First thalidomide clinical trial in multiple myeloma: a decade

Blood. 2008 Aug 15;112(4):1035-8. doi: 10.1182/blood-2008-02-140954. Epub 2008 May 23.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chromosome Aberrations
  • Disease-Free Survival
  • Follow-Up Studies
  • Humans
  • Immunoglobulin lambda-Chains
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / mortality
  • Prognosis
  • Survival Analysis
  • Survival Rate
  • Thalidomide / administration & dosage*
  • Thalidomide / toxicity
  • Treatment Outcome

Substances

  • Immunoglobulin lambda-Chains
  • Thalidomide