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2. Plasma cell leukemia: consensus statement on diagnostic requirements, response criteria and treatment recommendations by the International Myeloma Working Group

Author

Fernández de Larrea, C, Kyle, R A, Durie, B G M, Ludwig, H, Usmani, S, Vesole, D H, Hajek, R, San Miguel, J F, Sezer, O, Sonneveld, P, Kumar, S K, Mahindra, A, Comenzo, R, Palumbo, A, Mazumber, A, Anderson, K C, Richardson, P G, Badros, A Z, Caers, J, Cavo, M, LeLeu, X, Dimopoulos, M A, Chim, C S, Schots, R, Noeul, A, Fantl, D, Mellqvist, U-H, Landgren, O, Chanan-Khan, A, Moreau, P, Fonseca, R, Merlini, G, Lahuerta, J J, Bladé, J, Orlowski, R Z, and Shah, J J

Published
2013
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3. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

Author

Meletios A Dimopoulos, Francesca Gay, Fredrik Schjesvold, Meral Beksac, Roman Hajek, Katja Christina Weisel, Hartmut Goldschmidt, Vladimir Maisnar, Philippe Moreau, Chang Ki Min, Agnieszka Pluta, Wee-Joo Chng, Martin Kaiser, Sonja Zweegman, Maria-Victoria Mateos, Andrew Spencer, Shinsuke Iida, Gareth Morgan, Kaveri Suryanarayan, Zhaoyang Teng, Tomas Skacel, Antonio Palumbo, Ajeeta B Dash, Neeraj Gupta, Richard Labotka, S Vincent Rajkumar, Daniel Bar, Alfredo Basso, Dorotea Fantl, Simon He, Neomi Horvath, Cindy Lee, Phillip Rowlings, Kerry Taylor, Tara Cochrane, Fiona Kwok, Sundreswran Ramanathan, Hermine Agis, Niklas Zojer, Alain Kentos, Fritz Offner, Jan Van Droogenbroeck, Ka Lung Wu, Angelo Maiolino, Gracia Martinez, Karla Zanella, Marcelo Capra, Sérgio Araújo, Evzen Gregora, Ludek Pour, Vlastimil Scudla, Ivan Spicka, Niels Abildgaard, Niels Andersen, Bo Amdi Jensen, Carsten Helleberg, Torben Plesner, Morten Salomo, Asta Svirskaite, Richard Delarue, Igor Blau, Aneta Schieferdecker, Veronica Teleanu, Markus Munder, Christoph Röllig, Han-Juergen Salwender, Stephan Fuhrmann, Katja Weisel, Jan Duerig, Matthias Zeis, Stefan Klein, Peter Reimer, Christian Schmidt, Christof Scheid, Karin Mayer, Martin Hoffmann, Markus Sosada, Athanasios Dimopoulos, Sosana Delimpasi, Mary-Christine Kyrtsonis, Achilleas Anagnostopoulos, Zsolt Nagy, Árpád Illés, Miklós Egyed, Zita Borbényi, Gabor Mikala, Najib Dally, Netanel Horowitz, Odit Gutwein, Anatoly Nemets, Iuliana Vaxman, Olga Shvetz, Svetlana Trestman, Rosa Ruchlemer, Arnon Nagler, Tamar Tadmor, Ory Rouvio, Meir Preis, Michele Cavo, Luca De Rosa, Pellegrino Musto, Anna Cafro, Patrizia Tosi, Massimo Offidani, Alessandro Corso, Giuseppe Rossi, Anna Marina Liberati, Alberto Bosi, Kenshi Suzuki, Chiaki Nakaseko, Takayuki Ishikawa, Morio Matsumoto, Hirokazu Nagai, Kazutaka Sunami, Takaaki Chou, Koichi Akashi, Naoki Takezako, Shotaro Hagiwara, Hyeon Seok Eom, Deog-Yeon Jo, Jin Seok Kim, Jae Hoon Lee, Sung Soo Yoon, Dok Hyun Yoon, Kihyun Kim, Mark-David Levin, Edo Vellenga, Monique Minnema, Anders Waage, Einar Haukås, Sebastian Grosicki, Andrzej Pluta, Tadeusz Robak, Herlander Marques, Rui Bergantim, Fernando Campilho, Wee Joo Chng, Yeow Tee Goh, Andrew McDonald, Bernado Rapoport, Miguel Angel Álvarez Rivas, Felipe De Arriba de La Fuente, Yolanda