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Blood, 15 July 2001, Vol. 98, No. 2, pp. 492-494

BRIEF REPORT

Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients

Bart Barlogie, Raman Desikan, Paul Eddlemon, Trey Spencer, Jerome Zeldis, Nikhil Munshi, Ashrof Badros, Maurizio Zangari, Elias Anaissie, Joshua Epstein, John Shaughnessy, Dan Ayers, Dan Spoon, and Guido Tricot

From the Myeloma and Transplantation Research Center, University of Arkansas for Medical Sciences, Little Rock, AR; and Celgene Co, Warren, NJ.

This report of a phase 2 trial of thalidomide (THAL) (200 mg/d; 200 mg increment every 2 weeks to 800 mg) for 169 patients with advanced myeloma (MM) (abnormal cytogenetics (CG), 67%; prior autotransplant, 76%) extends earlier results in 84 patients. A 25% myeloma protein reduction was obtained in 37% of patients (50% reduction in 30% of patients; near-complete or complete remission in 14%) and was more frequent with low plasma cell labeling index (PCLI) (below 0.5%) and normal CG. Two-year event-free and overall survival rates were 20% ± 6% and 48% ± 6%, respectively, and these were superior with normal CG, PCLI of less than 0.5%, and beta 2-microglobulin of 3 mg/L. Response rates were higher and survival was longer especially in high-risk patients given more than 42 g THAL in 3 months (median cumulative dose) (landmark analysis); this supports a THAL dose-response effect in advanced MM.

© 2001 by The American Society of Hematology.
 

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