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Review
. 2025 Aug 8;7(3):36-59.
doi: 10.46989/001c.141401. eCollection 2025.

Consensus Guidelines and Recommendations for the anti-CD38-based Therapy in Clinical Practice for Relapsed/Refractory Multiple Myeloma: From the Pan-Pacific Multiple Myeloma Working Group

Wenming Chen  1 , Zhen Cai  2 , Chor Sang Chim  3 , Wee Joo Chng  4 , Juan Du  5 , Chengcheng Fu  6 , Wen Gao  7 , Ichiro Hanamura  8 , Jian Hou  9 , Jeffrey Shang-Yi Huang  10 , Tadao Ishida  11 , Chunrui Li  12 , Aijun Liu  7 , Vadim Ptushkin  13 , Naoki Takezako  14 , Raymond Siu Ming Wong  15 , Dok Hyun Yoon  16
Affiliations
Review

Consensus Guidelines and Recommendations for the anti-CD38-based Therapy in Clinical Practice for Relapsed/Refractory Multiple Myeloma: From the Pan-Pacific Multiple Myeloma Working Group

Wenming Chen et al. Clin Hematol Int. .

Abstract

Anti-CD38 monoclonal antibodies (mAbs), including daratumumab and isatuximab, have become key components of treatment for relapsed/refractory multiple myeloma (RRMM). This expert consensus provides evidence-based guidance on their optimal use, including regimen selection, special considerations for elderly or frail patients, and the treatment of high-risk subgroups. Key topics addressed include the selection of anti-CD38-based regimens, patient stratification by frailty and comorbidities, strategies for managing hematologic toxicities, and considerations for re-treatment. Anti-CD38 mAb-based regimens have demonstrated clinical efficacy across diverse RRMM populations, including patients with high-risk cytogenetic abnormalities such as 1q21+. While resistance remains a clinical challenge, particularly in previously exposed patients, current evidence supports the feasibility of anti-CD38 mAb rechallenge following a substantial washout period (typically 6 to 12 months), which may allow partial recovery of CD38 expression and immune effector function. The consensus also emphasizes the continued utility of these agents in elderly or frail individuals, where durable responses can be achieved with appropriate monitoring and supportive care. Moreover, anti-CD38 mAbs are recognized as key components within evolving treatment paradigms, supporting their use for combination strategies involving emerging immunotherapies such as CAR-T cells and bispecific antibodies. This consensus provides a framework to guide individualized treatment decisions and highlights the need for continued research to optimize the integration of anti-CD38 mAbs into the modern therapeutic landscape of RRMM.

Keywords: Anti-CD38 monoclonal antibody; Daratumumab; Isatuximab; Relapsed or refractory multiple myeloma; Triplet therapy.

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Conflict of interest statement

WJC has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from J&J, Sanofi, BMS, GSK, Takeda, and Regeneron, and stock or stock options from Kyan Technologies and Medicia.ai. IH has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Takeda, BMS, Ono, Janssen, Sanofi, and Pfizer. TI has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Takeda, BMS, Ono, CSL Behring, Janssen, Sanofi, and Pfizer. RSMW has received medical writing support from Sanofi, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Bistol-Myer-Squibb, GSK, Sanofi, Pfizer, Novartis, and AstraZeneca, and support for attending meetings and/or travel from Beigene, Sanofi, and Novartis, and participation on a Data Safety Monitoring Board or Advisory Board from Novartis, J&J, GSK, Sanofi, and Roche. DHY has received grants or contracts from any entity from Abbvie, BeOne, Boryung, Celltrion, Kyowa Kirin, Janssen, Samyang, and Sanofi, and consulting fees from Abclon, BeOne, BMS, GI Cell, GC Cell, Verismo, J&J, Novartis, and Roche, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from BMS, Boryung, GSK, Kyowa Kirin, Novartis, Roche, Takeda, and J&J, and patents planned, issued, or pending from Boryung. WC, ZC, CSC, JD, CF, WG, JH, JSYH, CL, AL, VP, and NT have declared no conflicts of interest.

References

    1. Multiple Myeloma. Palumbo A., Anderson K. 2011New England Journal of Medicine. 364(11):1046–1060. doi: 10.1056/NEJMra1011442. https://doi.org/https://doi.org/10.1056/NEJMra1011442 - DOI - PubMed
    1. Multiple myeloma epidemiology and survival: A unique malignancy. Kazandjian D. 2016Seminars in Oncology. 43(6):676–681. doi: 10.1053/j.seminoncol.2016.11.004. https://doi.org/10.1053/j.seminoncol.2016.11.004 - DOI - PMC - PubMed
    1. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Rajkumar S. V.., et al. 2014The lancet oncology. 15(12):e538–e548. doi: 10.1016/s1470-2045(14)70442-5. https://doi.org/https://doi.org/10.1016/s1470-2045(14)70442-5 - DOI - PubMed
    1. Cancer statistics, 2023. Siegel R. L.., et al. 2023CA: a cancer journal for clinicians. 73(1):17–48. doi: 10.3322/caac.21763. https://doi.org/https://doi.org/10.3322/caac.21763 - DOI - PubMed
    1. Evolving strategies in the management of transplant-eligible patients with newly diagnosed multiple myeloma. Perrot A. 2025La Presse Médicale. 54(1):104262. doi: 10.1016/j.lpm.2024.104262. https://doi.org/10.1016/j.lpm.2024.104262 - DOI - PubMed

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