AustralieFrV1, PubMed, Curation, bibRecord, 000740

Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.

Identifieur interne : 000740 ( PubMed/Curation ); précédent : 000739; suivant : 000741

Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.

Auteurs : Shaji Kumar [États-Unis] ; Philippe Moreau [France] ; Parameswaran Hari [États-Unis] ; Maria-Victoria Mateos [Espagne] ; Heinz Ludwig [Autriche] ; Chaim Shustik [Canada] ; Tamas Masszi [Hongrie] ; Andrew Spencer [Australie] ; Roman Hájek [République tchèque] ; Kenneth Romeril [Nouvelle-Zélande] ; Irit Avivi [Israël] ; Anna M. Liberati [Italie] ; Monique C. Minnema [Pays-Bas] ; Hermann Einsele [Allemagne] ; Sagar Lonial [États-Unis] ; Deborah Berg [États-Unis] ; Jianchang Lin [États-Unis] ; Neeraj Gupta [États-Unis] ; Dixie-Lee Esseltine [États-Unis] ; Paul G. Richardson [États-Unis]

Source :

British journal of haematology [ 1365-2141 ] ; 2017.

RBID : pubmed:28485007

Descripteurs français

KwdFr :
- Administration par voie orale, Adulte, Adulte d'âge moyen, Calendrier d'administration des médicaments, Composés du bore (administration et posologie), Composés du bore (effets indésirables), Dexaméthasone (administration et posologie), Dexaméthasone (effets indésirables), Glycine (administration et posologie), Glycine (analogues et dérivés), Glycine (effets indésirables), Humains, Hémopathies (), Myélome multiple (traitement médicamenteux), Mâle, Méthode en double aveugle, Nausée (), Neuropathies périphériques (), Numération des leucocytes, Numération des plaquettes, Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Relation dose-effet des médicaments, Sujet âgé, Sujet âgé de 80 ans ou plus, Thalidomide (administration et posologie), Thalidomide (analogues et dérivés), Thalidomide (effets indésirables), Toxidermies (), Toxidermies (étiologie), Vomissement (), Études de suivi.
MESH :
- administration et posologie : Composés du bore, Dexaméthasone, Glycine, Thalidomide.
- analogues et dérivés : Glycine, Thalidomide.
- effets indésirables : Composés du bore, Dexaméthasone, Glycine, Protocoles de polychimiothérapie antinéoplasique, Thalidomide.
- traitement médicamenteux : Myélome multiple.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- étiologie : Toxidermies.
- Administration par voie orale, Adulte, Adulte d'âge moyen, Calendrier d'administration des médicaments, Humains, Hémopathies, Mâle, Méthode en double aveugle, Nausée, Neuropathies périphériques, Numération des leucocytes, Numération des plaquettes, Relation dose-effet des médicaments, Sujet âgé, Sujet âgé de 80 ans ou plus, Toxidermies, Vomissement, Études de suivi.

English descriptors

KwdEn :
- Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Boron Compounds (administration & dosage), Boron Compounds (adverse effects), Dexamethasone (administration & dosage), Dexamethasone (adverse effects), Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Eruptions (etiology), Drug Eruptions (therapy), Follow-Up Studies, Glycine (administration & dosage), Glycine (adverse effects), Glycine (analogs & derivatives), Hematologic Diseases (chemically induced), Hematologic Diseases (therapy), Humans, Leukocyte Count, Male, Middle Aged, Multiple Myeloma (drug therapy), Nausea (chemically induced), Nausea (therapy), Peripheral Nervous System Diseases (chemically induced), Peripheral Nervous System Diseases (therapy), Platelet Count, Thalidomide (administration & dosage), Thalidomide (adverse effects), Thalidomide (analogs & derivatives), Vomiting (chemically induced), Vomiting (therapy).
MESH :
- chemical , administration & dosage : Boron Compounds, Dexamethasone, Glycine, Thalidomide.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols, Boron Compounds, Dexamethasone, Glycine, Thalidomide.
- chemical , analogs & derivatives : Glycine, Thalidomide.
- chemically induced : Hematologic Diseases, Nausea, Peripheral Nervous System Diseases, Vomiting.
- drug therapy : Multiple Myeloma.
- etiology : Drug Eruptions.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- therapy : Drug Eruptions, Hematologic Diseases, Nausea, Peripheral Nervous System Diseases, Vomiting.
- Administration, Oral, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Follow-Up Studies, Humans, Leukocyte Count, Male, Middle Aged, Platelet Count.

