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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

Hematology Reports

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Title Statement 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
Added Entry - Uncontrolled Name Hans E. Johnsen; Department of Haematology, Aalborg Hospital, Aarhus University Hospital
Lene M. Knudsen; Department of Haeatology, Odense University Hospital
Anne K. Mylin; Rigshospitalet
Peter Gimsing; Department of Haematology, Rigshospitalet
Henrik Gregersen; Department of Haematology, Aalborg Hospital, Aarhus University Hospital
Niels Abildgaard; Department of Haematology, Odense University Hospital
Niels Frost Andersen; Department of Haematology, Aarhus Hospital, University of Aarhus
Torben Plesner; Department of Haematology, Vejle Hospital
Annette Vangsted; Department of Haematology, Herlev Hospital, University of Copenhagen
Torben Mourits-Andersen; Department of Haematology, Esbjerg Hospital
The Nordic Myeloma Study Group; Schering Nordic AB; Amgen AB; Nordic Cancer Union; the Danish Cancer Society; the Danish Research Agency; the EU 6th FP
Uncontrolled Index Term Medicine; Hematology; Multiple Myeloma
Multiple Myeloma; Clinical trial; Fludarabine
Summary, etc. 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.
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Data Source Entry Hematology Reports; Vol 1, No 2 (2009); e11
Language Note en
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