 (range 42-65) years with NDMM were enrolled in 15 centers. The primary endpoint was the complete response (CR) /stringent CR (sCR) rate after transplantation, and overall/progression-free survival rates were also evaluated. Following induction therapy, the overall response rate was obtained in 71% of patients, including a CR/sCR of 10% and a very good partial response (VGPR) of 26%. Twenty-six of the 42 patients completed ASCT following the protocol and CR/sCR and VGPR rate 100 days after ASCT was 26% and 17%, respectively. During consolidation therapy, 3 of the 24 patients achieved deeper responses. Eight of the 18 patients completed 2-year bortezomib maintenance without disease progression and grade 3/4 toxicities. Five patients were VGPR or partial response after ASCT but maintained response with 2-year bortezomib maintenance. Two-year overall and progression-free survival rates were 92.5% (95% confidence interval [CI]: 78.5%−97.5%) and 62.6% (95% CI: 45.8%−75.5%), respectively. Grade 3/4 toxicities (≥ 10%) included neutropenia (19%) and anemia (17%) in induction, and thrombocytopenia (29%) in consolidation. VCD induction/consolidation and bortezomib maintenance with ASCT for NDMM resulted in a high CR/sCR rate and provided good overall/progression-free survival in Japan.</description><identifier>ISSN: 1607-8454</identifier><identifier>EISSN: 1607-8454</identifier><identifier>DOI: 10.1080/16078454.2022.2032915</identifier><identifier>PMID: 35152852</identifier><language>eng</language><publisher>England: Taylor &amp; Francis</publisher><subject>Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - administration &amp; dosage ; Autografts ; autologous stem cell transplantation ; bortezomib ; Bortezomib - administration &amp; dosage ; consolidation therapy ; cyclophosphamide ; Cyclophosphamide - administration &amp; dosage ; Dexamethasone - administration &amp; dosage ; Disease-Free Survival ; Female ; Humans ; Induction Chemotherapy ; induction therapy ; Japan ; Japan - epidemiology ; maintenance therapy ; Male ; Middle Aged ; Multiple myeloma ; Multiple Myeloma - mortality ; Multiple Myeloma - therapy ; Prospective Studies ; Stem Cell Transplantation ; Survival Rate</subject><ispartof>Hematology (Luxembourg), 2022-12, Vol.27 (1), p.239-248</ispartof><rights>2022 The Author(s). 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From 2013 to 2016, 42 patients with a median age of 58 (range 42-65) years with NDMM were enrolled in 15 centers. The primary endpoint was the complete response (CR) /stringent CR (sCR) rate after transplantation, and overall/progression-free survival rates were also evaluated. Following induction therapy, the overall response rate was obtained in 71% of patients, including a CR/sCR of 10% and a very good partial response (VGPR) of 26%. Twenty-six of the 42 patients completed ASCT following the protocol and CR/sCR and VGPR rate 100 days after ASCT was 26% and 17%, respectively. During consolidation therapy, 3 of the 24 patients achieved deeper responses. Eight of the 18 patients completed 2-year bortezomib maintenance without disease progression and grade 3/4 toxicities. Five patients were VGPR or partial response after ASCT but maintained response with 2-year bortezomib maintenance. Two-year overall and progression-free survival rates were 92.5% (95% confidence interval [CI]: 78.5%−97.5%) and 62.6% (95% CI: 45.8%−75.5%), respectively. Grade 3/4 toxicities (≥ 10%) included neutropenia (19%) and anemia (17%) in induction, and thrombocytopenia (29%) in consolidation. VCD induction/consolidation and bortezomib maintenance with ASCT for NDMM resulted in a high CR/sCR rate and provided good overall/progression-free survival in Japan.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration &amp; dosage</subject><subject>Autografts</subject><subject>autologous stem cell transplantation</subject><subject>bortezomib</subject><subject>Bortezomib - administration &amp; dosage</subject><subject>consolidation therapy</subject><subject>cyclophosphamide</subject><subject>Cyclophosphamide - administration &amp; dosage</subject><subject>Dexamethasone - administration &amp; dosage</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Humans</subject><subject>Induction Chemotherapy</subject><subject>induction therapy</subject><subject>Japan</subject><subject>Japan - epidemiology</subject><subject>maintenance therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multiple myeloma</subject><subject>Multiple