Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

Dimopoulos Meletios A.; Gay Francesca; Schjesvold Fredrik; Beksac Meral; Hajek Roman; Weisel Katja Christina; Goldschmidt Hartmut; Maisnar Vladimir; Moreau Philippe; Min Chang Ki; Pluta Agnieszka; Chng Wee-Joo; Kaiser Martin; Zweegman Sonja; Mateos Maria-Victoria; Spencer Andrew; Iida Shinsuke; Morgan Gareth; Suryanarayan Kaveri; Teng Zhaoyang; Skacel Tomas; Palumbo Antonio; Dash Ajeeta B.; Gupta Neeraj; Labotka Richard; Rajkumar S. Vincent; Bar Daniel; Basso Alfredo; Fantl Dorotea; He Simon; Horvath Neomi; Lee Cindy; Rowlings Phillip; Taylor Kerry; Cochrane Tara; Kwok Fiona; Ramanathan Sundreswran; Agis Hermine; Zojer Niklas; Kentos Alain; Offner Fritz; Van Droogenbroeck Jan; Wu Ka Lung; Maiolino Angelo; Martinez Gracia; Zanella Karla; Capra Marcelo; Araujo Sergio; Gregora Evzen; Pour Ludek; Scudla Vlastimil; Spicka Ivan; Abildgaard Niels; Andersen Niels; Jensen Bo Amdi; Helleberg Carsten; Plesner Torben; Salomo Morten; Svirskaite Asta; Delarue Richard; Blau Igor; Schieferdecker Aneta; Teleanu Veronica; Munder Markus; Rollig Christoph; Salwender Han-Juergen; Fuhrmann Stephan; Weisel Katja; Duerig Jan; Zeis Matthias; Klein Stefan; Reimer Peter; Schmidt Christian; Scheid Christof; Mayer Karin; Hoffmann Martin; Sosada Markus; Dimopoulos Athanasios; Delimpasi Sosana; Kyrtsonis Mary-Christine; Anagnostopoulos Achilleas; Nagy Zsolt; Illes Arpad; Egyed Miklos; Borbenyi Zita; Mikala Gabor; Dally Najib; Horowitz Netanel; Gutwein Odit; Nemets Anatoly; Vaxman Iuliana; Shvetz Olga; Trestman Svetlana; Ruchlemer Rosa; Nagler Arnon; Tadmor Tamar; Rouvio Ory; Preis Meir; Cavo Michele; De Rosa Luca; Musto Pellegrino; Cafro Anna; Tosi Patrizia; Offidani Massimo; Corso Alessandro; Rossi Giuseppe; Liberati Anna Marina; Bosi Alberto; Suzuki Kenshi; Nakaseko Chiaki; Ishikawa Takayuki; Matsumoto Morio; Nagai Hirokazu; Sunami Kazutaka; Chou Takaaki; Akashi Koichi; Takezako Naoki; Hagiwara Shotaro; Eom Hyeon Seok; Jo Deog-Yeon; Kim Jin Seok; Lee Jae Hoon; Yoon Sung Soo; Yoon Dok Hyun; Kim Kihyun; Levin Mark-David; Vellenga Edo; Minnema Monique; Waage Anders; Haukas Einar; Grosicki Sebastian; Pluta Andrzej; Robak Tadeusz; Marques Herlander; Bergantim Rui; Campilho Fernando; Chng Wee Joo; Goh Yeow Tee; McDonald Andrew; Rapoport Bernado; Rivas Miguel Angel Alvarez; de La Fuente Felipe De Arriba; Montes Yolanda Gonzalez; Sanchez Jesus Martin; Mateos Maria Victoria; Rocafiguera Albert Oriol; Rosinol Laura; San Miguel Jesus; de Oteyza Jaime Perez; Encinas Cristina; Alegre-Amor Adrian; Lopez-Guia Ana; Axelsson Per; Carlson Kristina; Stromberg Olga; Hansson Markus; Blimark Cecile Hveding; Mueller Rouven; Chen Chih-Cheng; Liu Ta-Chih; Huang Shang-Yi; Wang Po-Nan; Nakorn Thanyaphong Na; Prayongratana Kannadit; Unal Ali; Goker Hakan; Sonmez Mehmet; Korenkova Sybiryna; Chaidos Aristeidis; Oakervee Heather; Sati Hamdi; Benjamin Reuben; Wechalekar Ashutosh; Garg Mamta; Ramasamy Karthik; Cook Gordon; Chantry Andrew; Jenner Matthew; Buadi Francis; Berryman Robert; Janakiram Murali

