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 Blood, 15 August 2008, Vol. 112, No. 4, pp. 1035-1038.
Prepublished online as a Blood First Edition Paper on May 23, 2008; DOI 10.1182/blood-2008-02-140954.

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CLINICAL TRIALS AND OBSERVATIONS

Brief Report

First thalidomide clinical trial in multiple myeloma: a decade

Frits van Rhee1, Madhav Dhodapkar2, John D. Shaughnessy, Jr1, Elias Anaissie1, David Siegel3, Antje Hoering4, Jerome Zeldis5, Bonnie Jenkins1, Seema Singhal6, Jayesh Mehta6, John Crowley4, Sundar Jagannath7, and Bart Barlogie1

1 Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock; 2 Yale University, New Haven, CT; 3 Hackensack University, Hackensack, NJ; 4 Cancer Research and Biostatistics, Seattle, WA; 5 Celgene, Summit, NJ; 6 Northwestern University, Chicago, IL; and 7 St Vincent Hospital, New York, NY

The clinical outcomes of 169 patients enrolled in the first clinical trial of thalidomide for advanced or refractory myeloma are updated. Seventeen patients remain alive and 10 are event-free, with a median follow-up of 9.2 years. According to multivariate analysis of pretreatment variables, cytogenetic abnormalities, present in 47% of patients within 3 months of enrollment, and {lambda} light chain isotype both affected overall survival and event-free survival adversely. Forty percent of the 58 patients lacking these 2 unfavorable features, one-half of whom had no disease recurrence, survived at least 6 years, in contrast to fewer than 5% among those with 1 or 2 risk features (P < .001). Patients who had received cumulative thalidomide doses in excess of 42 g in the first 3 months enjoyed superior overall and event-free survival. The poor outcome associated with {lambda}-type myeloma may relate to its overrepresentation in molecularly defined high-risk disease gleaned from studies in newly diagnosed myeloma.


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