Abstract

The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double-blind, placebo-controlled Phase III TOURMALINE-MM1 study of ixazomib-Rd (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma. IRd resulted in a significant improvement in progression-free survival versus placebo-Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with IRd versus placebo-Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long-term IRd treatment. Safety data from TOURMALINE-MM1 are reviewed and guidance for managing clinically relevant adverse events associated with IRd is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.

DOI: 10.1111/bjh.14733
PubMed: 28485007

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<author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name>
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<author><name sortKey="Romeril, Kenneth" sort="Romeril, Kenneth" uniqKey="Romeril K" first="Kenneth" last="Romeril">Kenneth Romeril</name>
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<author><name sortKey="Avivi, Irit" sort="Avivi, Irit" uniqKey="Avivi I" first="Irit" last="Avivi">Irit Avivi</name>
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<author><name sortKey="Liberati, Anna M" sort="Liberati, Anna M" uniqKey="Liberati A" first="Anna M" last="Liberati">Anna M. Liberati</name>
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<author><name sortKey="Minnema, Monique C" sort="Minnema, Monique C" uniqKey="Minnema M" first="Monique C" last="Minnema">Monique C. Minnema</name>
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<author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name>
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<author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name>
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<author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name>
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<author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name>
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<author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name>
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</affiliation>
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<author><name sortKey="Esseltine, Dixie Lee" sort="Esseltine, Dixie Lee" uniqKey="Esseltine D" first="Dixie-Lee" last="Esseltine">Dixie-Lee Esseltine</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA</wicri:regionArea>
</affiliation>
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<author><name sortKey="Richardson, Paul G" sort="Richardson, Paul G" uniqKey="Richardson P" first="Paul G" last="Richardson">Paul G. Richardson</name>
<affiliation wicri:level="1"><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Dana-Farber Cancer Institute, Boston, MA</wicri:regionArea>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.</title>
<author><name sortKey="Kumar, Shaji" sort="Kumar, Shaji" uniqKey="Kumar S" first="Shaji" last="Kumar">Shaji Kumar</name>
<affiliation wicri:level="1"><nlm:affiliation>Division of Hematology, Mayo Clinic, Rochester, MN, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Hematology, Mayo Clinic, Rochester, MN</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name>
<affiliation wicri:level="1"><nlm:affiliation>University Hospital Hôtel Dieu, Nantes, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>University Hospital Hôtel Dieu, Nantes</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Hari, Parameswaran" sort="Hari, Parameswaran" uniqKey="Hari P" first="Parameswaran" last="Hari">Parameswaran Hari</name>
<affiliation wicri:level="1"><nlm:affiliation>Division of Hematology and Oncology, Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, WI, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Hematology and Oncology, Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, WI</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mateos, Maria Victoria" sort="Mateos, Maria Victoria" uniqKey="Mateos M" first="Maria-Victoria" last="Mateos">Maria-Victoria Mateos</name>
<affiliation wicri:level="1"><nlm:affiliation>Servicio de Hematología, Hospital Universitario de Salamanca, Salamanca, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Servicio de Hematología, Hospital Universitario de Salamanca, Salamanca</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name>
<affiliation wicri:level="1"><nlm:affiliation>Wilhelminenspital der Stadt Wien, Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Wilhelminenspital der Stadt Wien, Vienna</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Shustik, Chaim" sort="Shustik, Chaim" uniqKey="Shustik C" first="Chaim" last="Shustik">Chaim Shustik</name>
<affiliation wicri:level="1"><nlm:affiliation>McGill University Health Center, Royal Victoria Hospital, Montreal, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>McGill University Health Center, Royal Victoria Hospital, Montreal</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Haematology and Stem Cell Transplantation, St István and St László Hospital, Semmelweis University, Budapest, Hungary.</nlm:affiliation>
<country xml:lang="fr">Hongrie</country>
