Literature DB >> 21292775

Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1.

S Vincent Rajkumar1, Jean-Luc Harousseau, Brian Durie, Kenneth C Anderson, Meletios Dimopoulos, Robert Kyle, Joan Blade, Paul Richardson, Robert Orlowski, David Siegel, Sundar Jagannath, Thierry Facon, Hervé Avet-Loiseau, Sagar Lonial, Antonio Palumbo, Jeffrey Zonder, Heinz Ludwig, David Vesole, Orhan Sezer, Nikhil C Munshi, Jesus San Miguel.   

Abstract

It is essential that there be consistency in the conduct, analysis, and reporting of clinical trial results in myeloma. The goal of the International Myeloma Workshop Consensus Panel 1 was to develop a set of guidelines for the uniform reporting of clinical trial results in myeloma. This paper provides a summary of the current response criteria in myeloma, detailed definitions for patient populations, lines of therapy, and specific endpoints. We propose that future clinical trials in myeloma follow the guidelines for reporting results proposed in this manuscript.

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Year:  2011        PMID： 21292775      PMCID： PMC3710442          DOI： 10.1182/blood-2010-10-299487

Source DB:  PubMed          Journal:  Blood        ISSN： 0006-4971            Impact factor:   22.113


  15 in total

1.  Assessing response rates in clinical trials of treatment for relapsed or refractory multiple myeloma: a study of bortezomib and thalidomide.

Authors:  H M Prince; B Schenkel; L Mileshkin
Journal:  Leukemia       Date:  2007-02-15       Impact factor: 11.528

2.  Eliminating the complete response penalty from myeloma response assessment.

Authors:  Sagar Lonial; Morie A Gertz
Journal:  Blood       Date:  2008-03-15       Impact factor: 22.113

3.  Eliminating the complete response penalty from myeloma response criteria.

Authors:  S Vincent Rajkumar; Brian G M Durie
Journal:  Blood       Date:  2008-06-15       Impact factor: 22.113

4.  The role of anatomic and functional staging in myeloma: description of Durie/Salmon plus staging system.

Authors:  Brian G M Durie
Journal:  Eur J Cancer       Date:  2006-06-13       Impact factor: 9.162

5.  Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study.

Authors:  María-Victoria Mateos; José-M Hernández; Miguel-T Hernández; Norma-C Gutiérrez; Luis Palomera; Marta Fuertes; Joaquín Díaz-Mediavilla; Juan-J Lahuerta; Javier de la Rubia; María-José Terol; Ana Sureda; Joan Bargay; Paz Ribas; Felipe de Arriba; Adrian Alegre; Albert Oriol; Dolores Carrera; José García-Laraña; Ramón García-Sanz; Joan Bladé; Felipe Prósper; Gemma Mateo; Dixie-Lee Esseltine; Helgi van de Velde; Jesús-F San Miguel
Journal:  Blood       Date:  2006-06-13       Impact factor: 22.113

6.  International uniform response criteria for multiple myeloma.

Authors:  B G M Durie; J-L Harousseau; J S Miguel; J Bladé; B Barlogie; K Anderson; M Gertz; M Dimopoulos; J Westin; P Sonneveld; H Ludwig; G Gahrton; M Beksac; J Crowley; A Belch; M Boccadaro; M Cavo; I Turesson; D Joshua; D Vesole; R Kyle; R Alexanian; G Tricot; M Attal; G Merlini; R Powles; P Richardson; K Shimizu; P Tosi; G Morgan; S V Rajkumar
Journal:  Leukemia       Date:  2006-07-20       Impact factor: 11.528

Review 7.  Multiple myeloma.

Authors:  Robert A Kyle; S Vincent Rajkumar
Journal:  Blood       Date:  2008-03-15       Impact factor: 22.113

8.  Clinically relevant end points and new drug approvals for myeloma.

Authors:  K C Anderson; R A Kyle; S V Rajkumar; A K Stewart; D Weber; P Richardson
Journal:  Leukemia       Date:  2007-11-01       Impact factor: 11.528

9.  A phase 2 study of bortezomib in relapsed, refractory myeloma.

Authors:  Paul G Richardson; Bart Barlogie; James Berenson; Seema Singhal; Sundar Jagannath; David Irwin; S Vincent Rajkumar; Gordan Srkalovic; Melissa Alsina; Raymond Alexanian; David Siegel; Robert Z Orlowski; David Kuter; Steven A Limentani; Stephanie Lee; Teru Hideshima; Dixie-Lee Esseltine; Michael Kauffman; Julian Adams; David P Schenkein; Kenneth C Anderson
Journal:  N Engl J Med       Date:  2003-06-26       Impact factor: 91.245

10.  Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma.

Authors:  Jesús F San Miguel; Rudolf Schlag; Nuriet K Khuageva; Meletios A Dimopoulos; Ofer Shpilberg; Martin Kropff; Ivan Spicka; Maria T Petrucci; Antonio Palumbo; Olga S Samoilova; Anna Dmoszynska; Kudrat M Abdulkadyrov; Rik Schots; Bin Jiang; Maria-Victoria Mateos; Kenneth C Anderson; Dixie L Esseltine; Kevin Liu; Andrew Cakana; Helgi van de Velde; Paul G Richardson
Journal:  N Engl J Med       Date:  2008-08-28       Impact factor: 91.245
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  299 in total

1.  Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase 1/2 open-label, dose escalation study.

