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, Alan Solomon, A. Wechalekar, J. ZonDer, A. Dispenzieri, M. Gertz, H. Streicher, M. Skinner, R. A. Kyle, G. Merlini

Research output: Contribution to journalReview article

149 Citations (Scopus)

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

Fingerprint

Amyloidosis
Clinical Trials
Guidelines
Light
Research
Immunoglobulin Light Chains
Drug Approval
Drug Design
Population

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Comenzo, R. L., Reece, D., Palladini, G., Seldin, D., Sanchorawala, V., Landau, H., ... 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

Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis. / Comenzo, R. L.; Reece, D.; Palladini, G.; Seldin, D.; Sanchorawala, V.; Landau, H.; Falk, R.; Wells, K.; Solomon, Alan; Wechalekar, A.; ZonDer, J.; Dispenzieri, A.; Gertz, M.; Streicher, H.; Skinner, M.; Kyle, R. A.; Merlini, G.

In: Leukemia, Vol. 26, No. 11, 01.11.2012, p. 2317-2325.

Research output: Contribution to journalReview article

Comenzo, RL, 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, RA & Merlini, G 2012, 'Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis', Leukemia, vol. 26, no. 11, pp. 2317-2325. https://doi.org/10.1038/leu.2012.100
Comenzo RL, Reece D, Palladini G, Seldin D, Sanchorawala V, Landau H et al. Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis. Leukemia. 2012 Nov 1;26(11):2317-2325. https://doi.org/10.1038/leu.2012.100
Comenzo, R. L. ; Reece, D. ; Palladini, G. ; Seldin, D. ; Sanchorawala, V. ; Landau, H. ; Falk, R. ; Wells, K. ; Solomon, Alan ; Wechalekar, A. ; ZonDer, J. ; Dispenzieri, A. ; Gertz, M. ; Streicher, H. ; Skinner, M. ; Kyle, R. A. ; Merlini, G. / Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis. In: Leukemia. 2012 ; Vol. 26, No. 11. pp. 2317-2325.
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