Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma

What is this summary about? This plain language summary describes the results of a phase 1 research study (or clinical trial) called MonumenTAL-1 published in the New England Journal of Medicine in December 2022. A phase 1 study is an early clinical trial where researchers evaluate how safe a medici...

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Autores: Chari, Ajai|||0000-0002-0405-7480, Askari, Elham, Caers, Jo, Costa, Luciano J., Hilder, Brandi W., Krishnan, Amrita, Mateos, M. V.|||0000-0003-2390-1218, Minnema, Monique C., Oriol, Albert|||0000-0001-6804-2221, Pillarisetti, Kodandaram, Van De Donk, Niels W.C.J., Rodriguez-Otero, Paula|||0000-0001-5236-7785
Formato: artículo
Fecha de publicación:2023
País:España
Recursos:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:289754
Acesso em linha:https://ddd.uab.cat/record/289754
https://dx.doi.org/urn:doi:10.2217/fon-2023-0332
Access Level:acceso abierto
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dc.title.none.fl_str_mv Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma
title Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma
spellingShingle Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma
Chari, Ajai|||0000-0002-0405-7480
title_short Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma
title_full Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma
title_fullStr Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma
title_full_unstemmed Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma
title_sort Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma
dc.creator.none.fl_str_mv Chari, Ajai|||0000-0002-0405-7480
Askari, Elham
Caers, Jo
Costa, Luciano J.
Hilder, Brandi W.
Krishnan, Amrita
Mateos, M. V.|||0000-0003-2390-1218
Minnema, Monique C.
Oriol, Albert|||0000-0001-6804-2221
Pillarisetti, Kodandaram
Van De Donk, Niels W.C.J.
Rodriguez-Otero, Paula|||0000-0001-5236-7785
author Chari, Ajai|||0000-0002-0405-7480
author_facet Chari, Ajai|||0000-0002-0405-7480
Askari, Elham
Caers, Jo
Costa, Luciano J.
Hilder, Brandi W.
Krishnan, Amrita
Mateos, M. V.|||0000-0003-2390-1218
Minnema, Monique C.
Oriol, Albert|||0000-0001-6804-2221
Pillarisetti, Kodandaram
Van De Donk, Niels W.C.J.
Rodriguez-Otero, Paula|||0000-0001-5236-7785
author_role author
author2 Askari, Elham
Caers, Jo
Costa, Luciano J.
Hilder, Brandi W.
Krishnan, Amrita
Mateos, M. V.|||0000-0003-2390-1218
Minnema, Monique C.
Oriol, Albert|||0000-0001-6804-2221
Pillarisetti, Kodandaram
Van De Donk, Niels W.C.J.
Rodriguez-Otero, Paula|||0000-0001-5236-7785
author2_role author
author
author
author
author
author
author
author
author
author
author
description What is this summary about? This plain language summary describes the results of a phase 1 research study (or clinical trial) called MonumenTAL-1 published in the New England Journal of Medicine in December 2022. A phase 1 study is an early clinical trial where researchers evaluate how safe a medicine is at different doses in a small number of people. In the MonumenTAL-1 study, researchers looked at a new medicine under development called talquetamab, for people living with multiple myeloma (a type of blood cancer) who did not respond (refractory), stopped responding (relapsed), or who had difficulty dealing with their previous treatments. How was the study conducted? The phase 1 MonumenTAL-1 study was performed in 2 parts. Safety was the main focus of Part 1 in which side effects, and how serious they were, were assessed. The results of Part 1 were used to identify doses of talquetamab that were well tolerated, without a need to stop treatment or reduce the doses, for further study in Part 2. Part 2 of the study examined how well talquetamab worked to decrease signs of the cancer and what side effects, and their severity, people experienced at the doses identified in Part 1. What were the results? In Part 1 of the study, researchers identified 2 doses of talquetamab for further study: 405 micrograms for every kilogram of body weight (μg/kg) given weekly and 800 μg/kg every other week. All participants experienced at least one side effect of treatment at these 2 doses. Less than half of participants (43% at 405 μg/kg weekly dose and 34% at the 800 μg/kg every other week dose) experienced serious side effects which are those side effects that led to hospitalization, death, or permanent or life-threatening damage). The most common side effects at both doses were a condition known as cytokine release syndrome (CRS); changes in blood cell levels (where different types of cells in the blood were measured); changes in skin such as itching, dry skin, eczema, ulcers or shedding; changes in nails such as discoloration or ridging (lines or dents); and changes in sense of taste such as food tasting sour or metallic. CRS is caused by the overactivation of the immune system (the body's natural defense system) and can result in fever, feeling sick (nausea), being tired (fatigue), low blood pressure, low blood oxygen levels and body aches. Most cases of CRS, as well as most other side effects, were mild or moderate. Most common serious events were CRS, fever and bone pain. Most people had fewer signs of the cancer after taking talquetamab, and the response was similar between the 2 doses. The median duration of response at the 2 identified doses was 8-10 months. What do the results mean? Most of the side effects people experienced when taking talquetamab were mild or moderate. Most people who took talquetamab responded to the treatment even though they hadn't responded or stopped responding to previous multiple myeloma treatments or stopped taking those treatments because they were unable to tolerate them. These results demonstrate the potential of talquetamab as a treatment option in people who have used up other available therapy options. The 2 doses of talquetamab identified here are being examined in a larger group of participants to further test for safety and to test how well people respond.
