Efficacy of IsaPomDex triplet therapy in double refractory multiple myeloma patients in real clinical practice in Russia

M. V. Solovev; Соловьев М. В.; M. V. Solovevа; Соловьева М. В.; L. P. Mendeleeva; Менделеева Л. П.; T. I. Pospelova; Поспелова Т. И.; N. V. Skvortsova; Скворцова Н. В.; S. V. Voloshin; Волошин С. В.; A. D. Garifullin; Гарифуллин А. Д.; A. S. Chuprakova; Чупракова А. С.; T. A. Mitina; Митина Т. А.; I. S. Usankin; Усанкин И. С.; I. V. Vasileva; Васильева И. В.; N. V. Medvedeva; Медведева Н. В.; V. V. Ryabchikova; Рябчикова В. В.; M. Ya. Kiseleva; Киселева М. Я.; G. A. Dudina; Дудина Г. А.; Yu. S. Gammershmidt; Гаммершмидт Ю. С.; O. S. Kuznetsova; Кузнецова О. С.; Yu. V. Dolgushina; Долгушина Ю. В.; G. B. Kuchma; Кучма Г. Б.; T. N. Tsyganok; Цыганок Т. Н.; E. N. Misyurina; Мисюрина Е. Н.; E. I. Zhelnova; Желнова Е. И.; A. V. Kopylova; Копылова А. В.; M. N. Zakharova; Захарова М. Н.; A. V. Korobkin; Коробкин А. В.; G. S. Tumyan; Тумян Г. С.; A. A. Semenova; Семенова А. А.; E. G. Kirillova; Кириллова Е. Г.; E. M. Volodicheva; Володичева Е. М.; V. I. Bakhtina; Бахтина В. И.; T. I. Olkhovik; Ольховик Т. И.; N. R. Solovkova; Соловкова Н. Р.; M. V. Demchenkova; Демченкова М. В.; O. E. Ochirova; Очирова О. Е.; O. L. Panteleeva; Пантелеева О. Л.; V. S. Abramova; Абрамова В. С.

doi:10.17650/1818-8346-2024-19-4-115-123

Efficacy of IsaPomDex triplet therapy in double refractory multiple myeloma patients in real clinical practice in Russia

Authors: Solovev M.V.¹, Solovevа M.V.¹, Mendeleeva L.P.¹, Pospelova T.I.², Skvortsova N.V.², Voloshin S.V.³, Garifullin A.D.⁴, Chuprakova A.S.⁵, Mitina T.A.⁶, Usankin I.S.⁷, Vasileva I.V.⁷, Medvedeva N.V.⁸, Ryabchikova V.V.⁸, Kiseleva M.Y.⁹, Dudina G.A.¹⁰, Gammershmidt Y.S.¹¹, Kuznetsova O.S.¹², Dolgushina Y.V.¹², Kuchma G.B.¹³, Tsyganok T.N.¹⁴, Misyurina E.N.¹⁵, Zhelnova E.I.¹⁵, Kopylova A.V.¹⁶, Zakharova M.N.¹⁷, Korobkin A.V.¹⁸, Tumyan G.S.¹⁹, Semenova A.A.¹⁹, Kirillova E.G.²⁰, Volodicheva E.M.²¹, Bakhtina V.I.²⁰, Olkhovik T.I.²², Solovkova N.R.²³, Demchenkova M.V.²⁴, Ochirova O.E.²⁵, Panteleeva O.L.²⁰, Abramova V.S.²⁰
Affiliations:
1. National Medical Research Center for Hematology, Ministry of Health of Russia
2. Novosibirsk State Medical University, Ministry of Health of Russia
3. Leningrad Regional Clinical Hospital
4. Russian Research Institute of Hematology and Transfusiology, Federal Medical and Biological Agency
5. Central City Clinical Hospital
6. M.F. Vladimirskiy Moscow Regional Research Clinical Institute
7. Central City Hospital No. 7
8. City Clinical Hospital No. 31
9. N.A. Semashko Republican Clinical Hospital
10. A.S. Loginov Moscow Clinical Scientific Center, Moscow Healthcare Department
11. Tomsk Regional Clinical Hospital
12. A.A. Lutsik Novokuznetsk City Clinical Hospital No. 29
13. V.I. Voynov Orenburg Regional Clinical Hospital
14. Sakhalin Regional Clinical Hospital
15. Moscow City Clinical Hospital No. 52
16. Lipetsk Regional Oncological Dispensary
17. Chelyabinsk City Clinical Hospital No. 1
18. Chelyabinsk Regional Clinical Hospital
19. N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
20. Regional Clinical Hospital
21. Tula Regional Clinical Hospital
22. Krasnoyarsk Interdistrict Clinical Hospital No. 7
23. Irkutsk Regional Clinical Hospital
24. Irkutsk Regional Oncology Dispensary
25. N.A. Semashko Republican Clinical Hospital, Ministry of Health of the Republic of Buryatia
Issue: Vol 19, No 4 (2024)
Pages: 115-123
Section: RARE AND COMPLEX CLINICAL SITUATIONS: DIAGNOSIS AND TREATMENT CHOICE
Published: 10.12.2024
URL: https://oncohematology.abvpress.ru/ongm/article/view/979
DOI: https://doi.org/10.17650/1818-8346-2024-19-4-115-123
ID: 979

