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Daratumumab in multiple myeloma: experience of the multiple myeloma GIMEMA Lazio group

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Abstract

Daratumumab (DARA) is a human IgG-K monoclonal antibody (MoAb) targeting CD38 that is approved alone or in combination with bortezomib and dexamethasone or lenalidomide and dexamethasone for relapsed or refractory MM (RRMM) in patients previously exposed or double refractory to proteasome inhibitors (PI) and immunomodulatory drugs (IMiDs). However, there are limited data on its clinical activity and tolerability in real-world patients. Therefore, in the present study, we aim to determine the efficacy and toxicity profile of daratumumab in a real-life setting. In this study, we report the experience of the multiple myeloma GIMEMA Lazio Group in 62 relapsed/refractory MM patients treated with daratumumab as monotherapy who had previously received at least two treatment lines including a PI and an IMiDs or had been double refractory. Patients received DARA 16 mg/kg intravenously weekly for 8 weeks, every 2 weeks for 16 weeks, and every 4 weeks until disease progression or unacceptable toxicity. The overall response rate to daratumumab was 46%. Median progression-free survival (PFS) and overall survival reached 2.7 and 22.4 months, respectively. DARA was generally well tolerated; however, 2 patients interrupted their therapy due to adverse events. Present real-life experience confirms that DARA monotherapy is an effective strategy for heavily pre-treated and refractory patients with multiple myeloma, with a favorable safety profile.

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Authors and Affiliations

  1. Multiple Myeloma GIMEMA Lazio Group, Via Casilina 5, 00182, Rome, Italy

    Federico Vozella, A. Siniscalchi, M. Rizzo, T. Za, G. Antolino, U. Coppetelli, A. Piciocchi, A. Andriani, O. Annibali, L. De Rosa, G. Cimino, G. La Verde, V. De Stefano, M. Cantonetti, T. Caravita di Toritto & M. T. Petrucci

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  1. Federico Vozella
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  2. A. Siniscalchi
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  3. M. Rizzo
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  4. T. Za
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  5. G. Antolino
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  6. U. Coppetelli
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  7. A. Piciocchi
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  8. A. Andriani
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  9. O. Annibali
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  10. L. De Rosa
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  11. G. Cimino
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  12. G. La Verde
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  13. V. De Stefano
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  14. M. Cantonetti
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  16. M. T. Petrucci
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Corresponding author

Correspondence to Federico Vozella.

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This article does not contain any studies with human participants or animals performed by any of the authors.

Conflict of interest

  • F. Vozella has received grants/speaker honorarium from Amgen, Celgene, Takeda;

  • Siniscalchi declares that she has no conflict of interest;

  • M. Rizzo declares that she has no conflict of interest;

  • T. Za declares that he has no conflict of interest;

  • G. Antolino has received grants/speaker honorarium from Amgen, BMS, Celgene, Janssen-Cilag, Takeda;

  • U. Coppetelli declares that he has no conflict of interest;

  • Piciocchi declares that he has no conflict of interest;

  • Andriani has received grants/speaker honorarium from Abbvie, Celgene, Janssen-Cilag, Takeda;

  • O. Annibali has received grants/speaker honorarium from Amgen, Celgene, Janssen-Cilag, Roche, Takeda;

  • L. De Rosa has received grants/speaker honorarium from Amgen, Celgene, Janssen-Cilag, Roche, Takeda;

  • G. Cimino declares that he has no conflict of interest;

  • G. La Verde has received grants/speaker honorarium from Amgen, BMS, Celgene, Janssen-Cilag, Takeda;

  • V. De Stefano has received grants/speaker honorarium from AIFA, Alexion, Amgen, Bayer, Catholic University School of Medicine, Celgene, Janssen-Cilag, Novartis, Takeda;

  • M. Cantonetti has received grants/speaker honorarium from Gilead, Incyte, Janssen-Cilag, Kyowa Kirin, Mundipharma, Roche, Sandoz, Takeda, Vifor;

  • T. Caravita di Toritto has received grants/speaker honorarium from Amgen, Celgene, Janssen-Cilag, Takeda;

  • M.T. Petrucci has received grants/speaker honorarium from Amgen, Celgene, Janssen-Cilag, Takeda.

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Vozella, F., Siniscalchi, A., Rizzo, M. et al. Daratumumab in multiple myeloma: experience of the multiple myeloma GIMEMA Lazio group. Ann Hematol 100, 1059–1063 (2021). https://doi.org/10.1007/s00277-020-04374-y

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  • DOI: https://doi.org/10.1007/s00277-020-04374-y

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