首页> 外文期刊>The Lancet >Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

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Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

机译：在自体干细胞移植后的口服Ixazomib维持（Tourmaline-MM3）：双盲，随机，安慰剂控制第3阶段试验

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Background Maintenance therapy following autologous stem cell transplantation (ASCT) can delay disease progression and prolong survival in patients with multiple myeloma. Ixazomib is ideally suited for maintenance therapy given its convenient once-weekly oral dosing and low toxicity profile. In this study, we aimed to determine the safety and efficacy of ixazomib as maintenance therapy following ASCT.

机译：背景技术在自体干细胞移植（ASCT）后维护治疗可以延迟多种骨髓瘤患者的疾病进展和延长存活。 Ixazomib非常适合维持治疗，鉴于其综合性每周口服给药和低毒性剖面。在本研究中，我们旨在确定Ixazomib作为维护治疗的安全性和有效性。

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《The Lancet》 |2019年第10168期|共12页
作者
Dimopoulos Meletios A.; Gay Francesca; Schjesvold Fredrik; Beksac Meral; Hajek Roman; Weisel Katja Christina; Goldschmidt Hartmut; Maisnar Vladimir; Moreau Philippe; Min Chang Ki; Pluta Agnieszka; Chng Wee-Joo; Kaiser Martin; Zweegman Sonja; Mateos Maria-Victoria; Spencer Andrew; Iida Shinsuke; Morgan Gareth; Suryanarayan Kaveri; Teng Zhaoyang; Skacel Tomas; Palumbo Antonio; Dash Ajeeta B.; Gupta Neeraj; Labotka Richard; Rajkumar S. Vincent; Bar Daniel; Basso Alfredo; Fantl Dorotea; He Simon; Horvath Neomi; Lee Cindy; Rowlings Phillip; Taylor Kerry; Cochrane Tara; Kwok Fiona; Ramanathan Sundreswran; Agis Hermine; Zojer Niklas; Kentos Alain; Offner Fritz; Van Droogenbroeck Jan; Wu Ka Lung; Maiolino Angelo; Martinez Gracia; Zanella Karla; Capra Marcelo; Araujo Sergio; Gregora Evzen; Pour Ludek; Scudla Vlastimil; Spicka Ivan; Abildgaard Niels; Andersen Niels; Jensen Bo Amdi; Helleberg Carsten; Plesner Torben; Salomo Morten; Svirskaite Asta; Delarue Richard; Blau Igor; Schieferdecker Aneta; Teleanu Veronica; Munder Markus; Rollig Christoph; Salwender Han-Juergen; Fuhrmann Stephan; Weisel Katja; Duerig Jan; Zeis Matthias; Klein Stefan; Reimer Peter; Schmidt Christian; Scheid Christof; Mayer Karin; Hoffmann Martin; Sosada Markus; Dimopoulos Athanasios; Delimpasi Sosana; Kyrtsonis Mary-Christine; Anagnostopoulos Achilleas; Nagy Zsolt; Illes Arpad; Egyed Miklos; Borbenyi Zita; Mikala Gabor; Dally Najib; Horowitz Netanel; Gutwein Odit; Nemets Anatoly; Vaxman Iuliana; Shvetz Olga; Trestman Svetlana; Ruchlemer Rosa; Nagler Arnon; Tadmor Tamar; Rouvio Ory; Preis Meir; Cavo Michele; De Rosa Luca; Musto Pellegrino; Cafro Anna; Tosi Patrizia; Offidani Massimo; Corso Alessandro; Rossi Giuseppe; Liberati Anna Marina; Bosi Alberto; Suzuki Kenshi; Nakaseko Chiaki; Ishikawa Takayuki; Matsumoto Morio; Nagai Hirokazu; Sunami Kazutaka; Chou Takaaki; Akashi Koichi; Takezako Naoki; Hagiwara Shotaro; Eom Hyeon Seok; Jo Deog-Yeon; Kim Jin Seok; Lee Jae Hoon; Yoon Sung Soo; Yoon Dok Hyun; Kim Kihyun; Levin Mark-David; Vellenga Edo; Minnema Monique; Waage Anders; Haukas Einar; Grosicki Sebastian; Pluta Andrzej; Robak Tadeusz; Marques Herlander; Bergantim Rui; Campilho Fernando; Chng Wee Joo; Goh Yeow Tee; McDonald Andrew; Rapoport Bernado; Rivas Miguel Angel Alvarez; de La Fuente Felipe De Arriba; Montes Yolanda Gonzalez; Sanchez Jesus Martin; Mateos Maria Victoria; Rocafiguera Albert Oriol; Rosinol Laura; San Miguel Jesus; de Oteyza Jaime Perez; Encinas Cristina; Alegre-Amor Adrian; Lopez-Guia Ana; Axelsson Per; Carlson Kristina; Stromberg Olga; Hansson Markus; Blimark Cecile Hveding; Mueller Rouven; Chen Chih-Cheng; Liu Ta-Chih; Huang Shang-Yi; Wang Po-Nan; Nakorn Thanyaphong Na; Prayongratana Kannadit; Unal Ali; Goker Hakan; Sonmez Mehmet; Korenkova Sybiryna; Chaidos Aristeidis; Oakervee Heather; Sati Hamdi; Benjamin Reuben; Wechalekar Ashutosh; Garg Mamta; Ramasamy Karthik; Cook Gordon; Chantry Andrew; Jenner Matthew; Buadi Francis; Berryman Robert; Janakiram Murali;
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作者单位

