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Previous Volume 359:906-917 August 28, 2008 Number 9 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set CME Exam Supplementary Material Purchase this article Editorial by Durie, B. G.M. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background The standard treatment for patients with multiple myeloma who are not candidates for high-dose therapy is melphalan and prednisone. This phase 3 study compared the use of melphalan and prednisone with or without bortezomib in previously untreated patients with multiple myeloma who were ineligible for high-dose therapy.

Methods We randomly assigned 682 patients to receive nine 6-week cycles of melphalan (at a dose of 9 mg per square meter of body-surface area) and prednisone (at a dose of 60 mg per square meter) on days 1 to 4, either alone or with bortezomib (at a dose of 1.3 mg per square meter) on days 1, 4, 8, 11, 22, 25, 29, and 32 during cycles 1 to 4 and on days 1, 8, 22, and 29 during cycles 5 to 9. The primary end point was the time to disease progression.

Results The time to progression among patients receiving bortezomib plus melphalan–prednisone (bortezomib group) was 24.0 months, as compared with 16.6 months among those receiving melphalan–prednisone alone (control group) (hazard ratio for the bortezomib group, 0.48; P<0.001). The proportions of patients with a partial response or better were 71% in the bortezomib group and 35% in the control group; complete-response rates were 30% and 4%, respectively (P<0.001). The median duration of the response was 19.9 months in the bortezomib group and 13.1 months in the control group. The hazard ratio for overall survival was 0.61 for the bortezomib group (P=0.008). Adverse events were consistent with established profiles of toxic events associated with bortezomib and melphalan–prednisone. Grade 3 events occurred in a higher proportion of patients in the bortezomib group than in the control group (53% vs. 44%, P=0.02), but there were no significant differences in grade 4 events (28% and 27%, respectively) or treatment-related deaths (1% and 2%).

Conclusions Bortezomib plus melphalan–prednisone was superior to melphalan–prednisone alone in patients with newly diagnosed myeloma who were ineligible for high-dose therapy. (ClinicalTrials.gov number, NCT00111319 [ClinicalTrials.gov] .)

Source Information

The authors' affiliations are listed in the Appendix.

Address reprint requests to Dr. San Miguel at Hospital Universitario de Salamanca, Paseo San Vicente 58-182, 37007 Salamanca, Spain, or at sanmigiz{at}usal.es.

Full Text of this Article

This article has been cited by other articles:

• (2008). All you need to read in the other general journals. BMJ 337: a1510-a1510 [Full Text]  
• Durie, B. G.M. (2008). Treatment of Myeloma -- Are We Making Progress?. NEJM 359: 964-966 [Full Text]  
• (2008). Bortezomib plus Melphalan and Prednisone for Multiple Myeloma. JWatch Oncology and Hematology 2008: 1-1 [Full Text]