ISSN (print) 1997-6933     ISSN (online) 2500-2139
Vol. 18 No. 2 (2025), LYMPHOID TUMORS
Vol. 18 No. 2 (2025)
LYMPHOID TUMORS

Anti-CD38 Antibodies in Monotherapy for Patients with Relapsed/Refractory Multiple Myeloma: Real-World Clinical Practice and Results of Clinical Trials

Published 01.04.2025
Margarita Andreevna Ulyanova
Leningrad Regional Clinical Hospital, 45 korp. 2A Lunacharskogo pr-t, Saint Petersburg, Russian Federation, 194291
https://orcid.org/0000-0003-4977-1482
V.I. Vorobyev
Leningrad Regional Clinical Hospital, 45 korp. 2A Lunacharskogo pr-t, Saint Petersburg, Russian Federation, 194291
https://orcid.org/0000-0002-2692-8961
L.A. Bychenkova
SP Botkin Moscow Multispecialty Research Clinical Center, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284
S.V. Semochkin
PA Gertsen Moscow Oncology Research Institute, branch of the NMRC of Radiology, 3 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284; NI Pirogov Russian National Research Medical University, 1 Ostrovityanova ul., Moscow, Russian Federation, 117997
https://orcid.org/0000-0002-8129-8114
2025-2
PDF_2025-18-2-145-152 (Russian)

Keywords

multiple myeloma
daratumumab
isatuximab
clinical trials
real-world clinical practice

How to Cite

Ulyanova M.A., Vorobyev V.I., Bychenkova L.A., Semochkin S.V. Anti-CD38 Antibodies in Monotherapy for Patients with Relapsed/Refractory Multiple Myeloma: Real-World Clinical Practice and Results of Clinical Trials. Clinical Oncohematology. 2025;(2):145–152. doi:10.21320/2500-2139-2025-18-2-145-152.
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Abstract

AIM. To assess the personal experience with the use of anti-CD38 monoclonal antibodies (mAb) for the treatment of relapsed/refractory multiple myeloma (R/R ММ) patients enrolled in the international clinical trials (CT) as well as those treated in real-world clinical practice (RWCP).

MATERIALS & METHODS. The present retrospective study includes 63 R/R ММ patients (43 men and 20 women) who received daratumumab or isatuximab monotherapy from 2016 to 2020. The age of patients was 44–80 years; the median time by the start of the therapy to be assessed was 65 years. The analyzed cohort included 24 patients enrolled in the international multi-center CTs (daratumumab IV was administered to 14, daratumumab SC was given to 5, and isatuximab IV was applied in 5 of them). In RWCP, all 39 patients received daratumumab IV. The median number of prior therapy lines in the total cohort was 4 (range 1–10), in the CT group it was 5 (range 2–10), and in the RWCP group it was 4 (range 1–7). Resistance to bortezomib and lenalidomide occurred essentially in all patients under this study.

RESULTS. With the follow-up median of 20 months (range 1–62 months), overall response was 50 % in the CT group and 29.3 % in the RWCP group (p = 0.094). The 2-year progression-free survival in these groups of patients was 16.7 and 2.6 %, respectively (p = 0.052). In the CT group, the 2-year overall survival was reported to be 54.2 ± 10.2 % (median 26.5 months) vs. 34.6 ± 7.8 % (median 17 months) in the RWCP group (hazard ratio 0.47; p = 0.022).

CONCLUSION. The outcomes of anti-CD38 mAb monotherapy in the RWCP group lag behind those in patients enrolled in the international multi-center CTs. Although approaches to R/R MM treatment continue to be improved, anti-CD38 mAb monotherapy provides a certain treatment niche for heavily pretreated patients with bone marrow hematopoietic exhaustion and cumulative organ toxicity in cases when administration of intensive triplets can cause hypertoxicity. Infusion-related reactions associated with daratumumab or isatuximab mostly occur on their first administration and are not worse than grade 1/2. A switch from IV to SC daratumumab shortens the administration time from a few hours to 3–5 minutes and considerably reduces the incidence of infusion-related reactions.

PDF_2025-18-2-145-152 (Russian)

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