Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma
Identifieur interne : 004786 ( Ncbi/Merge ); précédent : 004785; suivant : 004787Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma
Auteurs : Shaji Kumar ; Philippe Moreau ; Parameswaran Hari ; Maria-Victoria Mateos ; Heinz Ludwig ; Chaim Shustik ; Tamas Masszi ; Andrew Spencer ; Roman Hájek ; Kenneth Romeril ; Irit Avivi ; Anna M. Liberati ; Monique C. Minnema ; Hermann Einsele ; Sagar Lonial ; Deborah Berg ; Jianchang Lin ; Neeraj Gupta ; Dixie-Lee Esseltine ; Paul G. RichardsonSource :
- British Journal of Haematology [ 0007-1048 ] ; 2017.
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
Url:
DOI: 10.1111/bjh.14733
PubMed: 28485007
PubMed Central: 5574012
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PMC:5574012Le document en format XML
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Liberati</name><affiliation><nlm:aff id="bjh14733-aff-0012"></nlm:aff></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><nlm:aff id="bjh14733-aff-0013"></nlm:aff></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation><nlm:aff id="bjh14733-aff-0014"></nlm:aff></affiliation></author><author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><affiliation><nlm:aff id="bjh14733-aff-0015"></nlm:aff></affiliation></author><author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Esseltine, Dixie Ee" sort="Esseltine, Dixie Ee" uniqKey="Esseltine D" first="Dixie-Lee" last="Esseltine">Dixie-Lee Esseltine</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></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><nlm:aff id="bjh14733-aff-0017"></nlm:aff></affiliation></author></analytic><series><title level="j">British Journal of Haematology</title><idno type="ISSN">0007-1048</idno><idno type="eISSN">1365-2141</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><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></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Boron Compounds</term><term>Dexamethasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Composés du bore</term><term>Dexaméthasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Boron Compounds</term><term>Dexamethasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Hematologic Diseases</term><term>Nausea</term><term>Peripheral Nervous System Diseases</term><term>Vomiting</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Multiple Myeloma</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Composés du bore</term><term>Dexaméthasone</term><term>Glycine</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Drug Eruptions</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Drug Eruptions</term><term>Hematologic Diseases</term><term>Nausea</term><term>Peripheral Nervous System Diseases</term><term>Vomiting</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Myélome multiple</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Toxidermies</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><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></keywords><keywords scheme="MESH" 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>Humains</term><term>Hémopathies</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>Relation dose-effet des médicaments</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Toxidermies</term><term>Vomissement</term><term>Études de suivi</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><p>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 <styled-content style="fixed-case">III TOURMALINE</styled-content>‐<styled-content style="fixed-case">MM</styled-content>1 study of ixazomib‐Rd (<styled-content style="fixed-case">IR</styled-content>d) versus placebo‐Rd in patients with relapsed/refractory multiple myeloma. <styled-content style="fixed-case">IR</styled-content>d 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 <styled-content style="fixed-case">IR</styled-content>d 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 <styled-content style="fixed-case">IR</styled-content>d treatment. Safety data from <styled-content style="fixed-case">TOURMALINE</styled-content>‐<styled-content style="fixed-case">MM</styled-content>1 are reviewed and guidance for managing clinically relevant adverse events associated with <styled-content style="fixed-case">IR</styled-content>d 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.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><double pmid="28485007"><pmc><TEI><teiHeader><fileDesc><titleStmt><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><nlm:aff id="bjh14733-aff-0001"></nlm:aff></affiliation></author><author><name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name><affiliation><nlm:aff id="bjh14733-aff-0002"></nlm:aff></affiliation></author><author><name sortKey="Hari, Parameswaran" sort="Hari, Parameswaran" uniqKey="Hari P" first="Parameswaran" last="Hari">Parameswaran Hari</name><affiliation><nlm:aff id="bjh14733-aff-0003"></nlm:aff></affiliation></author><author><name sortKey="Mateos, Maria Ictoria" sort="Mateos, Maria Ictoria" uniqKey="Mateos M" first="Maria-Victoria" last="Mateos">Maria-Victoria Mateos</name><affiliation><nlm:aff id="bjh14733-aff-0004"></nlm:aff></affiliation></author><author><name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name><affiliation><nlm:aff id="bjh14733-aff-0005"></nlm:aff></affiliation></author><author><name sortKey="Shustik, Chaim" sort="Shustik, Chaim" uniqKey="Shustik C" first="Chaim" last="Shustik">Chaim Shustik</name><affiliation><nlm:aff id="bjh14733-aff-0006"></nlm:aff></affiliation></author><author><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name><affiliation><nlm:aff id="bjh14733-aff-0007"></nlm:aff></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation><nlm:aff id="bjh14733-aff-0008"></nlm:aff></affiliation></author><author><name sortKey="Hajek, Roman" sort="Hajek, Roman" uniqKey="Hajek R" first="Roman" last="Hájek">Roman Hájek</name><affiliation><nlm:aff id="bjh14733-aff-0009"></nlm:aff></affiliation></author><author><name sortKey="Romeril, Kenneth" sort="Romeril, Kenneth" uniqKey="Romeril K" first="Kenneth" last="Romeril">Kenneth Romeril</name><affiliation><nlm:aff id="bjh14733-aff-0010"></nlm:aff></affiliation></author><author><name sortKey="Avivi, Irit" sort="Avivi, Irit" uniqKey="Avivi I" first="Irit" last="Avivi">Irit Avivi</name><affiliation><nlm:aff id="bjh14733-aff-0011"></nlm:aff></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><nlm:aff