TY - JOUR
T1 - 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
AU - Johnsen, Hans Erik
AU - Knudsen, Lene Meldgaard
AU - Mylin, Anne Kærsgaard
AU - Gimsing, Peter
AU - Gregersen, Henrik
AU - Abildgaard, Niels
AU - Andersen, Niels Frost
AU - Plesner, Torben
AU - Vangsted, Annette Juul
AU - Mouritz-Andersen, Torben
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
M3 - Journal article
SN - 1970-6790
VL - 1
SP - 62
EP - 64
JO - Hematology Reports
JF - Hematology Reports
ER -