Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma.
Maria-Victoria Mateos,Meletios A. Dimopoulos,Michele Cavo,Kenshi Suzuki,Andrzej Jakubowiak,Stefan Knop,Chantal Doyen,Paulo Sérgio Lucio,Zsolt Nagy,Polina Kaplan,Ludek Pour,Mark Cook,Sebastian Grosicki,Andre Crepaldi,Anna Marina Liberati,Philip Campbell,Tatiana Shelekhova,Sung-Soo Yoon,Genadi Iosava,Tomoaki Fujisaki,Mamta Garg,Christopher Chiu,Jianping Wang,Robin Carson,Wendy Crist,William Deraedt,Huong Nguyen,Ming Qi,Jesús F. San-Miguel +28 more
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TLDR
Among patients with newly diagnosed multiple myeloma who were ineligible for stem‐cell transplantation, daratumumab combined with bortezomib, melphalan, and prednisone resulted in a lower risk of disease progression or death than the same regimen without darumumab.Abstract:
Background The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma. Methods In this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression. The primary end point was progression-free survival. Results At a median follow-up of 16.5 months in a prespecified interim analysis, the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death,...read more
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Journal ArticleDOI
Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study
Philippe Moreau,Michel Attal,Cyrille Hulin,Bertrand Arnulf,Karim Belhadj,Lotfi Benboubker,Marie C. Béné,Annemiek Broijl,Hélène Caillon,Denis Caillot,Jill Corre,Michel Delforge,Thomas Dejoie,Chantal Doyen,Thierry Facon,Cécile Sonntag,Jean Fontan,Laurent Garderet,Kon-Siong Jie,Lionel Karlin,Frédérique Kuhnowski,Jérôme J. Lambert,Xavier Leleu,Pascal Lenain,Margaret Macro,Claire Mathiot,Frédérique Orsini-Piocelle,Aurore Perrot,Anne-Marie Stoppa,Niels W.C.J. van de Donk,Soraya Wuilleme,Sonja Zweegman,Brigitte Kolb,Cyrille Touzeau,Murielle Roussel,Mourad Tiab,Jean-Pierre Marolleau,Nathalie Meuleman,Marie-Christiane Vekemans,Matthijs Westerman,Saskia K. Klein,Mark-David Levin,Jean Paul Fermand,Martine Escoffre-Barbe,Jean-Richard Eveillard,Reda Garidi,Tahamtan Ahmadi,Sen Zhuang,Christopher Chiu,Lixia Pei,Carla de Boer,Elena Smith,William Deraedt,Tobias Kampfenkel,Jordan M. Schecter,Jessica Vermeulen,Hervé Avet-Loiseau,Pieter Sonneveld +57 more
TL;DR: D-VTd before and after autologous stem-cell transplantation improved depth of response and progression-free survival with acceptable safety and CASSIOPEIA is the first study showing the clinical benefit of daratumumab plus standard of care in transplant-eligible patients with newly diagnosed multiple myeloma.
Journal ArticleDOI
Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial
Peter M. Voorhees,Jonathan L. Kaufman,Jacob P. Laubach,Douglas W. Sborov,Brandi Reeves,Cesar Rodriguez,Ajai Chari,Rebecca Silbermann,Luciano J. Costa,Larry D. Anderson,Nitya Nathwani,Nina Shah,Yvonne A. Efebera,Sarah A. Holstein,Caitlin Costello,Andrzej Jakubowiak,Tanya M. Wildes,Robert Z. Orlowski,Kenneth H. Shain,Andrew J. Cowan,Sean Murphy,Yana Lutska,Huiling Pei,Jon Ukropec,Jessica Vermeulen,Carla de Boer,Daniela Hoehn,Thomas S. Lin,Paul G. Richardson +28 more
TL;DR: Daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns.
Journal ArticleDOI
Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy.
Ujjawal H. Gandhi,Robert F. Cornell,Arjun Lakshman,Zhubin Gahvari,Elizabeth McGehee,Megan Jagosky,Ridhi Gupta,William Varnado,Mark A. Fiala,Saurabh Chhabra,Ehsan Malek,Joshua Mansour,Barry Paul,Alyssa Barnstead,Saranya Kodali,Amarendra K. Neppalli,Michaela Liedtke,Swapna Narayana,Kelly N. Godby,Yubin Kang,Ankit Kansagra,Elvira Umyarova,Emma C. Scott,Parameswaran Hari,Ravi Vij,Saad Z. Usmani,Natalie S. Callander,Shaji Kumar,Luciano J. Costa +28 more
TL;DR: Patients with MM refractory to CD38 MoAB have poor prognosis and this study provides benchmark for new therapies to be tested in this population.
