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Hematology Reviews
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10.4081/hr.2009.e11
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Hematology Reviews (renamed as Hematology Reports here since 2010) is published by MDPI from Volume 14 Issue 1 (2022). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with PAGEPress.
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Article

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

by
Hans E. Johnsen
1,*,
Lene M. Knudsen
2,
Anne K. Mylin
3,
Peter Gimsing
3,
Henrik Gregersen
1,
Niels Abildgaard
2,
Niels Frost Andersen
4,
Torben Plesner
5,
Annette Vangsted
6 and
Torben Mourits-Andersen
7 on behalf of the Nordic Myeloma Study Group
1
Medical Center, Aalborg Hospital Science and Innovation Center, Department of Haematology, Aarhus University Hospital, AHSIC-Sdr Skovvej 15, 9000 Aalborg, Denmark
2
Department of Haematology, Odense University Hospital, 5000 Odense, Denmark
3
Rigshospitalet, 2100 København, Denmark
4
Aarhus Hospital, University of Aarhus, 8000 Aarhus, Denmark
5
Vejle Hospital, 7100 Vejle, Denmark
6
Herlev University Hospital, 2730 Herlev, Denmark
7
Esbjerg Hospital, 6700 Esbjerg, Denmark
*
Author to whom correspondence should be addressed.
Hematol. Rev. 2009, 1(2), e11; https://doi.org/10.4081/hr.2009.e11 (registering DOI)
Submission received: 12 March 2009 / Revised: 5 July 2009 / Accepted: 21 July 2009 / Published: 26 August 2009

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 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.
Keywords: multiple myeloma; clinical trial; fludarabine multiple myeloma; clinical trial; fludarabine

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MDPI and ACS Style

Johnsen, H.E.; Knudsen, L.M.; Mylin, A.K.; Gimsing, P.; Gregersen, H.; Abildgaard, N.; Andersen, N.F.; Plesner, T.; Vangsted, A.; Mourits-Andersen, T., on behalf of the Nordic Myeloma Study Group. 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. Hematol. Rev. 2009, 1, e11. https://doi.org/10.4081/hr.2009.e11

AMA Style

Johnsen HE, Knudsen LM, Mylin AK, Gimsing P, Gregersen H, Abildgaard N, Andersen NF, Plesner T, Vangsted A, Mourits-Andersen T on behalf of the Nordic Myeloma Study Group. 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 Reviews. 2009; 1(2):e11. https://doi.org/10.4081/hr.2009.e11

Chicago/Turabian Style

Johnsen, Hans E., Lene M. Knudsen, Anne K. Mylin, Peter Gimsing, Henrik Gregersen, Niels Abildgaard, Niels Frost Andersen, Torben Plesner, Annette Vangsted, and Torben Mourits-Andersen on behalf of the Nordic Myeloma Study Group. 2009. "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 Reviews 1, no. 2: e11. https://doi.org/10.4081/hr.2009.e11

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