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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
oleh: Hans E. Johnsen, Lene M. Knudsen, Anne K. Mylin, Peter Gimsing, Henrik Gregersen, Niels Abildgaard, Niels Frost Andersen, Torben Plesner, Annette Vangsted, Torben Mourits-Andersen
Format: | Article |
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Diterbitkan: | MDPI AG 2009-08-01 |
Deskripsi
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 lower than 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.