Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1
S. Vincent Rajkumar,Jean Luc Harousseau,Brian G.M. Durie,Kenneth C. Anderson,Meletios A. Dimopoulos,Robert A. Kyle,Joan Bladé,Paul G. Richardson,Robert Z. Orlowski,David S. Siegel,Sundar Jagannath,Thierry Facon,Hervé Avet-Loiseau,Sagar Lonial,Antonio Palumbo,Jeffrey A. Zonder,Heinz Ludwig,David H. Vesole,O. Sezer,Nikhil C. Munshi,Nikhil C. Munshi,Jesús F. San Miguel +21 more
TLDR
It is proposed that future clinical trials in myeloma follow the guidelines for reporting results proposed in this manuscript, and detailed definitions for patient populations, lines of therapy, and specific endpoints are provided.About:
This article is published in Blood.The article was published on 2011-05-05 and is currently open access. It has received 854 citations till now. The article focuses on the topics: Clinical trial.read more
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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
TL;DR: The disease definition of multiple myeloma is updated to include validated biomarkers in addition to existing requirements of attributable CRAB features (hypercalcaemia, renal failure, anaemia, and bone lesions), and specific metrics that new biomarkers should meet for inclusion in the disease definition are provided.
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.
Journal ArticleDOI
Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma
Antonio Palumbo,Asher Chanan-Khan,Katja Weisel,Ajay K. Nooka,Tamás Masszi,Meral Beksac,Ivan Spicka,Vania Hungria,Markus Munder,Maria-Victoria Mateos,Tomer M Mark,Ming Qi,Jordan M. Schecter,Himal Amin,Xiang Qin,William Deraedt,Tahamtan Ahmadi,Andrew Spencer,Pieter Sonneveld +18 more
TL;DR: Among patients with relapsed or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexamethasone resulted in significantly longer progression-free survival than borteonib and DexamethAsone alone and was associated with infusion-related reactions and higher rates of thrombocytopenia and neutropenia.
Journal ArticleDOI
Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma
Meletios A. Dimopoulos,Albert Oriol,Hareth Nahi,Jesús F. San-Miguel,Nizar J. Bahlis,Saad Z. Usmani,Neil Rabin,Robert Z. Orlowski,Mieczysław Komarnicki,Kenshi Suzuki,Torben Plesner,Sung-Soo Yoon,Dina Ben Yehuda,Paul G. Richardson,Hartmut Goldschmidt,Hartmut Goldschmidt,Donna E. Reece,Steen Lisby,Nushmia Z. Khokhar,Lisa O'Rourke,Christopher Chiu,Xiang Qin,Mary E. Guckert,Tahamtan Ahmadi,Philippe Moreau +24 more
TL;DR: The addition of daratumumab to lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma.
Journal ArticleDOI
Targeting CD38 with daratumumab monotherapy in multiple myeloma
Henk M. Lokhorst,Torben Plesner,Jacob P. Laubach,Hareth Nahi,Peter Gimsing,Markus Hansson,Monique C. Minnema,Ulrik Lassen,Ulrik Lassen,Jakub Krejcik,Antonio Palumbo,Niels W.C.J. van de Donk,Tahamtan Ahmadi,Imran Khan,Clarissa M. Uhlar,Jianping Wang,A. Kate Sasser,Nedjad Losic,Steen Lisby,Linda Basse,Nikolai Constantin Brun,Paul G. Richardson +21 more
TL;DR: Daratumumab monotherapy had a favorable safety profile and encouraging efficacy in patients with heavily pretreated and refractory myeloma, and no maximum tolerated dose was identified in part 1.
References
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Journal ArticleDOI
A phase 2 study of bortezomib in relapsed, refractory myeloma.
Paul G. Richardson,Bart Barlogie,James R. Berenson,Seema Singhal,Sundar Jagannath,D. Irwin,S. Vincent Rajkumar,Gordan Srkalovic,Melissa Alsina,Raymond Alexanian,David S. Siegel,Robert Z. Orlowski,David J. Kuter,Steven Limentani,Stephanie J. Lee,Teru Hideshima,Dixie Lee Esseltine,Michael Kauffman,Julian Adams,David P. Schenkein,Kenneth C. Anderson +20 more
TL;DR: Bortezomib, a member of a new class of anticancer drugs, is active in patients with relapsed multiple myeloma that is refractory to conventional chemotherapy.
Journal ArticleDOI
International uniform response criteria for multiple myeloma
Brian G.M. Durie,J L Harousseau,Jesús F. San Miguel,J. Bladé,Bart Barlogie,Kenneth C. Anderson,Morie A. Gertz,Meletios A. Dimopoulos,Johan Westin,Pieter Sonneveld,Heinz Ludwig,G. Gahrton,Meral Beksac,John Crowley,Andrew Belch,M. Boccadaro,Ingemar Turesson,Douglas E. Joshua,David H. Vesole,Robert A. Kyle,Raymond Alexanian,Guido Tricot,M. Attal,Giampaolo Merlini,R. L. Powles,Paul G. Richardson,K. Shimizu,Patrizia Tosi,Gareth J. Morgan,S V Rajkumar +29 more
TL;DR: The European Group for Blood and Bone Marrow Transplant/International Bone Marrows Transplant Registry criteria have been expanded, clarified and updated to provide a new comprehensive evaluation system to adequately assess clinical outcomes in myeloma.
Journal ArticleDOI
Bortezomib or high-dose dexamethasone for relapsed multiple myeloma
Paul G. Richardson,Pieter Sonneveld,Michael W. Schuster,D. Irwin,Edward A. Stadtmauer,Thierry Facon,Jean-Luc Harousseau,Dina Ben-Yehuda,Sagar Lonial,Hartmut Goldschmidt,Donna E. Reece,Jesús F. San-Miguel,Joan Bladé,Mario Boccadoro,Jamie Cavenagh,William S. Dalton,Anthony Boral,Dixie Lee Esseltine,Jane B. Porter,David P. Schenkein,Kenneth C. Anderson +20 more
TL;DR: Bortezomib is superior to high-dose dexamethasone for the treatment of patients with multiple myeloma who have had a relapse after one to three previous therapies.
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
Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant.
Joan Bladé,Diana Samson,Donna E. Reece,Jane F. Apperley,Bo Björkstrand,Gösta Gahrton,Morie A. Gertz,Sergio Giralt,SUNDARr Jagannath,David H. Vesole +9 more
TL;DR: New criteria for response and progression have been developed as a result of discussions between representatives of the Myeloma Subcommittee of the Chronic Leukaemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT) and representatives ofThe Myelomas Working Committee of the Autologousblood and marrow transplant Registry (ABMTR) and the International Bone Marrowtransplant Registry (IBMTR).
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International uniform response criteria for multiple myeloma
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