publishDate 2023
dc.date.none.fl_str_mv 2
2023-01-01
2023
2023-01-01
dc.type.none.fl_str_mv Article de revisió
http://purl.org/coar/resource_type/c_dcae04bc
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/289754
https://dx.doi.org/urn:doi:10.2217/fon-2023-0332
url https://ddd.uab.cat/record/289754
https://dx.doi.org/urn:doi:10.2217/fon-2023-0332
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
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rights_invalid_str_mv open access
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dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
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spelling Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myelomaChari, Ajai|||0000-0002-0405-7480Askari, ElhamCaers, JoCosta, Luciano J.Hilder, Brandi W.Krishnan, AmritaMateos, M. V.|||0000-0003-2390-1218Minnema, Monique C.Oriol, Albert|||0000-0001-6804-2221Pillarisetti, KodandaramVan De Donk, Niels W.C.J.Rodriguez-Otero, Paula|||0000-0001-5236-7785What is this summary about? This plain language summary describes the results of a phase 1 research study (or clinical trial) called MonumenTAL-1 published in the New England Journal of Medicine in December 2022. A phase 1 study is an early clinical trial where researchers evaluate how safe a medicine is at different doses in a small number of people. In the MonumenTAL-1 study, researchers looked at a new medicine under development called talquetamab, for people living with multiple myeloma (a type of blood cancer) who did not respond (refractory), stopped responding (relapsed), or who had difficulty dealing with their previous treatments. How was the study conducted? The phase 1 MonumenTAL-1 study was performed in 2 parts. Safety was the main focus of Part 1 in which side effects, and how serious they were, were assessed. The results of Part 1 were used to identify doses of talquetamab that were well tolerated, without a need to stop treatment or reduce the doses, for further study in Part 2. Part 2 of the study examined how well talquetamab worked to decrease signs of the cancer and what side effects, and their severity, people experienced at the doses identified in Part 1. What were the results? In Part 1 of the study, researchers identified 2 doses of talquetamab for further study: 405 micrograms for every kilogram of body weight (μg/kg) given weekly and 800 μg/kg every other week. All participants experienced at least one side effect of treatment at these 2 doses. Less than half of participants (43% at 405 μg/kg weekly dose and 34% at the 800 μg/kg every other week dose) experienced serious side effects which are those side effects that led to hospitalization, death, or permanent or life-threatening damage). The most common side effects at both doses were a condition known as cytokine release syndrome (CRS); changes in blood cell levels (where different types of cells in the blood were measured); changes in skin such as itching, dry skin, eczema, ulcers or shedding; changes in nails such as discoloration or ridging (lines or dents); and changes in sense of taste such as food tasting sour or metallic. CRS is caused by the overactivation of the immune system (the body's natural defense system) and can result in fever, feeling sick (nausea), being tired (fatigue), low blood pressure, low blood oxygen levels and body aches. Most cases of CRS, as well as most other side effects, were mild or moderate. Most common serious events were CRS, fever and bone pain. Most people had fewer signs of the cancer after taking talquetamab, and the response was similar between the 2 doses. The median duration of response at the 2 identified doses was 8-10 months. What do the results mean? Most of the side effects people experienced when taking talquetamab were mild or moderate. Most people who took talquetamab responded to the treatment even though they hadn't responded or stopped responding to previous multiple myeloma treatments or stopped taking those treatments because they were unable to tolerate them. These results demonstrate the potential of talquetamab as a treatment option in people who have used up other available therapy options. The 2 doses of talquetamab identified here are being examined in a larger group of participants to further test for safety and to test how well people respond. 22023-01-0120232023-01-01Article de revisióhttp://purl.org/coar/resource_type/c_dcae04bcVoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/289754https://dx.doi.org/urn:doi:10.2217/fon-2023-0332reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2897542026-06-06T12:50:31Z
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