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Phase III randomised study of dexamethasone with or without oblimersen sodium for patients with advanced multiple myeloma
Leukemia and Lymphoma, 04/20/09
Chanan-Khan AA et al. - Study reports that the addition of oblimersen (a bcl-2 antisense oligonucleotide) to dexamethasone makes no significant difference in the clinical outcome of pts treated for relapsed/refractory myeloma.
Methods- Phase III trial to investigate whether addition of oblimersen to dexamethasone improves clinical outcomes vs. dexamethasone alone. in patients with relapsed/refractory myeloma
- 224 pts to receive either oblimersen/dexamethasone (N=110) or dexamethasone alone (N=114)
- Primary endpoint: time to tumor progression (TTP)
- No significant differences between the two groups in TTP or objective response rate
- The oblimersen/dexamethasone regimen was generally well tolerated
- Fatigue, fever and nausea were the most common AEs
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