id="bjh14733-aff-0012"></nlm:aff></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><nlm:aff id="bjh14733-aff-0013"></nlm:aff></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation><nlm:aff id="bjh14733-aff-0014"></nlm:aff></affiliation></author><author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><affiliation><nlm:aff id="bjh14733-aff-0015"></nlm:aff></affiliation></author><author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Esseltine, Dixie Ee" sort="Esseltine, Dixie Ee" uniqKey="Esseltine D" first="Dixie-Lee" last="Esseltine">Dixie-Lee Esseltine</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></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><nlm:aff id="bjh14733-aff-0017"></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">28485007</idno><idno type="pmc">5574012</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5574012</idno><idno type="RBID">PMC:5574012</idno><idno type="doi">10.1111/bjh.14733</idno><date when="2017">2017</date><idno type="wicri:Area/Pmc/Corpus">002341</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002341</idno><idno type="wicri:Area/Pmc/Curation">002191</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002191</idno><idno type="wicri:Area/Pmc/Checkpoint">000207</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000207</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">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><nlm:aff id="bjh14733-aff-0001"></nlm:aff></affiliation></author><author><name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name><affiliation><nlm:aff id="bjh14733-aff-0002"></nlm:aff></affiliation></author><author><name sortKey="Hari, Parameswaran" sort="Hari, Parameswaran" uniqKey="Hari P" first="Parameswaran" last="Hari">Parameswaran Hari</name><affiliation><nlm:aff id="bjh14733-aff-0003"></nlm:aff></affiliation></author><author><name sortKey="Mateos, Maria Ictoria" sort="Mateos, Maria Ictoria" uniqKey="Mateos M" first="Maria-Victoria" last="Mateos">Maria-Victoria Mateos</name><affiliation><nlm:aff id="bjh14733-aff-0004"></nlm:aff></affiliation></author><author><name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name><affiliation><nlm:aff id="bjh14733-aff-0005"></nlm:aff></affiliation></author><author><name sortKey="Shustik, Chaim" sort="Shustik, Chaim" uniqKey="Shustik C" first="Chaim" last="Shustik">Chaim Shustik</name><affiliation><nlm:aff id="bjh14733-aff-0006"></nlm:aff></affiliation></author><author><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name><affiliation><nlm:aff id="bjh14733-aff-0007"></nlm:aff></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation><nlm:aff id="bjh14733-aff-0008"></nlm:aff></affiliation></author><author><name sortKey="Hajek, Roman" sort="Hajek, Roman" uniqKey="Hajek R" first="Roman" last="Hájek">Roman Hájek</name><affiliation><nlm:aff id="bjh14733-aff-0009"></nlm:aff></affiliation></author><author><name sortKey="Romeril, Kenneth" sort="Romeril, Kenneth" uniqKey="Romeril K" first="Kenneth" last="Romeril">Kenneth Romeril</name><affiliation><nlm:aff id="bjh14733-aff-0010"></nlm:aff></affiliation></author><author><name sortKey="Avivi, Irit" sort="Avivi, Irit" uniqKey="Avivi I" first="Irit" last="Avivi">Irit Avivi</name><affiliation><nlm:aff id="bjh14733-aff-0011"></nlm:aff></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><nlm:aff id="bjh14733-aff-0012"></nlm:aff></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><nlm:aff id="bjh14733-aff-0013"></nlm:aff></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation><nlm:aff id="bjh14733-aff-0014"></nlm:aff></affiliation></author><author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><affiliation><nlm:aff id="bjh14733-aff-0015"></nlm:aff></affiliation></author><author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Esseltine, Dixie Ee" sort="Esseltine, Dixie Ee" uniqKey="Esseltine D" first="Dixie-Lee" last="Esseltine">Dixie-Lee Esseltine</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></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><nlm:aff id="bjh14733-aff-0017"></nlm:aff></affiliation></author></analytic><series><title level="j">British Journal of Haematology</title><idno type="ISSN">0007-1048</idno><idno type="eISSN">1365-2141</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><p>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 <styled-content style="fixed-case">III TOURMALINE</styled-content>‐<styled-content style="fixed-case">MM</styled-content>1 study of ixazomib‐Rd (<styled-content style="fixed-case">IR</styled-content>d) versus placebo‐Rd in patients with relapsed/refractory multiple myeloma. <styled-content style="fixed-case">IR</styled-content>d 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 <styled-content style="fixed-case">IR</styled-content>d 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 <styled-content style="fixed-case">IR</styled-content>d treatment. Safety data from <styled-content style="fixed-case">TOURMALINE</styled-content>‐<styled-content style="fixed-case">MM</styled-content>1 are reviewed and guidance for managing clinically relevant adverse events associated with <styled-content style="fixed-case">IR</styled-content>d 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.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI></pmc><pubmed><TEI><teiHeader><fileDesc><titleStmt><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="2"><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><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name><affiliation wicri:level="3"><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><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Hari, Parameswaran" sort="Hari, Parameswaran" uniqKey="Hari P" first="Parameswaran" last="Hari">Parameswaran Hari</name><affiliation wicri:level="2"><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><placeName><region type="state">Wisconsin</region></placeName></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><wicri:noRegion>Salamanca</wicri:noRegion></affiliation></author><author><name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Shustik, Chaim" sort="Shustik, Chaim" uniqKey="Shustik C" first="Chaim" last="Shustik">Chaim Shustik</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Budapest</settlement><region nuts="2">Hongrie centrale</region></placeName></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></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><wicri:noRegion>Ostrava</wicri:noRegion></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><wicri:noRegion>Wellington</wicri:noRegion></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><wicri:noRegion>Tel