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 | Zendy

Hans Erik Johnsen | Zendy; Lene Meldgaard Knudsen | Zendy; Anne K. Mylin | Zendy; Peter Gimsing | Zendy; Henrik Gregersen | Zendy; Niels Abildgaard | Zendy; Niels Frost Andersen | Zendy; Torben Plesner | Zendy; Annette Juul Vangsted | Zendy; Torben MouritsAndersen | Zendy

Open Access

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

Author(s) -

Hans Erik Johnsen,

Lene Meldgaard Knudsen,

Anne K. Mylin,

Peter Gimsing,

Henrik Gregersen,

Niels Abildgaard,

Niels Frost Andersen,

Torben Plesner,

Annette Juul Vangsted,

Torben MouritsAndersen

Publication year - 2009

Publication title -

hematology reports

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.239

H-Index - 12

ISSN - 2038-8330

DOI - 10.4081/hr.2009.e11

Subject(s) - medicine , fludarabine , interim analysis , dexamethasone , placebo , cyclophosphamide , multiple myeloma , interim , oncology , surgery , chemotherapy , randomized controlled trial , pathology , alternative medicine , archaeology , history

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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