Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis

R. L. Comenzo, D. Reece, G. Palladini, D. Seldin, V. Sanchorawala, H. Landau, R. Falk, K. Wells, A. Solomon, A. Wechalekar, J. ZonDer, A. Dispenzieri, M. Gertz, H. Streicher, M. Skinner, R. A. Kyle, G. Merlini

Research output: Contribution to journalReview article

190 Scopus citations

Abstract

This manuscript summarizes the recommendations that emerged from the first Roundtable on Clinical Research in Immunoglobulin Light-chain Amyloidosis (AL), a meeting sponsored by the Amyloidosis Foundation (Clarkston, MI, USA) to develop a consensus of experts on a moDern framework for clinical trial design and drug development in AL. Recent diagnostic and technical advances in AL, and updated consensus guidelines for assessing hematologic and organ responses, enable us to define study populations, appropriate end points, and other criteria for all phases of clinical research. This manuscript provides a framework for the design and conduct of systematic collaborative clinical research in AL to encourage more rapid testing of therapies and to expedite new drug development and approval.

Original languageEnglish (US)
Pages (from-to)2317-2325
Number of pages9
JournalLeukemia
Volume26
Issue number11
DOIs
StatePublished - Nov 1 2012

Keywords

  • Amyloidosis
  • Clinical research
  • Clinical trials
  • Free light chains

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Comenzo, R. L., Reece, D., Palladini, G., Seldin, D., Sanchorawala, V., Landau, H., Falk, R., Wells, K., Solomon, A., Wechalekar, A., ZonDer, J., Dispenzieri, A., Gertz, M., Streicher, H., Skinner, M., Kyle, R. A., & Merlini, G. (2012). Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis. Leukemia, 26(11), 2317-2325. https://doi.org/10.1038/leu.2012.100