<wicri:regionArea>Department of Haematology and Stem Cell Transplantation, St István and St László Hospital, Semmelweis University, Budapest</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name>
<affiliation wicri:level="1"><nlm:affiliation>Alfred Health-Monash University, Melbourne, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Alfred Health-Monash University, Melbourne</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Hajek, Roman" sort="Hajek, Roman" uniqKey="Hajek R" first="Roman" last="Hájek">Roman Hájek</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Haematooncology, University Hospital Ostrava, Ostrava, Czech Republic.</nlm:affiliation>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea>Department of Haematooncology, University Hospital Ostrava, Ostrava</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Romeril, Kenneth" sort="Romeril, Kenneth" uniqKey="Romeril K" first="Kenneth" last="Romeril">Kenneth Romeril</name>
<affiliation wicri:level="1"><nlm:affiliation>Wellington Blood and Cancer Centre, Wellington Regional Hospital, Wellington, New Zealand.</nlm:affiliation>
<country xml:lang="fr">Nouvelle-Zélande</country>
<wicri:regionArea>Wellington Blood and Cancer Centre, Wellington Regional Hospital, Wellington</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Avivi, Irit" sort="Avivi, Irit" uniqKey="Avivi I" first="Irit" last="Avivi">Irit Avivi</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Haematology and Bone Marrow Transplantation, Tel Aviv Medical Centre, Tel Aviv, Israel.</nlm:affiliation>
<country xml:lang="fr">Israël</country>
<wicri:regionArea>Department of Haematology and Bone Marrow Transplantation, Tel Aviv Medical Centre, Tel Aviv</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Liberati, Anna M" sort="Liberati, Anna M" uniqKey="Liberati A" first="Anna M" last="Liberati">Anna M. Liberati</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Perugia, SC Oncoematologia AO S. Maria di Terni, Terni, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>University of Perugia, SC Oncoematologia AO S. Maria di Terni, Terni</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Minnema, Monique C" sort="Minnema, Monique C" uniqKey="Minnema M" first="Monique C" last="Minnema">Monique C. Minnema</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, UMC Utrecht Cancer Centre, Utrecht, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Haematology, UMC Utrecht Cancer Centre, Utrecht</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name>
<affiliation wicri:level="1"><nlm:affiliation>Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik II, Würzburg</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name>
<affiliation wicri:level="1"><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name>
<affiliation wicri:level="1"><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name>
<affiliation wicri:level="1"><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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</affiliation>
</author>
<author><name sortKey="Esseltine, Dixie Lee" sort="Esseltine, Dixie Lee" uniqKey="Esseltine D" first="Dixie-Lee" last="Esseltine">Dixie-Lee Esseltine</name>
<affiliation wicri:level="1"><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Richardson, Paul G" sort="Richardson, Paul G" uniqKey="Richardson P" first="Paul G" last="Richardson">Paul G. Richardson</name>
<affiliation wicri:level="1"><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Dana-Farber Cancer Institute, Boston, MA</wicri:regionArea>
</affiliation>
</author>
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<series><title level="j">British journal of haematology</title>
<idno type="eISSN">1365-2141</idno>
<imprint><date when="2017" type="published">2017</date>
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<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Boron Compounds (administration & dosage)</term>
<term>Boron Compounds (adverse effects)</term>
<term>Dexamethasone (administration & dosage)</term>
<term>Dexamethasone (adverse effects)</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Administration Schedule</term>
<term>Drug Eruptions (etiology)</term>
<term>Drug Eruptions (therapy)</term>
<term>Follow-Up Studies</term>
<term>Glycine (administration & dosage)</term>
<term>Glycine (adverse effects)</term>
<term>Glycine (analogs & derivatives)</term>
<term>Hematologic Diseases (chemically induced)</term>
<term>Hematologic Diseases (therapy)</term>
<term>Humans</term>
<term>Leukocyte Count</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Multiple Myeloma (drug therapy)</term>
<term>Nausea (chemically induced)</term>
<term>Nausea (therapy)</term>
<term>Peripheral Nervous System Diseases (chemically induced)</term>
<term>Peripheral Nervous System Diseases (therapy)</term>
<term>Platelet Count</term>
<term>Thalidomide (administration & dosage)</term>
<term>Thalidomide (adverse effects)</term>
<term>Thalidomide (analogs & derivatives)</term>
<term>Vomiting (chemically induced)</term>
<term>Vomiting (therapy)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Administration par voie orale</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Calendrier d'administration des médicaments</term>
