Efficacy of IsaPomDex triplet therapy in double refractory multiple myeloma patients in real clinical practice in Russia
M. V. Solovev,
M. V. Solovevа,
L. P. Mendeleeva,
T. I. Pospelova,
N. V. Skvortsova,
S. V. Voloshin,
A. D. Garifullin,
A. S. Chuprakova,
T. A. Mitina,
I. S. Usankin,
I. V. Vasileva,
N. V. Medvedeva,
V. V. Ryabchikova,
M. Ya. Kiseleva,
G. A. Dudina,
Yu. S. Gammershmidt,
O. S. Kuznetsova,
Yu. V. Dolgushina,
G. B. Kuchma,
T. N. Tsyganok,
E. N. Misyurina,
E. I. Zhelnova,
A. V. Kopylova,
M. N. Zakharova,
A. V. Korobkin,
G. S. Tumyan,
A. A. Semenova,
E. G. Kirillova,
E. M. Volodicheva,
V. I. Bakhtina,
T. I. Olkhovik,
N. R. Solovkova,
M. V. Demchenkova,
O. E. Ochirova,
O. L. Panteleeva,
V. S. Abramova https://doi.org/10.17650/1818-8346-2024-19-4-115-123
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.
About the Authors
M. V. Solovev
National Medical Research Center for Hematology, Ministry of Health of Russia
Russian Federation
Russian Federation
4 Novyy Zykovskiy Proezd, Moscow 125167
M. V. Solovevа
National Medical Research Center for Hematology, Ministry of Health of Russia
Russian Federation
Russian Federation
4 Novyy Zykovskiy Proezd, Moscow 125167
L. P. Mendeleeva
National Medical Research Center for Hematology, Ministry of Health of Russia
Russian Federation
Russian Federation
4 Novyy Zykovskiy Proezd, Moscow 125167
T. I. Pospelova
Novosibirsk State Medical University, Ministry of Health of Russia
Russian Federation
Russian Federation
52 Krasnyy Prospekt, Novosibirsk 630091
N. V. Skvortsova
Novosibirsk State Medical University, Ministry of Health of Russia
Russian Federation
Russian Federation
52 Krasnyy Prospekt, Novosibirsk 630091
S. V. Voloshin
Leningrad Regional Clinical Hospital
Russian Federation
Russian Federation
Build. 2A, 45 Lunacharskogo Prospekt, St. Petersburg 194291
A. D. Garifullin
Russian Research Institute of Hematology and Transfusiology, Federal Medical and Biological Agency
Russian Federation
Russian Federation
16 2nd Sovetskaya St., Saint Petersburg 191024
A. S. Chuprakova
Central City Clinical Hospital
Russian Federation
Russian Federation
3 Letnyaya St., Kaliningrad 236005
T. A. Mitina
M.F. Vladimirskiy Moscow Regional Research Clinical Institute
Russian Federation
Russian Federation
61/2 Shchepkina St., Moscow 129110
I. S. Usankin
Central City Hospital No. 7
Russian Federation
Russian Federation
33 Vilonova St., Ekaterinburg 620137
I. V. Vasileva
Central City Hospital No. 7
Russian Federation
Russian Federation
33 Vilonova St., Ekaterinburg 620137
N. V. Medvedeva
City Clinical Hospital No. 31
Russian Federation
Russian Federation
3 Prospekt Dinamo, Saint Petersburg 197110
V. V. Ryabchikova
City Clinical Hospital No. 31
Russian Federation
Russian Federation
3 Prospekt Dinamo, Saint Petersburg 197110
M. Ya. Kiseleva
N.A. Semashko Republican Clinical Hospital
Russian Federation
Russian Federation
69 Kievskaya St., Simferopol 295017
G. A. Dudina
A.S. Loginov Moscow Clinical Scientific Center, Moscow Healthcare Department
Russian Federation
Russian Federation
1 Novogireevskaya St., Moscow 111123
Yu. S. Gammershmidt
Tomsk Regional Clinical Hospital
Russian Federation
Russian Federation
96 I. Chernykh St., Tomsk 634063
O. S. Kuznetsova
A.A. Lutsik Novokuznetsk City Clinical Hospital No. 29
Russian Federation
Russian Federation
49 Sovetskoy Armii Prospekt, Novokuznetsk 654038
Yu. V. Dolgushina
A.A. Lutsik Novokuznetsk City Clinical Hospital No. 29
Russian Federation
Russian Federation
