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Treatment of Bendamustine and Prednisone in patients with newly diagnosed multiple myeloma results in superior complete response rate, prolonged time to treatment failure and improved quality of life compared to treatment with Melphalan and Prednisone—a randomized phase III study of the East German Study Group of Hematology and Oncology (OSHO)

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Abstract

Purpose: This randomized phase III study compared bendamustine and prednisone (BP) to standard melphalan and prednisone (MP) treatment in previously untreated patients with multiple Myeloma (MM). Patients and Methods: To be included, patients had to have histologically and cytologically proven stage II with progressive diseases or stage III MM. They were randomly assigned to receive BP (n=68) or MP (n=63). The primary endpoint was the time to treatment failure (TTF). Secondary endpoints included survival, remission rate, toxicity and quality of life. Results: The overall response rate was 75% in the BP and 70% in the MP group. A significantly higher number of patients treated with BP achieved a complete remission than did patients receiving MP (32 vs. 13%; P=0.007), and the maximum response was achieved more rapidly in patients treated with BP compared to those receiving MP (6.8 vs. 8.7 cycles; P<0.02). TTF and remission duration were significantly longer in the BP group. Patients receiving BP had higher QoL scores and reported pain less frequently than patients receiving MP. Conclusion: BP is superior to MP with respect to complete remission rate, TTF, cycles needed to achieve maximum remission and quality of life and should be considered the new standard in first-line treatment of MM patients not eligible for transplantation.

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Acknowledgements

The authors wish to thank Barbara Hobbie for manuscript preparation, and all physicians, nurses, and support personnel for their care of patients on this study.

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Authors and Affiliations

  1. Department of Hematology and Oncology, University of Leipzig, Johannisallee 32A, 04103, Leipzig, Germany

    W. Pönisch, W. Helbig & D. Niederwieser

  2. Department of Hematology and Oncology, University of Frankfurt, Frankfurt, Germany

    P. S. Mitrou

  3. Ribosepharm GmbH, Munich, Germany

    K. Merkle

  4. Division of Hematology and Oncology, HELIOS Klinikum, Erfurt, Germany

    M. Herold & A. Schulze

  5. Hospital Riesa, Riesa, Germany

    M. Assmann

  6. Harz-Klinikum Wernigerode GmbH, Wernigerode, Germany

    G. Wilhelm

  7. Division of Hematology and Oncology, Südharz Hospital Nordhausen, Nordhausen, Germany

    K. Dachselt

  8. Community Hospital, Zella-Mehlis, Germany

    P. Richter

  9. Division of Hematology and Oncology, Vogtland-Klinikum Plauen, Plauen, Germany

    V. Schirmer

  10. Division of Hematology and Oncology, HELIOS Klinikum, Schwerin, Germany

    R. Šubert

  11. Division of Hematology and Oncology, Hospital Johann Kentmann, Torgau, Germany

    B. Harksel

  12. Division of Hematology and Oncology, Hospital Neu Brandenburg, Brandenburg, Germany

    N. Grobe

  13. Division of Hematology and Oncology, Waldklinikum Gera, Gera, Germany

    E. Stelzer

  14. Division of Hematology and Oncology, Hematology and Oncology Zittau, Zittau, Germany

    M. Schulze

  15. Hematology and Oncology, Erfurt, Germany

    A. Bittrich

  16. Division of Hematology and Oncology, University Rostock, Rostock, Germany

    M. Freund

  17. Division of Hematology and Oncology, Ernst von Bergmann Hospital Postdam, Postdam, Germany

    R. Pasold

  18. Institute of Patology, University Leipzig, Leipzig, Germany

    Th. Friedrich

Authors
  1. W. Pönisch
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  2. P. S. Mitrou
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  3. K. Merkle
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  4. M. Herold
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  5. M. Assmann
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  6. G. Wilhelm
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  7. K. Dachselt
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  8. P. Richter
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  9. V. Schirmer
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  10. A. Schulze
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  11. R. Šubert
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  12. B. Harksel
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  13. N. Grobe
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  14. E. Stelzer
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  15. M. Schulze
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  16. A. Bittrich
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  17. M. Freund
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  18. R. Pasold
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  19. Th. Friedrich
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  20. W. Helbig
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  21. D. Niederwieser
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Corresponding author

Correspondence to D. Niederwieser.

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Pönisch, W., Mitrou, P.S., Merkle, K. et al. Treatment of Bendamustine and Prednisone in patients with newly diagnosed multiple myeloma results in superior complete response rate, prolonged time to treatment failure and improved quality of life compared to treatment with Melphalan and Prednisone—a randomized phase III study of the East German Study Group of Hematology and Oncology (OSHO). J Cancer Res Clin Oncol 132, 205–212 (2006). https://doi.org/10.1007/s00432-005-0074-4

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  • DOI: https://doi.org/10.1007/s00432-005-0074-4

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