Authors:  Suzanne Lentzsch; Amy O'Sullivan; Ryan C Kennedy; Mohammad Abbas; Lijun Dai; Silvana Lalo Pregja; Steve Burt; Michael Boyiadzis; G David Roodman; Markus Y Mapara; Mounzer Agha; John Waas; Yongli Shuai; Daniel Normolle; Jeffrey A Zonder
Journal:  Blood       Date:  2012-03-26       Impact factor: 22.113

2.  High-dose infusional gemcitabine combined with busulfan and melphalan with autologous stem-cell transplantation in patients with refractory lymphoid malignancies.

Authors:  Yago Nieto; Peter Thall; Ben Valdez; Borje Andersson; Uday Popat; Paolo Anderlini; Elizabeth J Shpall; Roland Bassett; Amin Alousi; Chitra Hosing; Partow Kebriaei; Muzaffar Qazilbash; Erin Frazier; Alison Gulbis; Christina Chancoco; Qaiser Bashir; Stefan Ciurea; Issa Khouri; Simrit Parmar; Nina Shah; Laura Worth; Gabriela Rondon; Richard Champlin; Roy B Jones
Journal:  Biol Blood Marrow Transplant       Date:  2012-05-27       Impact factor: 5.742

3.  Clarification of the definition of complete response in multiple myeloma.

Authors:  B G M Durie; J F S Miguel; J Blade; S V Rajkumar
Journal:  Leukemia       Date:  2015-10-21       Impact factor: 11.528

4.  High melphalan exposure is associated with improved overall survival in myeloma patients receiving high dose melphalan and autologous transplantation.

Authors:  Christa E Nath; Judith Trotman; Campbell Tiley; Peter Presgrave; Douglas Joshua; Ian Kerridge; Yiu Lam Kwan; Howard Gurney; Andrew J McLachlan; John W Earl; Ian Nivison-Smith; Lihua Zeng; Peter J Shaw
Journal:  Br J Clin Pharmacol       Date:  2016-04-27       Impact factor: 4.335

5.  Whole-body MRI and PET/CT in multiple myeloma patients during staging and after treatment: personal experience in a longitudinal study.

Authors:  Giuseppe Lucio Cascini; Carmela Falcone; Domenico Console; Antonino Restuccia; Marco Rossi; Antonello Parlati; Oscar Tamburrini
Journal:  Radiol Med       Date:  2013-06-26       Impact factor: 3.469

6.  Carfilzomib, lenalidomide, and dexamethasone plus transplant in newly diagnosed multiple myeloma.

Authors:  Jagoda K Jasielec; Tadeusz Kubicki; Noopur Raje; Ravi Vij; Donna Reece; Jesus Berdeja; Benjamin A Derman; Cara A Rosenbaum; Paul Richardson; Sandeep Gurbuxani; Sarah Major; Brittany Wolfe; Andrew T Stefka; Leonor Stephens; Kathryn M Tinari; Tyler Hycner; Alexandra E Rojek; Dominik Dytfeld; Kent A Griffith; Todd M Zimmerman; Andrzej J Jakubowiak
Journal:  Blood       Date:  2020-11-26       Impact factor: 22.113

7.  Outcome of autologous hematopoietic stem cell transplantation in refractory multiple myeloma.

Authors:  Lauren W Veltri; Denái R Milton; Ruby Delgado; Nina Shah; Krina Patel; Yago Nieto; Partow Kebriaei; Uday R Popat; Simrit Parmar; Betul Oran; Stefan Ciurea; Chitra Hosing; Hans C Lee; Elisabet Manasanch; Robert Z Orlowski; Elizabeth J Shpall; Richard E Champlin; Muzaffar H Qazilbash; Qaiser Bashir
Journal:  Cancer       Date:  2017-05-17       Impact factor: 6.860

8.  Current approaches to the initial treatment of symptomatic multiple myeloma.

Authors:  Jagoda K Jasielec; Andrzej J Jakubowiak
Journal:  Int J Hematol Oncol       Date:  2013-02

9.  Filgrastim-alone versus pegylated filgrastim-alone for autologous peripheral blood stem cells mobilization in newly diagnosed multiple myeloma patients.

Authors:  Barbara Skopec; Matevz Skerget; Darja Zontar; Vesna Zadnik; Samo Zver
Journal:  Wien Klin Wochenschr       Date:  2017-04-24       Impact factor: 1.704

10.  Bendamustine, bortezomib and prednisone for the treatment of patients with newly diagnosed multiple myeloma: results of a prospective phase 2 Spanish/PETHEMA trial.

Authors:  María-Victoria Mateos; Albert Oriol; Laura Rosiñol; Felipe de Arriba; Noemí Puig; Jesús Martín; Joaquín Martínez-López; María Asunción Echeveste; Josep Sarrá; Enrique Ocio; Gemma Ramírez; Rafael Martínez; Luis Palomera; Angel Payer; Rebeca Iglesias; Javier de la Rubia; Adrian Alegre; Ana Isabel Chinea; Joan Bladé; Juan José Lahuerta; Jesús-F San Miguel
Journal:  Haematologica       Date:  2015-04-24       Impact factor: 9.941
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