Background High-dose therapy with melphalan can prolong survivalamong patients with multiple myeloma. We assessed whether theaddition of thalidomide, which has activity against advancedand refractory myeloma, would further improve survival.
Methods Between October 1998 and February 2004, 668 patientswith newly diagnosed multiple myeloma received two cycles ofintensive melphalan-based chemotherapy, each supported by autologoushematopoietic stem-cell transplantation. A total of 323 wererandomly assigned to receive thalidomide from the outset untildisease progression or undue adverse effects, and 345 did notreceive thalidomide. The primary end point was the five-yearevent-free survival rate. Secondary end points were completeresponse and overall survival.
Results After a median follow-up of 42 months among survivors,the thalidomide and control groups had rates of complete responseof 62 percent and 43 percent, respectively (P<0.001), andfive-year event-free survival rates of 56 percent and 44 percent(P=0.01). The five-year rate of overall survival was approximately65 percent in both groups (P=0.90). Median survival after relapsewas 1.1 years in the thalidomide group and 2.7 years in thecontrol group (P=0.001). Severe peripheral neuropathy and deep-veinthrombosis occurred more frequently in the thalidomide groupthan in the control group.
Conclusions When incorporated into high-dose therapy for myeloma,thalidomide increased the frequency of complete responses andextended event-free survival at the expense of added adverseeffects without improving overall survival. (ClinicalTrials.govnumber, NCT00083551
[ClinicalTrials.gov]
.)
Source Information
From the Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock (B.B., G.T., E.A., J.S., F.R., A.F., M.Z., K.H., M.P.-R., C.L., G.T., R.T., E.K., S.K., M.F.); and Cancer Research and Biostatistics, University of Washington, Seattle (E.R., J.C.).
Address reprint requests to Dr. Barlogie at the Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, 4301 W. Markham St., Mail Slot 816, Little Rock, AR 72205, or at barlogiebart{at}uams.edu.
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