First thalidomide clinical trial in multiple myeloma: a decade later

van Rhee F, Shaughnessy Jr JD, Anaissie E, Siegel D, Hoering A, Zeldis J, Jenkins B, Singhal S, Mehta J, Crowley J, Jagannath S, Barlogie B.

Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock.

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 event-free, with a median follow-up of 9.2 years. According to multivariate analysis of pre-treatment variables, cytogenetic abnormalities (CA), 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<0.0001).>

PMID: 18502827 [PubMed - as supplied by publisher]