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3782 Efficacy of Isa-Pom-Dex Therapy in Double Refractory Multiple Myeloma (MM) Patients in Real Clinical Practice

Program: Oral and Poster Abstracts
Session: 907. Outcomes Research: Plasma Cell Disorders: Poster II
Hematology Disease Topics & Pathways:
Research, Adult, Epidemiology, Clinical Research, Real-world evidence, Registries, Study Population, Human
Sunday, December 8, 2024, 6:00 PM-8:00 PM

Maxim Soloviev, MD, PhD1*, Larisa Mendeleeva, MD, PhD2*, Maiia Soloveva, MD, PhD2*, Tatiana Ianovna Pospelova, MD, PhD3*, Natalia Skvortsova, MD, PhD4*, Elena Volodicheva, MD, PhD5*, Evgenia Zhelnova, MD, PhD6*, Elena Kirillova, MD7*, Marina Kiseleva, MD8*, Alina Chuprakova, MD9*, Varvara Bahtina, MD10*, Galina Kuchma, MD, PhD11*, Oksana Ochirova, MD12*, Sergey Voloshin, MD, PhD13*, Andrey Garifullin, MD14*, Tatiana Mitina, MD, PhD15*, Galina Dudina, MD, PhD16*, Victoriya Abramova, MD17*, Tatyana Olkhovik, MD18*, Marina Zakharova, MD19*, Ilya Usankin, MD20*, Nadezhda Medvedeva, MD, PhD21*, Viktoria Ryabchikova, MD, PhD21*, Anastasiya Semenova, MD, PhD22*, Anna Kopylova, MD23*, Natalya Solovkova, MD24*, Marina Demchenkova, MD, PhD25*, Tatyana Tsyganok, MD26*, Yulia Gammershmidt, MD27* and Olesya Kuznetsova, MD28*

1National Medical Research Center for Hematology, Moscow, Russia
2National Medical Research Center for Hematology, Moscow, Russian Federation
3Medical State University, Novosibirsk, RUS
4Medical State University, Novosibirsk, Russian Federation
5Regional Clinical Hospital, Tula, Russian Federation
6City Clinical Hospital No. 52, Moscow, Russian Federation
7Regional Clinical Hospital, Omsk, Russian Federation
8Regional Clinical Hospital, Simferopol, Russian Federation
9Regional Clinical Hospital, Kaliningrad, RUS
10Regional Clinical Hospital, Krasnoyarsk, Russian Federation
11Department of Faculty Therapy and Endocrinology, Orenburg State Medical University, Orenburg, Russian Federation
12Regional Clinical Hospital, Ulan-Ude, AL, RUS
13FMBA, Russian Scientific and Research Institute of Hematology and Transfusiology, St Petersburg, Russian Federation
14Russian Research Institute of Hematology and Transfusiology, Saint-Petersburg, Russian Federation
15Moscow Regional Scientific Research Clinical Institute named after. M. F. Vladimirsky, Moscow, Russian Federation
16Moscow Clinical Scientific Center named after A.S. Loginov, Moscow, Russian Federation
17Regional Clinical Hospital, Vladimir, Russian Federation
18Interdistrict Clinical Hospital №7, Krasnoyarsk, Russian Federation
19City Clinical Hospital №1, Chelyabinsk, Russian Federation
20Central City Hospital №7, Yekaterinburg, Russian Federation
21City Clinical Hospital №31, Saint-Petersburg, Russian Federation
22The Blokhin National Medical Research Center of Oncology of the Russian Ministry of Health, Moscow, RUS
23Regional Oncology Dispensary, Lipetsk, Russian Federation
24Regional Clinical Hospital, Irkutsk, Russian Federation
25regional oncology clinic, Irkutsk, Russian Federation
26Regional Clinical Hospital, Yuzhno-Sakhalinsk, Russian Federation
27Regional Clinical Hospital, Tomsk, Russian Federation
28City Clinical Hospital No. 29 named after A.A Lutsik, Novokuznetsk, Russian Federation

Background: Data from real-life clinical practice studies provide additional information on the efficacy of new antitumor therapy regimens, including in patients who meet exclusion criteria for clinical trials: patients with comorbidity, advanced stages, the elderly and weakness, low GFR, and those on hemodialysis.

Aims: to evaluate the effectiveness of the IsaPomDex triplet in MM patients in real clinical practice, to determine the parameters of OS.

Patients and Methods: From 2021 to 2024, the prospective study included 83 MM patients from 26 centers aged 38 to 85 years (median 63), who received the IsaPomDex triplet for the treatment of another relapse. Glomerular filtration rate <60 ml/min was detected at the time of initiation of the isatuximab-based triplet in 17 (18%) patients, 2 of whom were on program hemodialysis. The median of previous therapy lines was 2 (1-6) - the majority of patients received bortezomib (99%) and lenalidomide (94%), daratumumab - 28%, carfilzomib 18%, pomalidomide - 10%, ixazomib - 8% and elotuzumab - 8%, auto-HSCT was performed in 43% of patients. The median time from diagnosis to initiation of isatuximab-based triplet therapy was 47 months (5–203). Treatment efficacy, outcomes (relapse, progression, death), and adverse events were analyzed. Survival curves were constructed using the Kaplan-Meier method. Statistical analysis was done using Statistica 10.

Results: Analysis of the use of IsaPomDex regimen in real clinical practice in 26 centers demonstrated that triplet therapy was characterized by achieving an overall response in 76%, renal response in 61% of cases. The median PFS was 13.5 months, when the triplet was prescribed in the second line the median PFS was not achieved, in the case of using the combination in the third line - 14.3 months. In the group of patients who did not receive daratumumab at previous stages, the median PFS was significantly higher and was 28 months vs 8 months (p < 0.05). 3-year OS was 81%. Experience with the IsaPomDex regimen demonstrates good tolerability - the most common hematological AE was neutropenia - 70%, grade 4 - 17%. Discontinuation of isatuximab due to the development of AE was recorded in 2 cases (2%). The IsaPomDex combination was administered to 2 patients with stage 5 CKD who were receiving renal replacement therapy; no significant increase in the incidence of AEs was observed. In the group of patients with intraosseous components (n=46), IsaPomDex therapy was characterized by achieving a general response in 67% of cases, 12-month PFS was 48%, and 1-year OS was 76%.

Conclusion: The results of the study of real clinical practice on the use of IsaPomDex triplet for the treatment of relapsed MM showed data comparable to the ICARIA registration study on the frequency of achieving a response, duration of PFS and OS. At the same time, the effectiveness of the triplet was shown in elderly and weakened patients, with advanced stages and those undergoing renal replacement therapy.

Disclosures: Voloshin: Sanofi: Honoraria; Astra Zeneca: Honoraria; Novartis: Honoraria, Other: non-financial clinical trial support; BIOCAD: Other: non-financial clinical trial support; Abbvie: Honoraria, Other: non-financial clinical trial support; Janssen: Honoraria, Other: non-financial clinical trial support; BieGene: Other: non-financial clinical trial support.

*signifies non-member of ASH