Univ Athens Sch Med Hematol &

Med Oncol Dept Clin Therapeut Athens Greece;

Azienda Osped Univ City Hlth &

Sci Turin Dept Oncol &

Hematol Turin Italy;

Oslo Univ Hosp Oslo Myeloma Ctr Oslo Norway;

Ankara Univ Dept Hematol Ankara Turkey;

Univ Hosp Ostrava Dept Hematooncol Ostrava Czech Republic;

Univ Tubingen Dept Internal Med 2 Tubingen Germany;

Heidelberg Univ Dept Internal Med 5 Univ Med Hosp Heidelberg Germany;

FN &

LF UK Hradec Kralove Dept Med Hematol 4 Hradec Kralove Czech Republic;

Univ Nantes Univ Hosp Hotel Dieu Dept Hematol Nantes France;

Seoul St Marys Hosp Dept Internal Med Seoul South Korea;

Med Univ Lodz Dept Haematol Multidisciplinary Prov Ctr Traumatol &

Oncol Nico Lodz Poland;

Natl Univ Hlth Syst Dept Haematol Oncol Natl Univ Canc Inst Singapore Singapore;

Royal Marsden Hosp Dept Haematol London England;

Vrije Univ Amsterdam Amsterdam Univ Med Ctr Dept Hematol Canc Ctr Amsterdam Amsterdam;

Univ Hosp Salamanca Dept Hematol CIC IBMCC Salamanca Spain;

Alfred Hlth Monash Univ Malignant Haematol &

Stem Cell Transplantat Serv Melbourne Vic Australia;

Nagoya City Univ Dept Hematol &

Oncol Grad Sch Med Sci Nagoya Aichi Japan;

Univ Arkansas Med Sci Myeloma Inst Little Rock AR 72205 USA;