González Montes, Jesus Martin Sanchez, Maria Victoria Mateos, Albert Oriol Rocafiguera, Laura Rosinol, Jesús San Miguel, Jaime Pérez de Oteyza, Cristina Encinas, Adrian Alegre-Amor, Ana López-Guía, Per Axelsson, Kristina Carlson, Olga Stromberg, Markus Hansson, Cecile Hveding Blimark, Rouven Mueller, Chih-Cheng Chen, Ta-Chih Liu, Shang-Yi Huang, Po-Nan Wang, Thanyaphong Na Nakorn, Kannadit Prayongratana, Ali Unal, Hakan Goker, Mehmet Sonmez, Sybiryna Korenkova, Aristeidis Chaidos, Heather Oakervee, Hamdi Sati, Reuben Benjamin, Ashutosh Wechalekar, Mamta Garg, Karthik Ramasamy, Gordon Cook, Andrew Chantry, Matthew Jenner, Francis Buadi, Robert Berryman, Murali Janakiram, Takeda Pharmaceutical Company, Dimopoulos MA1, Gay F2, Schjesvold F3, Beksac M4, Hajek R5, Weisel KC6, Goldschmidt H7, Maisnar V8, Moreau P9, Min CK10, Pluta A11, Chng WJ12, Kaiser M13, Zweegman S14, Mateos MV15, Spencer A16, Iida S17, Morgan G18, Suryanarayan K19, Teng Z19, Skacel T19, Palumbo A20, Dash AB19, Gupta N19, Labotka R19, Rajkumar SV21, TOURMALINE-MM3 study group. Bar D, Basso A, Fantl D, He S, Horvath N, Lee C, Rowlings P, Taylor K, Spencer A, Cochrane T, Kwok F, Ramanathan S, Agis H, Zojer N, Kentos A, Offner F, Van Droogenbroeck J, Wu KL, Maiolino A, Martinez G, Zanella K, Capra M, Araújo S, Gregora E, Hajek R, Maisnar V, Pour L, Scudla V, Spicka I, Abildgaard N, Andersen N, Jensen BA, Helleberg C, Plesner T, Salomo M, Svirskaite A, Delarue R, Moreau P, Blau I, Goldschmidt H, Schieferdecker A, Teleanu V, Munder M, Röllig C, Salwender HJ, Fuhrmann S, Weisel K, Duerig J, Zeis M, Klein S, Reimer P, Schmidt C, Scheid C, Mayer K, Hoffmann M, Sosada M, Dimopoulos A, Delimpasi S, Kyrtsonis MC, Anagnostopoulos A, Nagy Z, Illés Á, Egyed M, Borbényi Z, Mikala G, Dally N, Horowitz N, Gutwein O, Nemets A, Vaxman I, Shvetz O, Trestman S, Ruchlemer R, Nagler A, Tadmor T, Rouvio O, Preis M, Gay F, Cavo M, De Rosa L, Musto P, Cafro A, Tosi P, Offidani M, Corso A, Rossi G, Liberati AM, Bosi A, Suzuki K, Iida S, Nakaseko C, Ishikawa T, Matsumoto M, Nagai H, Sunami K, Chou T, Akashi K, Takezako N, Hagiwara S, Eom HS, Jo DY, Kim JS, Lee JH, Min CK, Yoon SS, Yoon DH, Kim K, Zweegman S, Levin MD, Vellenga E, Minnema M, Schjesvold F, Waage A, Haukås E, Grosicki S, Pluta A, Robak T, Marques H, Bergantim R, Campilho F, Chng WJ, Goh YT, McDonald A, Rapoport B, Álvarez Rivas MA, De Arriba de La Fuente F, González Montes Y, Martin Sanchez J, Mateos MV, Oriol Rocafiguera A, Rosinol L, San Miguel J, Pérez de Oteyza J, Encinas C, Alegre-Amor A, López-Guía A, Axelsson P, Carlson K, Stromberg O, Hansson M, Hveding Blimark C, Mueller R, Chen CC, Liu TC, Huang SY, Wang PN, Na Nakorn T, Prayongratana K, Beksac M, Unal A, Goker H, Sonmez M, Korenkova S, Chaidos A, Oakervee H, Sati H, Benjamin R, Wechalekar A, Garg M, Kaiser M, Ramasamy K, Cook G, Chantry A, Jenner M, Buadi F, Berryman R, Janakiram M., Guided Treatment in Optimal Selected Cancer Patients (GUTS), Stem Cell Aging Leukemia and Lymphoma (SALL), CCA - Cancer Treatment and quality of life, CCA - Imaging and biomarkers, CCA - Cancer biology and immunology, and Hematology

