title: First thalidomide clinical trial in multiple myeloma: a decade.
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.
authors.affiliation: Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.
authors.forename: Frits
authors.initials: F
authors.lastname: van Rhee
authors.forename: Madhav
authors.initials: M
authors.lastname: Dhodapkar
authors.forename: John D
authors.initials: JD
authors.lastname: Shaughnessy
authors.forename: Elias
authors.initials: E
authors.lastname: Anaissie
authors.forename: David
authors.initials: D
authors.lastname: Siegel
authors.forename: Antje
authors.initials: A
authors.lastname: Hoering
authors.forename: Jerome
authors.initials: J
authors.lastname: Zeldis
authors.forename: Bonnie
authors.initials: B
authors.lastname: Jenkins
authors.forename: Seema
authors.initials: S
authors.lastname: Singhal
authors.forename: Jayesh
authors.initials: J
authors.lastname: Mehta
authors.forename: John
authors.initials: J
authors.lastname: Crowley
authors.forename: Sundar
authors.initials: S
authors.lastname: Jagannath
authors.forename: Bart
authors.initials: B
authors.lastname: Barlogie
mesh_terms: D002869:Chromosome Aberrations; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D007146:Immunoglobulin lambda-Chains; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011379:Prognosis; D016019:Survival Analysis; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage* / Q000633:toxicity; D016896:Treatment Outcome
chemical_list: D007146:Immunoglobulin lambda-Chains; D013792:Thalidomide