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Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis

Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The phase III IKEMA study (clinicaltrials gov. Identifier: NCT03275285) investigated isatuximab (Isa) with carfilzomib and dexamethasone (Kd) versus Kd in relapsed MM....

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Autores principales: Capra, Marcelo, Martin, Thomas, Moreau, Philippe, Baker, Ross, Pour, Ludek, Min, Chang-Ki, Leleu, Xavier, Mohty, Mohamad, Segura, Marta Reinoso, Turgut, Mehmet, LeBlanc, Richard, Risse, Marie-Laure, Malinge, Laure, Schwab, Sandrine, Dimopoulos, Meletios
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Fondazione Ferrata Storti 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152981/
https://www.ncbi.nlm.nih.gov/pubmed/34647444
http://dx.doi.org/10.3324/haematol.2021.279229
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author Capra, Marcelo
Martin, Thomas
Moreau, Philippe
Baker, Ross
Pour, Ludek
Min, Chang-Ki
Leleu, Xavier
Mohty, Mohamad
Segura, Marta Reinoso
Turgut, Mehmet
LeBlanc, Richard
Risse, Marie-Laure
Malinge, Laure
Schwab, Sandrine
Dimopoulos, Meletios
author_facet Capra, Marcelo
Martin, Thomas
Moreau, Philippe
Baker, Ross
Pour, Ludek
Min, Chang-Ki
Leleu, Xavier
Mohty, Mohamad
Segura, Marta Reinoso
Turgut, Mehmet
LeBlanc, Richard
Risse, Marie-Laure
Malinge, Laure
Schwab, Sandrine
Dimopoulos, Meletios
author_sort Capra, Marcelo
collection PubMed
description Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The phase III IKEMA study (clinicaltrials gov. Identifier: NCT03275285) investigated isatuximab (Isa) with carfilzomib and dexamethasone (Kd) versus Kd in relapsed MM. This subgroup analysis examined results from patients with RI, defined as estimated glomerular filtration rate <60 mL/min/1.73 m². Addition of Isa prolonged progression-free survival (PFS) in patients with RI (hazard ratio: 0.27; 95% confidence interval [CI]: 0.11–0.66; median PFS not reached for Isa-Kd versus 13.4 months for Kd [20.8-month follow-up]). Complete renal responses occurred more frequently with Isa-Kd (52.0%) versus Kd (30.8%) and were durable in 32.0% versus 7.7% of patients, respectively. Treatment exposure was longer with Isa-Kd, with median number of started cycles and median duration of exposure of 20 versus 9 cycles and 81.0 versus 35.7 weeks for Isa-Kd versus Kd, respectively. Among patients with RI, the incidence of patients with grade ≥3 treatment-emergent adverse events was similar between the two arms (79.1% in Isa-Kd vs. 77.8% in Kd). In summary, the addition of Isa to Kd improved clinical outcomes with a manageable safety profile in patients with RI, consistent with the benefit observed in the overall IKEMA study population.
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spelling pubmed-91529812022-06-13 Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis Capra, Marcelo Martin, Thomas Moreau, Philippe Baker, Ross Pour, Ludek Min, Chang-Ki Leleu, Xavier Mohty, Mohamad Segura, Marta Reinoso Turgut, Mehmet LeBlanc, Richard Risse, Marie-Laure Malinge, Laure Schwab, Sandrine Dimopoulos, Meletios Haematologica Article - Plasma Cell Disorders Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The phase III IKEMA study (clinicaltrials gov. Identifier: NCT03275285) investigated isatuximab (Isa) with carfilzomib and dexamethasone (Kd) versus Kd in relapsed MM. This subgroup analysis examined results from patients with RI, defined as estimated glomerular filtration rate <60 mL/min/1.73 m². Addition of Isa prolonged progression-free survival (PFS) in patients with RI (hazard ratio: 0.27; 95% confidence interval [CI]: 0.11–0.66; median PFS not reached for Isa-Kd versus 13.4 months for Kd [20.8-month follow-up]). Complete renal responses occurred more frequently with Isa-Kd (52.0%) versus Kd (30.8%) and were durable in 32.0% versus 7.7% of patients, respectively. Treatment exposure was longer with Isa-Kd, with median number of started cycles and median duration of exposure of 20 versus 9 cycles and 81.0 versus 35.7 weeks for Isa-Kd versus Kd, respectively. Among patients with RI, the incidence of patients with grade ≥3 treatment-emergent adverse events was similar between the two arms (79.1% in Isa-Kd vs. 77.8% in Kd). In summary, the addition of Isa to Kd improved clinical outcomes with a manageable safety profile in patients with RI, consistent with the benefit observed in the overall IKEMA study population. Fondazione Ferrata Storti 2021-10-14 /pmc/articles/PMC9152981/ /pubmed/34647444 http://dx.doi.org/10.3324/haematol.2021.279229 Text en Copyright© 2022 Ferrata Storti Foundation https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Noncommercial License (by-nc 4.0) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
spellingShingle Article - Plasma Cell Disorders
Capra, Marcelo
Martin, Thomas
Moreau, Philippe
Baker, Ross
Pour, Ludek
Min, Chang-Ki
Leleu, Xavier
Mohty, Mohamad
Segura, Marta Reinoso
Turgut, Mehmet
LeBlanc, Richard
Risse, Marie-Laure
Malinge, Laure
Schwab, Sandrine
Dimopoulos, Meletios
Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis
title Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis
title_full Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis
title_fullStr Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis
title_full_unstemmed Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis
title_short Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis
title_sort isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: ikema subgroup analysis
topic Article - Plasma Cell Disorders
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152981/
https://www.ncbi.nlm.nih.gov/pubmed/34647444
http://dx.doi.org/10.3324/haematol.2021.279229
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