Journal ArticleDOI
Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial
Maria-Victoria Mateos,Michele Cavo,Joan Bladé,Meletios A. Dimopoulos,Kenshi Suzuki,Andrzej Jakubowiak,Stefan Knop,Chantal Doyen,Paulo Sérgio Lucio,Zsolt Nagy,Ludek Pour,Mark Cook,Sebastian Grosicki,Andre Crepaldi,Anna Marina Liberati,Philip Campbell,Tatiana Shelekhova,Sung-Soo Yoon,Genadi Iosava,Tomoaki Fujisaki,Mamta Garg,Maria Krevvata,Ying Chen,Jianping Wang,Anupa Kudva,Jon Ukropec,Susan Wroblewski,Ming Qi,Rachel Kobos,Jesús F. San-Miguel +29 more
TL;DR: The primary endpoint was progression-free survival, which has been reported previously, and remained significantly improved for the D-VMP group, and results presented are from a prespecified interim analysis for overall survival.
Journal ArticleDOI
Clinical Applications and Future Directions of Minimal Residual Disease Testing in Multiple Myeloma.
TL;DR: This mini-review will focus on currently available techniques and data on MRD testing and their potential future applications.
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International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma.
S. Vincent Rajkumar,Meletios A. Dimopoulos,Antonio Palumbo,Joan Bladé,Giampaolo Merlini,Maria-Victoria Mateos,Shaji Kumar,Jens Hillengass,Efstathios Kastritis,Paul G. Richardson,Ola Landgren,Bruno Paiva,Angela Dispenzieri,Brendan M. Weiss,Xavier Leleu,Sonja Zweegman,Sagar Lonial,Laura Rosiñol,Elena Zamagni,Sundar Jagannath,O. Sezer,Sigurdur Y. Kristinsson,Jo Caers,Saad Z. Usmani,Juan José Lahuerta,Hans Erik Johnsen,Meral Beksac,Michele Cavo,Hartmut Goldschmidt,Evangelos Terpos,Robert A. Kyle,Kenneth C. Anderson,Brian G.M. Durie,Jesús F. San Miguel +33 more
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Journal ArticleDOI
Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma.
Jesús F. San Miguel,Rudolf Schlag,Nuriet K. Khuageva,Meletios A. Dimopoulos,Ofer Shpilberg,Martin Kropff,Ivan Spicka,Maria Teresa Petrucci,Antonio Palumbo,Olga Samoilova,Anna Dmoszynska,Kudrat Abdulkadyrov,Rik Schots,Bin Jiang,Maria-Victoria Mateos,Kenneth C. Anderson,Dixie Lee Esseltine,Kevin Liu,Andrew Cakana,Helgi van de Velde,Paul G. Richardson +20 more
TL;DR: Bortezomib plus melphalan-prednisone alone in patients with newly diagnosed myeloma who were ineligible for high-dose therapy was superior to melphAlan-predisonsone alone.
Journal ArticleDOI
International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma
Shaji Kumar,Bruno Paiva,Kenneth C. Anderson,Brian G.M. Durie,Ola Landgren,Philippe Moreau,Nikhil C. Munshi,Sagar Lonial,Joan Bladé,Maria-Victoria Mateos,Meletios A. Dimopoulos,Efstathios Kastritis,Mario Boccadoro,Mario Boccadoro,Robert Z. Orlowski,Hartmut Goldschmidt,Andrew Spencer,Jian Hou,Wee Joo Chng,Saad Z. Usmani,Elena Zamagni,Kazuyuki Shimizu,Sundar Jagannath,Hans Erik Johnsen,Evangelos Terpos,Anthony Reiman,Robert A. Kyle,Pieter Sonneveld,Paul G. Richardson,Philip L. McCarthy,Heinz Ludwig,Wenming Chen,Michele Cavo,Jean Luc Harousseau,Suzanne Lentzsch,Jens Hillengass,Antonio Palumbo,Alberto Orfao,S. Vincent Rajkumar,Jesús F. San Miguel,Hervé Avet-Loiseau +40 more
TL;DR: Several aspects of disease response assessment are clarified, along with endpoints for clinical trials, and future directions for disease response assessments are highlighted, to allow uniform reporting within and outside clinical trials.
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