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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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 |
format | Article |
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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 & Francis</publisher><subject>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</subject><ispartof>Hematology (Luxembourg), 2022-12, Vol.27 (1), p.239-248</ispartof><rights>2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c471t-a79322efe1496d64d9d533f9e42a0b1df8e46a153f93b5af2beb995c86326cf53</cites><orcidid>0000-0002-4348-4450 ; 0000-0002-7918-6252</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.tandfonline.com/doi/pdf/10.1080/16078454.2022.2032915$$EPDF$$P50$$Ginformaworld$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.tandfonline.com/doi/full/10.1080/16078454.2022.2032915$$EHTML$$P50$$Ginformaworld$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,860,2096,27479,27901,27902,59116,59117</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35152852$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><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><title>Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial</title><title>Hematology (Luxembourg)</title><addtitle>Hematology</addtitle><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.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Autografts</subject><subject>autologous stem cell transplantation</subject><subject>bortezomib</subject><subject>Bortezomib - administration & dosage</subject><subject>consolidation therapy</subject><subject>cyclophosphamide</subject><subject>Cyclophosphamide - administration & dosage</subject><subject>Dexamethasone - administration & 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 & Francis</general><general>Taylor & Francis Group</general><scope>0YH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-4348-4450</orcidid><orcidid>https://orcid.org/0000-0002-7918-6252</orcidid></search><sort><creationdate>20221231</creationdate><title>Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial</title><author>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</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 - 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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.</abstract><cop>England</cop><pub>Taylor & 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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recordid | cdi_pubmed_primary_35152852 |
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 |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-12T17%3A43%3A48IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Bortezomib-cyclophosphamide-dexamethasone%20induction/consolidation%20and%20bortezomib%20maintenance%20for%20transplant-eligible%20newly%20diagnosed%20multiple%20myeloma:%20phase%202%20multicenter%20trial&rft.jtitle=Hematology%20(Luxembourg)&rft.au=Muranushi,%20Hiroyuki&rft.date=2022-12-31&rft.volume=27&rft.issue=1&rft.spage=239&rft.epage=248&rft.pages=239-248&rft.issn=1607-8454&rft.eissn=1607-8454&rft_id=info:doi/10.1080/16078454.2022.2032915&rft_dat=%3Cproquest_pubme%3E2628690101%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2628690101&rft_id=info:pmid/35152852&rft_doaj_id=oai_doaj_org_article_be9c1f85b3ab4539bb46b8a6ed1b4f86&rfr_iscdi=true |