<term>Composés du bore (administration et posologie)</term>
<term>Composés du bore (effets indésirables)</term>
<term>Dexaméthasone (administration et posologie)</term>
<term>Dexaméthasone (effets indésirables)</term>
<term>Glycine (administration et posologie)</term>
<term>Glycine (analogues et dérivés)</term>
<term>Glycine (effets indésirables)</term>
<term>Humains</term>
<term>Hémopathies ()</term>
<term>Myélome multiple (traitement médicamenteux)</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Nausée ()</term>
<term>Neuropathies périphériques ()</term>
<term>Numération des leucocytes</term>
<term>Numération des plaquettes</term>
<term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term>
<term>Relation dose-effet des médicaments</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Thalidomide (administration et posologie)</term>
<term>Thalidomide (analogues et dérivés)</term>
<term>Thalidomide (effets indésirables)</term>
<term>Toxidermies ()</term>
<term>Toxidermies (étiologie)</term>
<term>Vomissement ()</term>
<term>Études de suivi</term>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Boron Compounds</term>
<term>Dexamethasone</term>
<term>Glycine</term>
<term>Thalidomide</term>
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<term>Dexaméthasone</term>
<term>Glycine</term>
<term>Thalidomide</term>
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<term>Boron Compounds</term>
<term>Dexamethasone</term>
<term>Glycine</term>
<term>Thalidomide</term>
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<term>Thalidomide</term>
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<term>Thalidomide</term>
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<term>Nausea</term>
<term>Peripheral Nervous System Diseases</term>
<term>Vomiting</term>
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<term>Dexaméthasone</term>
<term>Glycine</term>
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<term>Thalidomide</term>
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</keywords>
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<term>Hematologic Diseases</term>
<term>Nausea</term>
<term>Peripheral Nervous System Diseases</term>
<term>Vomiting</term>
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<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Administration Schedule</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Leukocyte Count</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Platelet Count</term>
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<term>Adulte d'âge moyen</term>
<term>Calendrier d'administration des médicaments</term>
<term>Humains</term>
<term>Hémopathies</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Nausée</term>
<term>Neuropathies périphériques</term>
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<term>Numération des plaquettes</term>
<term>Relation dose-effet des médicaments</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
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<front><div type="abstract" xml:lang="en">The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double-blind, placebo-controlled Phase III TOURMALINE-MM1 study of ixazomib-Rd (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma. IRd resulted in a significant improvement in progression-free survival versus placebo-Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with IRd versus placebo-Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long-term IRd treatment. Safety data from TOURMALINE-MM1 are reviewed and guidance for managing clinically relevant adverse events associated with IRd is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28485007</PMID>
<DateCreated><Year>2017</Year>
<Month>05</Month>
<Day>09</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>09</Month>
<Day>18</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>09</Month>
<Day>18</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1365-2141</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>178</Volume>
<Issue>4</Issue>
<PubDate><Year>2017</Year>
<Month>Aug</Month>
</PubDate>
</JournalIssue>
<Title>British journal of haematology</Title>
<ISOAbbreviation>Br. J. Haematol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.</ArticleTitle>
<Pagination><MedlinePgn>571-582</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1111/bjh.14733</ELocationID>
<Abstract><AbstractText>The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double-blind, placebo-controlled Phase III TOURMALINE-MM1 study of ixazomib-Rd (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma. IRd resulted in a significant improvement in progression-free survival versus placebo-Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with IRd versus placebo-Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long-term IRd treatment. Safety data from TOURMALINE-MM1 are reviewed and guidance for managing clinically relevant adverse events associated with IRd is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.</AbstractText>
<CopyrightInformation>© 2017 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kumar</LastName>
<ForeName>Shaji</ForeName>
<Initials>S</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0001-5392-9284</Identifier>
