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

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

Leukemia & lymphoma 2009 Apr

filter terms:

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.

Citation

Asher A Chanan-Khan, Ruben Niesvizky, Raymond J Hohl, Todd M Zimmerman, Neal P Christiansen, Gary J Schiller, Natalie Callander, John Lister, Martin Oken, Sundar Jagannath. Phase III randomised study of dexamethasone with or without oblimersen sodium for patients with advanced multiple myeloma. Leukemia & lymphoma. 2009 Apr;50(4):559-65