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.

• Authors: 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
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 50 Issue 4 Pg. 559-65 (Apr 2009) ISSN: 1029-2403 [Electronic] United States
• PMID: 19373653 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents, Hormonal
• Oligonucleotides, Antisense
• Thionucleotides
• Dexamethasone
• oblimersen

Topics

• Antineoplastic Agents, Hormonal (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Dexamethasone (administration & dosage, adverse effects, therapeutic use)
• Drug Administration Schedule
• Fatigue (chemically induced)
• Female
• Fever (chemically induced)
• Humans
• Male
• Middle Aged
• Multiple Myeloma (drug therapy, pathology)
• Nausea (chemically induced)
• Oligonucleotides, Antisense (administration & dosage)
• Thionucleotides (administration & dosage)
• Treatment Outcome