Phase III randomised study of dexamethasone with or without oblimersen sodium for patients with advanced multiple myeloma

Asher Chanan-Khan, Ruben Niesvizky, Raymond J. Hohl, Todd M. Zimmerman, Neal P. Christiansen, Gary J. Schiller, Natalie Callander, John Lister, Martin Oken, Sundar Jagannath

Research output: Contribution to journalArticlepeer-review

52 Scopus citations

Abstract

Upregulation of the Bcl-2 antiapoptotic protein is reported to be associated with aggressive clinical course in multiple myeloma. Oblimersen sodium is a bcl-2 antisense oligonucleotide complementary to the first six codons of the open-reading frame of bcl-2 mRNA that can decrease transcription of Bcl-2 protein and increase myeloma cell susceptibility to cytotoxic agents. In this phase III randomised trial, we investigated in patients with relapsed/refractory myeloma whether addition of oblimersen to dexamethasone improved clinical outcomes vs. dexamethasone alone. Two hundred and twenty-four patients were randomised to receive either oblimersen/dexamethasone (N = 110) or dexamethasone alone (N = 114). The primary endpoint was time to tumor progression (TTP). Final results of this study demonstrated no significant differences between the two groups in TTP or objective response rate. The oblimersen/dexamethasone regimen was generally well tolerated with fatigue, fever and nausea, the most common adverse events reported.

Original languageEnglish (US)
Pages (from-to)559-565
Number of pages7
JournalLeukemia and Lymphoma
Volume50
Issue number4
DOIs
StatePublished - 2009

Keywords

  • Bcl-2 antisense
  • G3139
  • Genasense®
  • Multiple myeloma
  • Oblimersen

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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