Cite item

Full Text

Abstract
About the authors
References
Supplementary files
Statistics

Abstract

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.

Aim. To evaluate the Isaomex triplet efficacy in multiple myeloma patients in real clinical practice.

Materials and methods. From 2021 to 2024, the retrospective study included 83 double refractory multiple myeloma patients from 26 centers aged 38 to 85 years (median 63), who received the Isaomex triplet. Glomerular filtration rate ˂ 60 mL/min was detected at the time of isatuximabbased triplet initiation in 18 % patients, 2 of whom were on program hemodialysis. The median of previous therapy lines was 2 (1–6). The median time from diagnosis to initiation of isatuximabbased triplet therapy was 47 months (5–203). Survival curves were constructed using the Kaplan–Meier method. Statistical analysis was performed using Statistica 10 program.

Results. Isaomex triplet therapy resulted in overall and renal responses in 76 % and 61 % of cases, respectively. The median progression free survival was 13.5 months. In the group of patients who did not receive daratumumab at previous stages, the median progression free survival was significantly higher and was 28 months vs 8 months (p ˂ 0.05). Threeyear overall survival was 81 %. Discontinuation of isatuximab due to the development of adverse event was recorded in 2 cases (2 %). In the group of patients with bone plasmacytomas (n = 46), Isaomex therapy resulted in an overall response rate of 67 %; 12‑month progression free survival was 48 %, and 1‑year overall survival was 76 %.

Conclusion. The results of the Isaomex triplet use in real clinical practice for the treatment of relapsed multiple myeloma showed data comparable to the ICARIA registration study on the frequency of achieving a response, duration of progression free survival and overall survival. The triplet efficiency was shown in comorbid patients, with advanced stages and those undergoing renal replacement therapy.

Keywords

relapsed or refractory multiple myeloma, monoclonal antibody isatuximab, Isaomex triplet

About the authors

M. V. Solovev

National Medical Research Center for Hematology, Ministry of Health of Russia

Author for correspondence.
Email: maxsolovej@mail.ru
ORCID iD: 0000-0002-7944-6202

4 Novyy Zykovskiy Proezd, Moscow 125167

Russian Federation

M. V. Solovevа

National Medical Research Center for Hematology, Ministry of Health of Russia

ORCID iD: 0000-0003-4142-171X

4 Novyy Zykovskiy Proezd, Moscow 125167

Russian Federation

L. P. Mendeleeva

National Medical Research Center for Hematology, Ministry of Health of Russia

ORCID iD: 0000-0002-4966-8146

4 Novyy Zykovskiy Proezd, Moscow 125167

Russian Federation

T. I. Pospelova

Novosibirsk State Medical University, Ministry of Health of Russia

ORCID iD: 0000-0002-1261-5470

52 Krasnyy Prospekt, Novosibirsk 630091

Russian Federation

N. V. Skvortsova

Novosibirsk State Medical University, Ministry of Health of Russia

ORCID iD: 0000-0001-6938-3802

52 Krasnyy Prospekt, Novosibirsk 630091

Russian Federation

S. V. Voloshin

Leningrad Regional Clinical Hospital

ORCID iD: 0000-0003-1784-0375

Build. 2A, 45 Lunacharskogo Prospekt, St. Petersburg 194291

Russian Federation

A. D. Garifullin

Russian Research Institute of Hematology and Transfusiology, Federal Medical and Biological Agency

