Clinically relevant end points and new drug approvals for myeloma

K. C. Anderson, R. A. Kyle, S Vincent Rajkumar, Alexander Keith Stewart, D. Weber, P. Richardson

Research output: Contribution to journalArticle

128 Citations (Scopus)

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

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Drug Approval
Multiple Myeloma
United States Food and Drug Administration
Research Personnel
Clinical Trials
Physicians
Education
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Hematology
  • Cancer Research

Cite this

Clinically relevant end points and new drug approvals for myeloma. / Anderson, K. C.; Kyle, R. A.; Rajkumar, S Vincent; Stewart, Alexander Keith; Weber, D.; Richardson, P.

In: Leukemia, Vol. 22, No. 2, 02.2008, p. 231-239.

Research output: Contribution to journalArticle

Anderson, K. C. ; Kyle, R. A. ; Rajkumar, S Vincent ; Stewart, Alexander Keith ; Weber, D. ; Richardson, P. / Clinically relevant end points and new drug approvals for myeloma. In: Leukemia. 2008 ; Vol. 22, No. 2. pp. 231-239.
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