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June 5, 2004
Results of a phase III clinical trial show that bortezomib (Velcade) improves patient survival and slows the progression of multiple myeloma that has come back after initial treatment (relapsed). Bortezomib also appears to cause fewer side effects in patients than a current standard treatment, dexamethasone.
In this study, doctors compared bortezomib to dexamethasone in 669 people with relapsed multiple myeloma. At the interim analysis, bortezomib delayed cancer progression by 5.7 months, compared with 3.6 months for dexamethasone. Survival also appeared to be better in the patients taking bortezomib, with fewer deaths in this group. The results were so significant that the study investigators stopped the trial early so all patients could receive bortezomib.
In addition, the patients who received bortezomib experienced fewer serious infections (6.7%) than the patients who received dexamethasone (10.6%).
"These results confirm the activity in patients with relapsed multiple myeloma," said lead author Paul Richardson, MD, of the Dana-Farber Cancer Institute in Boston, Mass. "Compared to dexamethasone, bortezomib had superior time to progression and less toxicity." Doctors will continue to monitor the safety and effectiveness of bortezomib in these patients.
What This Means For Patients
While these results are preliminary, they support the findings of an earlier phase II trial of bortezomib in patients with multiple myeloma, which prompted the U.S. Food and Drug Administration to approve bortezomib for the treatment of multiple myeloma in 2003. Because of this study, bortezomib may become a standard treatment option for relapsed multiple myeloma and may be studied as a therapy for patients with earlier stage multiple myeloma.