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 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, International Myeloma Workshop Consensus Panel 1, Noopur Raje, Franco Dammacco, Faith Davies, Shaji Kumar, Andrew R Belch, Mohamad Hussein, Morie A Gertz, Ashraf Badros, John Crowley, Larry Kwak, Irene M Ghrobrial, Gosta Gahrton, James R Berenson, Jayesh Mehta, Angela Dispenzieri, R L Powles, Nicolaus Kroger, Michele Cavo, Ruben Niesvizky, Pieter Sonneveld, Jan Westin, James Child, William S Dalton, Asher Chanan-Khan, Angelina Rodriguez, Ramon Garcia Sanz, William Bensinger, Michel Attal, Seema Singhal, Michael Wang, Vinod Raina, S Vincent Rajkumar, 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, International Myeloma Workshop Consensus Panel 1, Noopur Raje, Franco Dammacco, Faith Davies, Shaji Kumar, Andrew R Belch, Mohamad Hussein, Morie A Gertz, Ashraf Badros, John Crowley, Larry Kwak, Irene M Ghrobrial, Gosta Gahrton, James R Berenson, Jayesh Mehta, Angela Dispenzieri, R L Powles, Nicolaus Kroger, Michele Cavo, Ruben Niesvizky, Pieter Sonneveld, Jan Westin, James Child, William S Dalton, Asher Chanan-Khan, Angelina Rodriguez, Ramon Garcia Sanz, William Bensinger, Michel Attal, Seema Singhal, Michael Wang, Vinod Raina
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.
Source: PubMed