ORCID iD: 0000-0003-0946-383X

16 2nd Sovetskaya St., Saint Petersburg 191024

Russian Federation

A. S. Chuprakova

Central City Clinical Hospital

ORCID iD: 0009-0003-3438-1294

3 Letnyaya St., Kaliningrad 236005

Russian Federation

T. A. Mitina

M.F. Vladimirskiy Moscow Regional Research Clinical Institute

ORCID iD: 0000-0001-7493-0030

61/2 Shchepkina St., Moscow 129110

Russian Federation

I. S. Usankin

Central City Hospital No. 7

ORCID iD: 0009-0008-1865-9547

33 Vilonova St., Ekaterinburg 620137

Russian Federation

I. V. Vasileva

Central City Hospital No. 7

ORCID iD: 0000-0001-6597-4752

33 Vilonova St., Ekaterinburg 620137

Russian Federation

N. V. Medvedeva

City Clinical Hospital No. 31

ORCID iD: 0000-0002-4350-4204

3 Prospekt Dinamo, Saint Petersburg 197110

Russian Federation

V. V. Ryabchikova

City Clinical Hospital No. 31

3 Prospekt Dinamo, Saint Petersburg 197110

Russian Federation

M. Ya. Kiseleva

N.A. Semashko Republican Clinical Hospital

ORCID iD: 0009-0006-4444-7228

69 Kievskaya St., Simferopol 295017

Russian Federation

G. A. Dudina

A.S. Loginov Moscow Clinical Scientific Center, Moscow Healthcare Department

ORCID iD: 0000-0001-9673-1067

1 Novogireevskaya St., Moscow 111123

Russian Federation

Yu. S. Gammershmidt

Tomsk Regional Clinical Hospital

ORCID iD: 0000-0001-6968-7064

96 I. Chernykh St., Tomsk 634063

Russian Federation

O. S. Kuznetsova

A.A. Lutsik Novokuznetsk City Clinical Hospital No. 29

ORCID iD: 0009-0006-1165-452X

49 Sovetskoy Armii Prospekt, Novokuznetsk 654038

Russian Federation

Yu. V. Dolgushina

A.A. Lutsik Novokuznetsk City Clinical Hospital No. 29

ORCID iD: 0009-0005-4416-962X

49 Sovetskoy Armii Prospekt, Novokuznetsk 654038

Russian Federation

G. B. Kuchma

V.I. Voynov Orenburg Regional Clinical Hospital

ORCID iD: 0000-0002-2063-8859

23 Aksakova St., Orenburg 460018

Russian Federation

T. N. Tsyganok

Sakhalin Regional Clinical Hospital

ORCID iD: 0009-0009-3625-8779

430 Mira Prospekt, Yuzhno-Sakhalinsk 693004

Russian Federation

E. N. Misyurina

Moscow City Clinical Hospital No. 52

ORCID iD: 0000-0003-2419-4850

Build. 3, 3 Pekhotnaya St., Moscow 123182

Russian Federation

E. I. Zhelnova

Moscow City Clinical Hospital No. 52

ORCID iD: 0000-0002-0343-9348

Build. 3, 3 Pekhotnaya St., Moscow 123182

Russian Federation

A. V. Kopylova

Lipetsk Regional Oncological Dispensary

ORCID iD: 0009-0003-1271-4940

1e Admirala Makarova St., Lipetsk 398005

Russian Federation

M. N. Zakharova

Chelyabinsk City Clinical Hospital No. 1

ORCID iD: 0009-0001-4324-3235

16 Vorovskogo St., Chelyabinsk 454092,

Russian Federation

A. V. Korobkin

Chelyabinsk Regional Clinical Hospital

ORCID iD: 0000-0003-4922-3742

70 Vorovskogo St., Chelyabinsk 454048

Russian Federation

G. S. Tumyan

N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia

ORCID iD: 0000-0002-5771-4413

24 Kashirskoe Shosse, Moscow 115522

Russian Federation

A. A. Semenova

N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia

ORCID iD: 0000-0003-4951-3053

24 Kashirskoe Shosse, Moscow 115522

Russian Federation

E. G. Kirillova

Regional Clinical Hospital

ORCID iD: 0009-0005-9602-2208

3 Berezovaya St., Omsk 644012

Russian Federation

E. M. Volodicheva

Tula Regional Clinical Hospital

1a Yablochkova St., Tula 300053

Russian Federation

V. I. Bakhtina

Regional Clinical Hospital

ORCID iD: 0000-0002-6465-9942

3a Partizana Zheleznyaka St., Krasnoyarsk 660022

Russian Federation

T. I. Olkhovik

Krasnoyarsk Interdistrict Clinical Hospital No. 7

ORCID iD: 0000-0002-4526-1920

4 Akademika Pavlova St., Krasnoyarsk 660003

Russian Federation

N. R. Solovkova

Irkutsk Regional Clinical Hospital

ORCID iD: 0009-0008-8283-6210

29 Karla Marksa St., Irkutsk 664003

Russian Federation

M. V. Demchenkova

Irkutsk Regional Oncology Dispensary

ORCID iD: 0000-0001-6606-1154

32 Frunze St., Irkutsk 664035

Russian Federation

O. E. Ochirova

N.A. Semashko Republican Clinical Hospital, Ministry of Health of the Republic of Buryatia

