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. 2024 Sep;113(3):290-297.
doi: 10.1111/ejh.14225. Epub 2024 May 7.

Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world: The retrospective IMAGE study

Olivier Decaux  1   2 , Jean Fontan  3 , Aurore Perrot  4 , Lionel Karlin  5 , Cyrille Touzeau  6 , Samantha Schulmann  7 , Salomon Manier  8 , Karim Belhadj  9 , Adrien Trebouet  10 , Patricia Zunic  11 , Jean-Marc Schiano De Colella  12 , Brice Castel  13 , Zoé Van De Wyngaert  14 , Gian Matteo Pica  15 , Mourad Tiab  16 , Frédérique Kuhnowski  17 , Malek Bouketouche  18 , Sophia Rigaudeau  19 , Riad Benramdane  20 , Christina Tekle  21 , Radhia Lafore  22 , Marianne Gaucher  22 , Jill Corre  23 , Xavier Leleu  24
Affiliations

Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world: The retrospective IMAGE study

Olivier Decaux et al. Eur J Haematol. 2024 Sep.

Abstract

Background: IMAGE is a retrospective cohort study of patients enrolled in early access programs (EAPs) in France with relapsed/refractory multiple myeloma (RRMM) receiving isatuximab with pomalidomide and dexamethasone (Isa-Pd).

Methods: Patients aged ≥18 years with RRMM who received ≥1 dose of Isa under the EAPs between July 29, 2019 and August 30, 2020 were included. Effectiveness endpoints included progression-free survival (PFS) and response rates. Verbatim terms for adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities and not graded for severity.

Results: A total of 294 and 299 patients were included in the effectiveness and safety populations, respectively. IMAGE included patients who received one prior line of treatment (10.2%) and were daratumumab-refractory (19.1%). At median follow-up of 14.2 months, median PFS in the effectiveness population was 12.4 months (95% CI 9.0-15.0). Overall response and very good partial response rates were 46.3% and 27.9%, respectively. Subgroup analyses reflected similar results. In the safety population, 26.4% of patients reported at least one AE; the most common any-grade AE was neutropenia (9.4%).

Conclusion: IMAGE demonstrated Isa-Pd had meaningful effectiveness in median PFS and depth of response and no new safety signals in a real-world context, consistent with clinical trial results.

Keywords: dexamethasone; isatuximab; multiple myeloma; pomalidomide; real‐world.

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References

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