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

First thalidomide clinical trial in multiple myeloma: a decade

Frits van Rhee  1 , Madhav Dhodapkar, John D Shaughnessy Jr, Elias Anaissie, David Siegel, Antje Hoering, Jerome Zeldis, Bonnie Jenkins, Seema Singhal, Jayesh Mehta, John Crowley, Sundar Jagannath, Bart Barlogie
Affiliations
Clinical Trial

First thalidomide clinical trial in multiple myeloma: a decade

Frits van Rhee et al. Blood. .

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.

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Figures

Figure 1
Figure 1
Survival outcomes after starting thalidomide therapy. (A) Overall and event-free survival for all 169 patients. At 6 years, 18% of the original 169 enrolled were alive and 8% event-free. (B) Overall and event-free survival according to cumulative thalidomide dose consumed within the first 3 months from protocol start. Patients whose cumulative thalidomide dose exceeded 42 g within 90 days of enrollment had significantly longer OS and EFS. (C) Overall and event-free survival comparisons according to the presence of cytogenetic abnormalities detected within 3 months before protocol enrollment. Patients without cytogenetic abnormalities (CA) enjoyed superior overall and event-free survival. (D) Overall and event-free survival according to the number of independent adverse parameters present before protocol enrollment (cytogenetic abnormalities (CA), λ light chain). Overall survival and event-free survival were superior in patients lacking cytogenetic abnormalities and exhibiting κ light chain isotypes.
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