Myeloma - mortality</subject><subject>Multiple Myeloma - therapy</subject><subject>Prospective Studies</subject><subject>Stem Cell Transplantation</subject><subject>Survival Rate</subject><issn>1607-8454</issn><issn>1607-8454</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>0YH</sourceid><sourceid>EIF</sourceid><sourceid>DOA</sourceid><recordid>eNp9kc9u1DAQxiMEomXhEUA-cklrO3E24QRU_KlUiQucrbE93nXl2MHOql2eikesw25XPXGxPTPffDPyr6reMnrBaE8vWUfXfSvaC045L0fDByaeVedLvl4Kz5-8z6pXOd_SoqRr-rI6awQTvBf8vPr7OaYZ_8TRqVrvtY_TNuZpC6MzWBu8hxHnLeQYkLhgdnp2MVzqGHL0zsASEQiGqJMLGcGFGQMEjcTGROYEIU8ewlyjdxunPJKAd35PjINNiBkNGXd-dlMpjHv0cYQPpKyQkfBDRWNxXJwc-NfVCws-45vjvap-ff3y8-p7ffPj2_XVp5tat2s217AeGs7RImuHznStGYxoGjtgy4EqZmyPbQdMlFSjBFiuUA2D0H3X8E5b0ayq64OviXArp-RGSHsZwcl_iZg2ElJZzaNUOGhme6EaUK1oBqXaTvXQoWGqtcVxVb0_eE0p_t5hnuXoskZfPgXjLkve8b4bKKOsSMVBqlPMOaE9jWZULuDlI3i5gJdH8KXv3XHETo1oTl2PpIvg40HgQqEywl1M3sgZ9j4mWxBpl2Xz_xkP2CXDXA</recordid><startdate>20221231</startdate><enddate>20221231</enddate><creator>Muranushi, Hiroyuki</creator><creator>Kanda, Junya</creator><creator>Kobayashi, Masayuki</creator><creator>Maeda, Takeshi</creator><creator>Kitano, Toshiyuki</creator><creator>Tsuji, Masaaki</creator><creator>Ueda, Yasunori</creator><creator>Ishikawa, Takayuki</creator><creator>Nohgawa, Masaharu</creator><creator>Watanabe, Mitsumasa</creator><creator>Imada, Kazunori</creator><creator>Moriguchi, Toshinori</creator><creator>Itoh, Mitsuru</creator><creator>Ohno, Hitoshi</creator><creator>Yonezawa, Akihito</creator><creator>Hirata, Hirokazu</creator><creator>Arima, Nobuyoshi</creator><creator>Asagoe, Kohsuke</creator><creator>Anzai, Naoyuki</creator><creator>Nagata, Kayoko</creator><creator>Yasuno, Shinji</creator><creator>Kuwabara, Yoshihiro</creator><creator>Kitao, Hiromi</creator><creator>Kim, Ihhwa</creator><creator>Kawagishi, Kiyomi</creator><creator>Ueshima, Kenji</creator><creator>Tominari, Shinjiro</creator><creator>Nakayama, Takeo</creator><creator>Yamashita, Kouhei</creator><creator>Takaori-Kondo, Akifumi</creator><general>Taylor &amp; 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Yasuno, Shinji ; Kuwabara, Yoshihiro ; Kitao, Hiromi ; Kim, Ihhwa ; Kawagishi, Kiyomi ; Ueshima, Kenji ; Tominari, Shinjiro ; Nakayama, Takeo ; Yamashita, Kouhei ; Takaori-Kondo, Akifumi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c471t-a79322efe1496d64d9d533f9e42a0b1df8e46a153f93b5af2beb995c86326cf53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration &amp; dosage</topic><topic>Autografts</topic><topic>autologous stem cell transplantation</topic><topic>bortezomib</topic><topic>Bortezomib - administration &amp; dosage</topic><topic>consolidation therapy</topic><topic>cyclophosphamide</topic><topic>Cyclophosphamide - administration &amp; dosage</topic><topic>Dexamethasone - administration &amp; dosage</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Humans</topic><topic>Induction Chemotherapy</topic><topic>induction therapy</topic><topic>Japan</topic><topic>Japan - epidemiology</topic><topic>maintenance therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multiple myeloma</topic><topic>Multiple Myeloma - mortality</topic><topic>Multiple Myeloma - therapy</topic><topic>Prospective Studies</topic><topic>Stem Cell Transplantation</topic><topic>Survival Rate</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Muranushi, Hiroyuki</creatorcontrib><creatorcontrib>Kanda, Junya</creatorcontrib><creatorcontrib>Kobayashi, Masayuki</creatorcontrib><creatorcontrib>Maeda, Takeshi</creatorcontrib><creatorcontrib>Kitano, Toshiyuki</creatorcontrib><creatorcontrib>Tsuji, Masaaki</creatorcontrib><creatorcontrib>Ueda, Yasunori</creatorcontrib><creatorcontrib>Ishikawa, Takayuki</creatorcontrib><creatorcontrib>Nohgawa, Masaharu</creatorcontrib><creatorcontrib>Watanabe, Mitsumasa</creatorcontrib><creatorcontrib>Imada, Kazunori</creatorcontrib><creatorcontrib>Moriguchi, Toshinori</creatorcontrib><creatorcontrib>Itoh, Mitsuru</creatorcontrib><creatorcontrib>Ohno, Hitoshi</creatorcontrib><creatorcontrib>Yonezawa, Akihito</creatorcontrib><creatorcontrib>Hirata, Hirokazu</creatorcontrib><creatorcontrib>Arima, Nobuyoshi</creatorcontrib><creatorcontrib>Asagoe, Kohsuke</creatorcontrib><creatorcontrib>Anzai, Naoyuki</creatorcontrib><creatorcontrib>Nagata, Kayoko</creatorcontrib><creatorcontrib>Yasuno, Shinji</creatorcontrib><creatorcontrib>Kuwabara, Yoshihiro</creatorcontrib><creatorcontrib>Kitao, Hiromi</creatorcontrib><creatorcontrib>Kim, Ihhwa</creatorcontrib><creatorcontrib>Kawagishi, Kiyomi</creatorcontrib><creatorcontrib>Ueshima, Kenji</creatorcontrib><creatorcontrib>Tominari, Shinjiro</creatorcontrib><creatorcontrib>Nakayama, Takeo</creatorcontrib><creatorcontrib>Yamashita, Kouhei</creatorcontrib><creatorcontrib>Takaori-Kondo, Akifumi</creatorcontrib><collection>Taylor &amp; Francis Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Hematology (Luxembourg)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Muranushi, Hiroyuki</au><au>Kanda, Junya</au><au>Kobayashi, Masayuki</au><au>Maeda, Takeshi</au><au>Kitano, Toshiyuki</au><au>Tsuji, Masaaki</au><au>Ueda, Yasunori</au><au>Ishikawa, Takayuki</au><au>Nohgawa, Masaharu</au><au>Watanabe, Mitsumasa</au><au>Imada, Kazunori</au><au>Moriguchi, Toshinori</au><au>Itoh, Mitsuru</au><au>Ohno, Hitoshi</au><au>Yonezawa, Akihito</au><au>Hirata, Hirokazu</au><au>Arima, Nobuyoshi</au><au>Asagoe, Kohsuke</au><au>Anzai, Naoyuki</au><au>Nagata, Kayoko</au><au>Yasuno, Shinji</au><au>Kuwabara, Yoshihiro</au><au>Kitao, Hiromi</au><au>Kim, Ihhwa</au><au>Kawagishi, Kiyomi</au><au>Ueshima, Kenji</au><au>Tominari, Shinjiro</au><au>Nakayama, Takeo</au><au>Yamashita, Kouhei</au><au>Takaori-Kondo, Akifumi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial</atitle><jtitle>Hematology (Luxembourg)</jtitle><addtitle>Hematology</addtitle><date>2022-12-31</date><risdate>2022</risdate><volume>27</volume><issue>1</issue><spage>239</spage><epage>248</epage><pages>239-248</pages><issn>1607-8454</issn><eissn>1607-8454</eissn><abstract>We conducted a phase II trial to prospectively evaluate the efficacy and safety of bortezomib-cyclophosphamide-dexamethasone (VCD) induction, autologous stem cell transplantation (ASCT), VCD consolidation, and bortezomib maintenance in transplant-eligible newly diagnosed multiple myeloma (NDMM) patients in Japan (UMIN000010542). From 2013 to 2016, 42 patients with a median age of 58 (range 42-65) years with NDMM were enrolled in 15 centers. The primary endpoint was the complete response (CR) /stringent CR (sCR) rate after transplantation, and overall/progression-free survival rates were also evaluated. Following induction therapy, the overall response rate was obtained in 71% of patients, including a CR/sCR of 10% and a very good partial response (VGPR) of 26%. Twenty-six of the 42 patients completed ASCT following the protocol and CR/sCR and VGPR rate 100 days after ASCT was 26% and 17%, respectively. During consolidation therapy, 3 of the 24 patients achieved deeper responses. Eight of the 18 patients completed 2-year bortezomib maintenance without disease progression and grade 3/4 toxicities. Five patients were VGPR or partial response after ASCT but maintained response with 2-year bortezomib maintenance. Two-year overall and progression-free survival rates were 92.5% (95% confidence interval [CI]: 78.5%−97.5%) and 62.6% (95% CI: 45.8%−75.5%), respectively. Grade 3/4 toxicities (≥ 10%) included neutropenia (19%) and anemia (17%) in induction, and thrombocytopenia (29%) in consolidation. VCD induction/consolidation and bortezomib maintenance with ASCT for NDMM resulted in a high CR/sCR rate and provided good overall/progression-free survival in Japan.</abstract><cop>England</cop><pub>Taylor &amp; Francis</pub><pmid>35152852</pmid><doi>10.1080/16078454.2022.2032915</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-4348-4450</orcidid><orcidid>https://orcid.org/0000-0002-7918-6252</orcidid><oa>free_for_read</oa></addata></record>
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identifier ISSN: 1607-8454
ispartof Hematology (Luxembourg), 2022-12, Vol.27 (1), p.239-248
issn 1607-8454
1607-8454
language eng
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source Taylor & Francis Open Access; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
subjects Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Autografts
autologous stem cell transplantation
bortezomib
Bortezomib - administration & dosage
consolidation therapy
cyclophosphamide
Cyclophosphamide - administration & dosage
Dexamethasone - administration & dosage
Disease-Free Survival
Female
Humans
Induction Chemotherapy
induction therapy
Japan
Japan - epidemiology
maintenance therapy
Male
Middle Aged
Multiple myeloma
Multiple Myeloma - mortality
Multiple Myeloma - therapy
Prospective Studies
Stem Cell Transplantation
Survival Rate
title Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial
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