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

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.

Keywords:

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

Notes

There is an accompanying commentary that discusses this paper. Please refer to the issue Table of Contents. Presented as an abstract and poster at the 46th Annual Meeting, American Society of Hematology; 4–7 December 2004; San Diego, California, USA.