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

Author:

Rajkumar S. Vincent1,Harousseau Jean-Luc2,Durie Brian3,Anderson Kenneth C.4,Dimopoulos Meletios5,Kyle Robert1,Blade Joan6,Richardson Paul4,Orlowski Robert7,Siegel David8,Jagannath Sundar9,Facon Thierry10,Avet-Loiseau Hervé2,Lonial Sagar11,Palumbo Antonio12,Zonder Jeffrey13,Ludwig Heinz14,Vesole David8,Sezer Orhan15,Munshi Nikhil C.416,San Miguel Jesus17,

Affiliation:

1. Mayo Clinic, Rochester, MN;

2. Universitaire de Nantes, Nantes, France;

3. Cedars-Sinai Medical Center, Los Angeles, CA;

4. Dana-Farber Cancer Institute, Boston, MA;

5. University of Athens, Athens, Greece;

6. Hospital Clinic in Barcelona, Barcelona, Spain;

7. M. D. Anderson Cancer Center, Houston, TX;

8. John Theurer Cancer Center, Hackensack, NJ;

9. Mt Sinai Medical Center, New York, NY;

10. Universitaire de Lille, Lille, France;

11. Winship Cancer Institute/Emory Clinic, Atlanta, GA;

12. University of Torino, Torino, Italy;

13. Karmanos Cancer Center, Detroit, MI;

14. Wilhelminen Hospital, Vienna, Austria;

15. University Medical Center, Hamburg, Germany;

16. Boston Veterans Administration Healthcare System, West Roxbury, MA; and

17. Hospital Universitario, Instituto de Biología Molecular y Celular del Cáncer, Centro de Investigación del Cáncer, Salamanca, Spain

Abstract

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.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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