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Multiple myeloma gammopathies

The majority of newly diagnosed myeloma patients do not fulfill the inclusion criteria in clinical phase III trials

Leukemia volume 33, pages 546–549 (2019)Cite this article

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Real-world data (RWD) are important as randomized clinical trials (RCT) have strict in- and exclusion criteria that do not allow evaluation of the effect and toxicity of new drugs or treatment modalities in patients that do not fulfill these criteria. Since 2005, clinical data on all newly diagnosed multiple myeloma (MM) patients have been registered in the Danish Multiple Myeloma Registry (DMMR) [1, 2]. The Danish National guidelines for treatment of MM, are based on the results of phase III RCT (www.myeloma.dk).

The median overall survival (OS) for patients above 65 years registered in DMMR in 2009–2014 is less as compared to the Hovon 87 trial (32.9 months (mo.) versus 48 mo.) [3, 4]. In patients eligible for high-dose melphalan with autologous stem cell transplantation (HDM-ASCT) the median OS in the DMMR was 74 mo. in 2009–2014 (Abstract 1946 EHA 2016). A review of OS for patients treated in HDM-ASCT RCT describe a 3-year OS of 80% and 75% in patients treated with and without bortezomib, respectively [5]. In the DMMR, 3-year OS was 77% in the calendar period 2009–2013 [4]. The worse OS of the elderly in the DMMR let us to compare OS for patients registered in DMMR who fulfilled the inclusion and exclusion criteria in phase III RCT with OS for those patients who did not. Furthermore, we analyzed the fraction of population-based cohort of newly diagnosed elderly and younger myeloma patients that fulfill the inclusion and exclusion criteria.

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Acknowledgements

The work was funded by The Research Fund at Rigshospitalet, Copenhagen.

Author contributions

TWK and AJV conceived and designed the work, interpreted the results, drafted the manuscript and approved the final version. HG, NA, NFA, UCF, PG, and CH interpreted the results, revised the manuscript and approved the final version.

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Authors and Affiliations

  1. Department of Hematology, Herlev Hospital, Herlev, Denmark

    Tobias W. Klausen & Carsten Helleberg

  2. Department of Hematology, Aalborg University Hospital, Aalborg, Denmark

    Henrik Gregersen

  3. Department of Hematology, Odense University Hospital, Odense, Denmark

    Niels Abildgaard

  4. Department of Hematology, Aarhus University Hospital, Aarhus, Denmark

    Niels Frost Andersen

  5. Department of Hematology, Roskilde Hospital, Roskilde, Denmark

    Ulf Christian Frølund

  6. Department of Hematology, Rigshospitalet, Copenhagen, Denmark

    Peter Gimsing & Annette J. Vangsted

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  1. Tobias W. Klausen
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Correspondence to Annette J. Vangsted.

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Klausen, T.W., Gregersen, H., Abildgaard, N. et al. The majority of newly diagnosed myeloma patients do not fulfill the inclusion criteria in clinical phase III trials. Leukemia 33, 546–549 (2019). https://doi.org/10.1038/s41375-018-0272-0

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