Aviv</wicri:noRegion></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><wicri:noRegion>Terni</wicri:noRegion></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="3"><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><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation wicri:level="3"><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><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><affiliation wicri:level="2"><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><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><affiliation wicri:level="2"><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><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><affiliation wicri:level="2"><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><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><affiliation wicri:level="2"><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><placeName><region type="state">Massachusetts</region></placeName></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="2"><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><placeName><region type="state">Massachusetts</region></placeName></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="2"><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><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28485007</idno><idno type="pmid">28485007</idno><idno type="doi">10.1111/bjh.14733</idno><idno type="wicri:Area/PubMed/Corpus">000743</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000743</idno><idno type="wicri:Area/PubMed/Curation">000740</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000740</idno><idno type="wicri:Area/PubMed/Checkpoint">000740</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000740</idno></publicationStmt><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="2"><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><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name><affiliation wicri:level="3"><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><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Hari, Parameswaran" sort="Hari, Parameswaran" uniqKey="Hari P" first="Parameswaran" last="Hari">Parameswaran Hari</name><affiliation wicri:level="2"><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><placeName><region type="state">Wisconsin</region></placeName></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><wicri:noRegion>Salamanca</wicri:noRegion></affiliation></author><author><name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Shustik, Chaim" sort="Shustik, Chaim" uniqKey="Shustik C" first="Chaim" last="Shustik">Chaim Shustik</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Budapest</settlement><region nuts="2">Hongrie centrale</region></placeName></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></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><wicri:noRegion>Ostrava</wicri:noRegion></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><wicri:noRegion>Wellington</wicri:noRegion></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><wicri:noRegion>Tel Aviv</wicri:noRegion></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><wicri:noRegion>Terni</wicri:noRegion></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="3"><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><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation wicri:level="3"><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><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><affiliation wicri:level="2"><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><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><affiliation wicri:level="2"><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><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><affiliation wicri:level="2"><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><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><affiliation wicri:level="2"><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><placeName><region type="state">Massachusetts</region></placeName></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="2"><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><placeName><region type="state">Massachusetts</region></placeName></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="2"><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><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></analytic><series><title level="j">British journal of haematology</title><idno type="eISSN">1365-2141</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><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></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Boron Compounds</term><term>Dexamethasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Composés du bore</term><term>Dexaméthasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Boron Compounds</term><term>Dexamethasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Hematologic Diseases</term><term>Nausea</term><term>Peripheral Nervous System Diseases</term><term>Vomiting</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Multiple Myeloma</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Composés du bore</term><term>Dexaméthasone</term><term>Glycine</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Drug Eruptions</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Drug Eruptions</term><term>Hematologic Diseases</term><term>Nausea</term><term>Peripheral Nervous System Diseases</term><term>Vomiting</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Myélome multiple</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Toxidermies</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><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></keywords><keywords scheme="MESH" 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>Humains</term><term>Hémopathies</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>Relation dose-effet des médicaments</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Toxidermies</term><term>Vomissement</term><term>Études de suivi</term></keywords></textClass></profileDesc></teiHeader><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></double></record>Pour manipuler ce document sous Unix (Dilib)
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