Open AccessArticle
Up-Front Fludarabine Impairs Stem Cell Harvest in Multiple Myeloma: Report from an Interim Analysis of the NMSG 13/03 Randomized Placebo Controlled Phase II Trial
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Hans E. Johnsen, Lene M. Knudsen, Anne K. Mylin, Peter Gimsing, Henrik Gregersen, Niels Abildgaard, Niels Frost Andersen, Torben Plesner, Annette Vangsted and Torben Mourits-Andersen
Hematol. Rev. 2009, 1(2), e11; https://doi.org/10.4081/hr.2009.e11 (registering DOI) - 26 Aug 2009
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Abstract
The impact of chemotherapy resistant B cells in multiple myeloma (MM) needs to be evaluated by in vivo targeted therapy. Here we report the conclusions from a phase II randomized, placebo controlled trial adding fludarabine to the induction with cyclophosphamide-dexamethasone. Based on an
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The impact of chemotherapy resistant B cells in multiple myeloma (MM) needs to be evaluated by in vivo targeted therapy. Here we report the conclusions from a phase II randomized, placebo controlled trial adding fludarabine to the induction with cyclophosphamide-dexamethasone. Based on an interim toxicity and safety analysis, the trial was stopped following inclusion of 34 of a planned 80 patients due to a reduced number of patients (4/17) actually harvested in the experimental arm compared to the control arm (11/17;
p < 0.05). In conclusion, the scheduled fludarabine dosage in 2 cycles combined with alkylating therapy impairs stem cell mobilization and standard therapy in young MM patients and should not be administrated up-front.
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