<AffiliationInfo><Affiliation>Division of Hematology, Mayo Clinic, Rochester, MN, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Moreau</LastName>
<ForeName>Philippe</ForeName>
<Initials>P</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0003-1780-8746</Identifier>
<AffiliationInfo><Affiliation>University Hospital Hôtel Dieu, Nantes, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hari</LastName>
<ForeName>Parameswaran</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Division of Hematology and Oncology, Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, WI, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mateos</LastName>
<ForeName>Maria-Victoria</ForeName>
<Initials>MV</Initials>
<AffiliationInfo><Affiliation>Servicio de Hematología, Hospital Universitario de Salamanca, Salamanca, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ludwig</LastName>
<ForeName>Heinz</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Wilhelminenspital der Stadt Wien, Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shustik</LastName>
<ForeName>Chaim</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>McGill University Health Center, Royal Victoria Hospital, Montreal, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Masszi</LastName>
<ForeName>Tamas</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Department of Haematology and Stem Cell Transplantation, St István and St László Hospital, Semmelweis University, Budapest, Hungary.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Spencer</LastName>
<ForeName>Andrew</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Alfred Health-Monash University, Melbourne, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hájek</LastName>
<ForeName>Roman</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Department of Haematooncology, University Hospital Ostrava, Ostrava, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Romeril</LastName>
<ForeName>Kenneth</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Wellington Blood and Cancer Centre, Wellington Regional Hospital, Wellington, New Zealand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Avivi</LastName>
<ForeName>Irit</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Department of Haematology and Bone Marrow Transplantation, Tel Aviv Medical Centre, Tel Aviv, Israel.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Liberati</LastName>
<ForeName>Anna M</ForeName>
<Initials>AM</Initials>
<AffiliationInfo><Affiliation>University of Perugia, SC Oncoematologia AO S. Maria di Terni, Terni, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Minnema</LastName>
<ForeName>Monique C</ForeName>
<Initials>MC</Initials>
<AffiliationInfo><Affiliation>Department of Haematology, UMC Utrecht Cancer Centre, Utrecht, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Einsele</LastName>
<ForeName>Hermann</ForeName>
<Initials>H</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0002-7680-0819</Identifier>
<AffiliationInfo><Affiliation>Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lonial</LastName>
<ForeName>Sagar</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Berg</LastName>
<ForeName>Deborah</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lin</LastName>
<ForeName>Jianchang</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gupta</LastName>
<ForeName>Neeraj</ForeName>
<Initials>N</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0002-5500-5218</Identifier>
<AffiliationInfo><Affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Esseltine</LastName>
<ForeName>Dixie-Lee</ForeName>
<Initials>DL</Initials>
<AffiliationInfo><Affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Richardson</LastName>
<ForeName>Paul G</ForeName>
<Initials>PG</Initials>
<AffiliationInfo><Affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2017</Year>
<Month>05</Month>
<Day>09</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Br J Haematol</MedlineTA>
<NlmUniqueID>0372544</NlmUniqueID>
<ISSNLinking>0007-1048</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D001896">Boron Compounds</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>4Z8R6ORS6L</RegistryNumber>
<NameOfSubstance UI="D013792">Thalidomide</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>71050168A2</RegistryNumber>
<NameOfSubstance UI="C548400">ixazomib</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>7S5I7G3JQL</RegistryNumber>
<NameOfSubstance UI="D003907">Dexamethasone</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>F0P408N6V4</RegistryNumber>
<NameOfSubstance UI="C467567">lenalidomide</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>TE7660XO1C</RegistryNumber>
<NameOfSubstance UI="D005998">Glycine</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
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   |texte=   Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.
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	Serveur d'exploration sur les relations entre la France et l'Australie
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Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.

Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.

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