Clinically relevant end points and new drug approvals for myeloma

K. C. Anderson, R. A. Kyle, S. V. Rajkumar, A. K. Stewart, D. Weber, P. Richardson

Research output: Contribution to journalEditorial

135 Scopus citations

Abstract

This manuscript summarizes the recommendations of the American Society of Hematology/US Food and Drug Administration Workshop on Clinical Endpoints in Multiple Myeloma, which brought together clinical investigators in multiple myeloma, the United States Food and Drug Administration, pharmaceutical companies, patient advocates and other concerned scientists and physicians to provide guidance, consensus and consistency in the definition of clinically relevant end points to expedite new drug approvals for multiple myeloma in the appropriate trial design settings. This manuscript will therefore be a most valuable resource to provide the framework for the design of appropriate clinical trial strategies for more rapid new drug approval in myeloma.

Original languageEnglish (US)
Pages (from-to)231-239
Number of pages9
JournalLeukemia
Volume22
Issue number2
DOIs
StatePublished - Feb 2008

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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