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Clarification of the definition of complete response in multiple myeloma

Leukemia volume 29, pages 2416–2417 (2015)Cite this article

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In 2006, the International Myeloma Working Group (IMWG) published uniform response criteria for multiple myeloma (MM).1, 2 These criteria with a minor clarifications have been widely used to measure the effectiveness of myeloma therapy clinical trials.3 The development of effective monoclonal antibodies for the treatment of MM, such as elotuzumab and daratumumab have brought to our attention an urgent problem in which patients achieving complete response (CR) can be erroneously classified using the IMWG criteria.

As currently written, CR in MM requires negative immunofixation for monoclonal (M) protein in the serum and urine. The intended purpose of this requirement was to demonstrate that the M protein secreted by MM cells is no longer detectable (Table 1). We are now aware that new monoclonal antibodies developed for the treatment of MM (e.g., daratumumab and elotuzumab) interfere with the assay by immunofixation since they appear as M proteins on immunofixation. An abnormal immunofixation result due to interference of the assay by a therapeutically administered M protein was not foreseen by us.

Table 1 Clarification of the definition of complete response in multiple myeloma
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References

  1. Durie BGM, Harousseau J-L, Miguel JS, Blade J, Barlogie B, Anderson K et al. International uniform response criteria for multiple myeloma. Leukemia 2006; 20: 1467–1473.

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  2. Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K et al. International uniform response criteria for multiple myeloma (corrigenda/erratum). Leukemia 2007; 21: 1134.

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Authors and Affiliations

  1. Cedars-Sinai Comprehensive Cancer Center, Los Angeles, CA, USA

    B G M Durie

  2. Clinica Universidad de Navarra, Centro de Investigacion Medica Aplicada (CIMA), IDISNA, Pamplona, Spain

    J F S Miguel

  3. Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

    J Blade

  4. Division of Hematology, Mayo Clinic, Rochester, MN, USA

    S V Rajkumar

Authors
  1. B G M Durie
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  2. J F S Miguel
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  3. J Blade
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  4. S V Rajkumar
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on behalf of the International Myeloma Working Group

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Correspondence to B G M Durie.

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Competing interests

BGMD has been on the independent review committees for Onyx, Janssen and Takeda. JFSM has been on the advisory committees for Janssen, Bristol-Myers Squibb, Sanofi, Millennium, Celgene, Novartis and Onyx. JB has received honoraria for lectures from Janssen and honoraria for advisory boards from Janssen and Bristol Meyers Squibb. The remaining authors declare no conflict of interest.

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Durie, B., Miguel, J., Blade, J. et al. Clarification of the definition of complete response in multiple myeloma. Leukemia 29, 2416–2417 (2015). https://doi.org/10.1038/leu.2015.290

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