ORCID iD: 0000-0002-0145-3226

12 Pavlova St., Ulan-Ude 670047

Russian Federation

O. L. Panteleeva

Regional Clinical Hospital

ORCID iD: 0000-0002-6616-656X

41 Sudogodskoye Shosse, Vladimir 600023

Russian Federation

V. S. Abramova

Regional Clinical Hospital

ORCID iD: 0009-0006-9601-7502

41 Sudogodskoye Shosse, Vladimir 600023

Russian Federation

References

Martin T.G., Corzo K., Chiron M. et al. Therapeutic opportunities with pharmacological inhibition of CD38 with isatuximab. Cells 2019;8(12):1522. doi: 10.3390/cells8121522
Martin T., Strickland S., Glenn M. et al. Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma. Blood Cancer J 2019;9(4):41. doi: 10.1038/s4140801901984
Attal M., Richardson P.G., Rajkumar S.V. et al. Isatuximab plus pomalidomide and lowdose dexamethasone versus pomalidomide and lowdose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIAMM): a randomised, multicentre, openlabel, phase 3 study [published correction appears in Lancet 2019;394(10214):2072]. Lancet 2019;394(10214):2096–107. doi: 10.1016/S01406736(19)325565
Richardson P.G., Perrot A., SanMiguel J. et al. Isatuximab plus pomalidomide and lowdose dexamethasone versus pomalidomide and lowdose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIAMM): followup analysis of a randomised, phase 3 study [published correction appears in Lancet Oncol 2022;23(9):e404]. Lancet Oncol 2022;23(3):416–27. doi: 10.1016/S14702045(22)000195
Takakuwa T., Ohta K., Sogabe N. et al. Isatuximab plus pomalidomide and dexamethasone in a patient with dialysis dependent multiple myeloma. Chemotherapy 2021;66(5–6):192–5. doi: 10.1159/000519783
Dimopoulos M.A., Leleu X., Moreau P. et al. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIAMM subgroup analysis. Leukemia 2021;35(2):562–72. doi: 10.1038/s413750200868z
Zweegman S., Engelhardt M., Larocca A. Elderly patients with multiple myeloma: towards a frailty approach? Curr Opin Oncol 2017;29(5):315–21. doi: 10.1097/CCO.0000000000000395
Shah J.J., Abonour R., Gasparetto C. et al. Analysis of common eligibility criteria of randomized controlled trials in newly diagnosed multiple myeloma patients and extrapolating outcomes. Clin Lymphoma Myeloma Leuk 2017;17(9):575–83.e2. doi: 10.1016/j.clml.2017.06.013
Djebbari F., Rampotas A., Vallance G. et al. Efficacy of isatuximab with pomalidomide and dexamethasone in relapsed myeloma: results of a UKwide realworld dataset. HemaSphere 2022;6(6):e738. doi: 10.1097/HS9.0000000000000738
Decaux O., Fontan J., Perrot A. et al. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/ refractory multiple myeloma in realworld: the retrospective IMAGE study. Eur J Haematol 2024;113(3):290–7. doi: 10.1111/ejh.14225
Manasanch E.E., Beksac M., Cavo M. et al. MM086 realworld experience with isatuximab (Isa) in patients with relapsed and/or refractory multiple myeloma: IONAMM first interim analysis. Clin Lymphoma Myeloma Leuk 2022;22:S405–6. doi: 10.1016/S21522650(22)015907
Dimopoulos M., Weisel K., van de Donk N.W.C.J. et al. Pomalidomide plus lowdose dexamethasone in patients with relapsed/refractory multiple myeloma and renal impairment: results from a phase II trial. J Clin Oncol 2018;36(20):2035–43. doi: 10.1200/JCO.2017.76.1742
Yadav P., Cook M., Cockwell P. Current trends of renal impairment in multiple myeloma. Kidney Dis (Basel) 2016;1(4):241–57. doi: 10.1159/000442511
Kasserra C., Assaf M., Hoffmann M. et al. Pomalidomide: evaluation of cytochrome P450 and transportermediated drugdrug interaction potential in vitro and in healthy subjects. J Clin Pharmacol 2015;55(2):168–78. doi: 10.1002/jcph.384

Supplementary files

Supplementary Files

Action

1. JATS XML

Download

Username
Password
Remember me

Forgot password?	Register

Username
Password
Remember me

Forgot password?	Register