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Pomalidomide, dexamethasone, and daratumumab in Japanese patients with relapsed or refractory multiple myeloma after lenalidomide-based treatment

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Abstract

In cohort C of the phase 2 MM-014 trial, the efficacy and safety of pomalidomide, dexamethasone, and daratumumab therapy were investigated in 18 Japanese patients with relapsed/refractory multiple myeloma (RRMM) after their most recent regimen of lenalidomide-based therapy (NCT01946477). Patients received oral pomalidomide (4 mg daily), oral dexamethasone (20–40 mg weekly), and intravenously infused daratumumab (16 mg/kg). Median age was 67.5 years. All patients received prior lenalidomide per protocol; 89% received prior bortezomib. Twelve patients (67%) had lenalidomide-refractory disease, and 6 (33%) had lenalidomide-relapsed disease. Ten patients (56%) had only 1 prior treatment line. As of August 3, 2020, 15 patients (83%) were still on treatment; median follow-up was 8.1 months. Three patients (17%) discontinued treatment (2 for adverse events; 1 for major protocol deviation). Overall response rate (primary endpoint) was 83% (very good partial response or better, 61%). All patients had ≥ 1 grade 3/4 treatment-emergent adverse events, most commonly neutropenia (78%; febrile, 6%), leukopenia (28%), and lymphopenia (22%). Grade 3/4 infections occurred in 17%; 11% had pneumonia. In Japanese patients with RRMM, a triplet regimen of pomalidomide, dexamethasone, and daratumumab after early-line lenalidomide treatment failure showed high efficacy and safety consistent with the known safety profile.

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Data availability statement

The Bristol Myers Squibb policy on data sharing may be found at https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html.

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Acknowledgements

The authors thank the patients and families who made this study possible. We also thank the study investigators and the clinical teams who made this study possible. The study was funded and supported by Celgene, a Bristol-Myers Squibb Company. The authors acknowledge Alex Loeb, PhD, of Chrysalis Medical Communications for medical writing and editorial assistance in the preparation of this manuscript, which was funded by Bristol Myers Squibb.

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Authors and Affiliations

  1. Kameda Medical Center, Kamogawa, Japan

    Kosei Matsue

  2. National Hospital Organization Okayama Medical Center, Okayama, Japan

    Kazutaka Sunami

  3. National Hospital Organization Shibukawa Medical Center, Gunma, Japan

    Morio Matsumoto

  4. Kyoto Prefectural University of Medicine, Kyoto, Japan

    Junya Kuroda

  5. Toyohashi Municipal Hospital, Toyohashi, Japan

    Isamu Sugiura

  6. National Hospital Organization Kyushu Medical Center, Fukuoka, Japan

    Hiromi Iwasaki

  7. Bristol Myers Squibb, Princeton, NJ, USA

    Weiyuan Chung & Kim Lee

  8. Bristol Myers Squibb KK, Tokyo, Japan

    Shigeki Kuwayama & Mitsufumi Nishio

  9. Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

    Shinsuke Iida

Authors
  1. Kosei Matsue
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  10. Kim Lee
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Contributions

K. Matsue, K. Sunami, M. Matsumoto, J. Kuroda, S. Kuwayama, M. Nishio, K. Lee, and S. Iida contributed to the conceptualization and design of the study. Patient treatment and data collection were performed by K. Matsue, K. Sunami, M. Matsumoto, J. Kuroda, I. Sugiura, H. Iwasaki, and S. Iida. Data analysis was performed by W. Chung. All authors contributed to the interpretation of results and preparation of the manuscript. All authors have read and approved the final manuscript.

Corresponding author

Correspondence to Kosei Matsue.

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Conflict of interests

K. Matsue reported receiving travel funding from Celgene, a Bristol-Myers Squibb Company, and Janssen. K. Sunami reported honoraria and research funding from AbbVie, Alexion Pharma, Amgen Astellas, Bristol Myers Squibb, Celgene, a Bristol-Myers Squibb Company, Daiichi Sankyo, GlaxoSmithKline, Janssen, MSD, Novartis, Ono, Sanofi, and Takeda. M. Matsumoto reported honoraria from Janssen and Sanofi KK. J. Kuroda reported honoraria and research funding from AbbVie, Bristol Myers Squibb, Celgene, a Bristol-Myers Squibb Company, Chugai, Dainippon Sumitomo, Eizai, Janssen, Kyowa, Nippon Shinyaku, Ono, Otsuka, Sanofi, Sysmex, and Takeda. I. Sugiura reported no competing interests. H. Iwasaki reported research funding from Kyowa Kirin. W. Chung is an employee of Bristol Myers Squibb and has equity ownership in Bristol Myers Squibb. S. Kuwayama is an employee of Bristol Myers Squibb and has equity ownership in Bristol Myers Squibb. M. Nishio is an employee of Bristol Myers Squibb and has equity ownership in Bristol Myers Squibb. K. Lee is an employee of Bristol Myers Squibb and has equity ownership in Bristol Myers Squibb. S. Iida received honoraria and research funding from Celgene, a Bristol-Myers Squibb Company, Janssen, Takeda, Ono, Sanofi, and Daiichi Sankyo and research funding from Chugai, Bristol Myers Squibb, AbbVie, Kyowa Kirin, and GlaxoSmithKline.

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Matsue, K., Sunami, K., Matsumoto, M. et al. Pomalidomide, dexamethasone, and daratumumab in Japanese patients with relapsed or refractory multiple myeloma after lenalidomide-based treatment. Int J Hematol 116, 122–130 (2022). https://doi.org/10.1007/s12185-022-03338-4

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  • DOI: https://doi.org/10.1007/s12185-022-03338-4

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