49 Sovetskoy Armii Prospekt, Novokuznetsk 654038
G. B. Kuchma
V.I. Voynov Orenburg Regional Clinical Hospital
Russian Federation
Russian Federation
23 Aksakova St., Orenburg 460018
T. N. Tsyganok
Sakhalin Regional Clinical Hospital
Russian Federation
Russian Federation
430 Mira Prospekt, Yuzhno-Sakhalinsk 693004
E. N. Misyurina
Moscow City Clinical Hospital No. 52
Russian Federation
Russian Federation
Build. 3, 3 Pekhotnaya St., Moscow 123182
E. I. Zhelnova
Moscow City Clinical Hospital No. 52
Russian Federation
Russian Federation
Build. 3, 3 Pekhotnaya St., Moscow 123182
A. V. Kopylova
Lipetsk Regional Oncological Dispensary
Russian Federation
Russian Federation
1e Admirala Makarova St., Lipetsk 398005
M. N. Zakharova
Chelyabinsk City Clinical Hospital No. 1
Russian Federation
Russian Federation
16 Vorovskogo St., Chelyabinsk 454092,
A. V. Korobkin
Chelyabinsk Regional Clinical Hospital
Russian Federation
Russian Federation
70 Vorovskogo St., Chelyabinsk 454048
G. S. Tumyan
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
Russian Federation
24 Kashirskoe Shosse, Moscow 115522
A. A. Semenova
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
Russian Federation
24 Kashirskoe Shosse, Moscow 115522
E. G. Kirillova
Regional Clinical Hospital
Russian Federation
Russian Federation
3 Berezovaya St., Omsk 644012
E. M. Volodicheva
Tula Regional Clinical Hospital
Russian Federation
Russian Federation
1a Yablochkova St., Tula 300053
V. I. Bakhtina
Regional Clinical Hospital
Russian Federation
Russian Federation
3a Partizana Zheleznyaka St., Krasnoyarsk 660022
T. I. Olkhovik
Krasnoyarsk Interdistrict Clinical Hospital No. 7
Russian Federation
Russian Federation
4 Akademika Pavlova St., Krasnoyarsk 660003
N. R. Solovkova
Irkutsk Regional Clinical Hospital
Russian Federation
Russian Federation
29 Karla Marksa St., Irkutsk 664003
M. V. Demchenkova
Irkutsk Regional Oncology Dispensary
Russian Federation
Russian Federation
32 Frunze St., Irkutsk 664035
O. E. Ochirova
N.A. Semashko Republican Clinical Hospital, Ministry of Health of the Republic of Buryatia
Russian Federation
Russian Federation
12 Pavlova St., Ulan-Ude 670047
O. L. Panteleeva
Regional Clinical Hospital
Russian Federation
Russian Federation
41 Sudogodskoye Shosse, Vladimir 600023
V. S. Abramova
Regional Clinical Hospital
Russian Federation
Russian Federation
41 Sudogodskoye Shosse, Vladimir 600023
References
1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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
13. 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
14. 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
Review
For citations:
Solovev M.V., Solovevа M.V., Mendeleeva L.P., Pospelova T.I., Skvortsova N.V., Voloshin S.V., Garifullin A.D., Chuprakova A.S., Mitina T.A., Usankin I.S., Vasileva I.V., Medvedeva N.V., Ryabchikova V.V., Kiseleva M.Ya., Dudina G.A., Gammershmidt Yu.S., Kuznetsova O.S., Dolgushina Yu.V., Kuchma G.B., Tsyganok T.N., Misyurina E.N., Zhelnova E.I., Kopylova A.V., Zakharova M.N., Korobkin A.V., Tumyan G.S., Semenova A.A., Kirillova E.G., Volodicheva E.M., Bakhtina V.I., Olkhovik T.I., Solovkova N.R., Demchenkova M.V., Ochirova O.E., Panteleeva O.L., Abramova V.S. Efficacy of IsaPomDex triplet therapy in double refractory multiple myeloma patients in real clinical practice in Russia. Oncohematology. 2024;19(4):115-123. (In Russ.) https://doi.org/10.17650/1818-8346-2024-19-4-115-123
Views:
204
Email this article 