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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....
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Fondazione Ferrata Storti
2021
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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. |
format | Online Article Text |
id | pubmed-9152981 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Fondazione Ferrata Storti |
record_format | MEDLINE/PubMed |
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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