Millennium Pharmaceut Inc Cambridge MA USA;

Millennium Pharmaceut Inc Cambridge MA USA;

Millennium Pharmaceut Inc Cambridge MA USA;

Millennium Pharmaceut Inc Cambridge MA USA;

Millennium Pharmaceut Inc Cambridge MA USA;

Millennium Pharmaceut Inc Cambridge MA USA;

Millennium Pharmaceut Inc Cambridge MA USA;

Mayo Clin Div Hematol Dept Internal Med Rochester MN USA;

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专利

1. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial [J] . Dimopoulos Meletios A., Gay Francesca, Schjesvold Fredrik, The Lancet . 2019,第10168期

机译：在自体干细胞移植后的口服Ixazomib维持（Tourmaline-MM3）：双盲，随机，安慰剂控制第3阶段试验
2. The role of ixazomib as an augmented conditioning therapy in salvage autologous stem cell transplant (ASCT) and as a post-ASCT consolidation and maintenance strategy in patients with relapsed multiple myeloma (ACCoRd [UK-MRA Myeloma XII] trial): study protocol for a Phase III randomised controlled trial [J] . Alina Striha, A. John Ashcroft, Anna Hockaday, Trials . 2018,第1期

机译：ixazomib在复发性多发性骨髓瘤患者中作为挽救性自体干细胞移植（ASCT）的增强条件疗法以及ASCT后巩固和维持策略的作用（ACCoRd [UK-MRA Myeloma XII]试验）： III期随机对照试验
3. Ixazomib-thalidomide-low dose dexamethasone induction followed by maintenance therapy with ixazomib or placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation; results from the randomized phase II HOVON-126/NMSG 21.13 trial [J] . Sonja Zweegman, Claudia A.M. Stege, Einar Haukas, Haematologica . 2020,第12期

机译：IXAZOMIB-羟胺胺 - 低剂量地塞米松诱导随后与新诊断的多发性骨髓瘤患者的IXAZOMIB或安慰剂进行维持治疗，没有资格获得自体干细胞移植;随机阶段II Hovon-126 / NMSG的结果结果来自21.13试验
4. Phase 1 Trial of Retroviral-Mediated Transfer of the Human MDR-1 In Patients Undergoing High-Dose Chemotherapy and Autologous Stem Cell Transplantation [C] . Charles Hesdorffer, Janet Ayello, Maureen Ward, Keio International Symposium for Life Sciences and Medicine . 2000

机译：逆转录病毒介导的人MDR-1转移的第1期试验在接受高剂量化疗和自体干细胞移植的患者中
5. A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial of Fish Oil (Eicosapentaenoic Acid and Docosahexaenoic Acid) on Lung and Systemic Inflammation in Patients with Acute Lung Injury. [D] . Stapleton, Renee Doney. 2010

机译：鱼油（二十碳五烯酸和二十二碳六烯酸）对急性肺损伤患者的肺和全身炎症的II期，随机，双盲，安慰剂对照试验。
6. The role of ixazomib as an augmented conditioning therapy in salvage autologous stem cell transplant (ASCT) and as a post-ASCT consolidation and maintenance strategy in patients with relapsed multiple myeloma (ACCoRd UK-MRA Myeloma XII trial): study protocol for a Phase III randomised controlled trial [O] . Alina Striha, A. John Ashcroft, Anna Hockaday, 2018

机译：ixazomib在复发性多发性骨髓瘤患者中作为挽救性自体干细胞移植（ASCT）的增强条件疗法以及ASCT后巩固和维持策略的作用（ACCoRd UK-MRA Myeloma XII试验）： III期随机对照试验
7. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial [O] . Meletios A Dimopoulos, Francesca Gay, Fredrik Schjesvold, 2019

机译：在自体干细胞移植后的口服Ixazomib维持（Tourmaline-MM3）：双盲，随机，安慰剂控制第3阶段试验

Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

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