Subjects
Male, Time Factors, DIAGNOSED MULTIPLE-MYELOMA, Clinical Trial, Phase III, Administration, Oral, 030204 cardiovascular system & hematology, Ixazomib, chemistry.chemical_compound, 0302 clinical medicine, Autologous stem-cell transplantation, Maintenance therapy, Clinical endpoint, 030212 general & internal medicine, Non-U.S. Gov't, Boron Compounds/administration & dosage, IMPROVES SURVIVAL, INDUCTION, Research Support, Non-U.S. Gov't, General Medicine, CHEMOTHERAPY, Middle Aged, Clinical Trial, DEXAMETHASONE, Antineoplastic Agents/administration & dosage, Multicenter Study, Treatment Outcome, Administration, Randomized Controlled Trial, Disease Progression, Female, Multiple Myeloma, Autologous, Boron Compounds, Oral, medicine.medical_specialty, Glycine, Multiple Myeloma/drug therapy, BORTEZOMIB, Antineoplastic Agents, Placebo, Research Support, Transplantation, Autologous, 03 medical and health sciences, Phase III, Double-Blind Method, Internal medicine, medicine, Journal Article, Humans, THALIDOMIDE, Transplantation, business.industry, Clinical trial, LENALIDOMIDE MAINTENANCE, Regimen, chemistry, autologous stem cell transplantation, multiple myeloma, Ixazomib, business, HIGH-DOSE THERAPY, Glycine/administration & dosage, Stem Cell Transplantation
Abstract

[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. [Methods]: The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study took place in 167 clinical or hospital sites in 30 countries in Europe, the Middle East, Africa, Asia, and North and South America. Eligible participants were adults with a confirmed diagnosis of symptomatic multiple myeloma according to International Myeloma Working Group criteria who had achieved at least a partial response after undergoing standard-of-care induction therapy followed by high-dose melphalan (200 mg/m²) conditioning and single ASCT within 12 months of diagnosis. Patients were randomly assigned in a 3:2 ratio to oral ixazomib or matching placebo on days 1, 8, and 15 in 28-day cycles for 2 years following induction, high-dose therapy, and transplantation. The initial 3 mg dose was increased to 4 mg from cycle 5 if tolerated during cycles 1–4. Randomisation was stratified by induction regimen, pre-induction disease stage, and response post-transplantation. The primary endpoint was progression-free survival (PFS) by intention-to-treat analysis. Safety was assessed in all patients who received at least one dose of ixazomib or placebo, according to treatment actually received. This trial is registered with ClinicalTrials.gov, number NCT02181413, and follow-up is ongoing. [Findings]: Between July 31, 2014, and March 14, 2016, 656 patients were enrolled and randomly assigned to receive ixazomib maintenance therapy (n=395) or placebo (n=261). With a median follow-up of 31 months (IQR 27·3–35·7), we observed a 28% reduction in the risk of progression or death with ixazomib versus placebo (median PFS 26·5 months [95% CI 23·7–33·8] vs 21·3 months [18·0–24·7]; hazard ratio 0·72, 95% CI 0·58–0·89; p=0·0023). No increase in second malignancies was noted with ixazomib therapy (12 [3%] patients) compared with placebo (eight [3%] patients) at the time of this analysis. 108 (27%) of 394 patients in the ixazomib group and 51 (20%) of 259 patients in the placebo group experienced serious adverse events. During the treatment period, one patient died in the ixazomib group and none died in the placebo group. [Interpretation]: Ixazomib maintenance prolongs PFS and represents an additional option for post-transplant maintenance therapy in patients with newly diagnosed multiple myeloma, This study was sponsored by Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company.

Published
2019

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