Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.
Identifieur interne : 000743 ( PubMed/Corpus ); précédent : 000742; suivant : 000744Management 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 [ 1365-2141 ] ; 2017.
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
Links to Exploration step
pubmed:28485007Le document en format XML
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Liberati</name><affiliation><nlm:affiliation>University of Perugia, SC Oncoematologia AO S. Maria di Terni, Terni, Italy.</nlm:affiliation></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:affiliation>Department of Haematology, UMC Utrecht Cancer Centre, Utrecht, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation><nlm:affiliation>Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><affiliation><nlm:affiliation>Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><affiliation><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><affiliation><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><affiliation><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation></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><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation></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:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation></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></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><nlm:affiliation>Division of Hematology, Mayo Clinic, Rochester, MN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name><affiliation><nlm:affiliation>University Hospital Hôtel Dieu, Nantes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Hari, Parameswaran" sort="Hari, Parameswaran" uniqKey="Hari P" first="Parameswaran" last="Hari">Parameswaran Hari</name><affiliation><nlm:affiliation>Division of Hematology and Oncology, Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, WI, USA.</nlm:affiliation></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><nlm:affiliation>Servicio de Hematología, Hospital Universitario de Salamanca, Salamanca, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name><affiliation><nlm:affiliation>Wilhelminenspital der Stadt Wien, Vienna, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Shustik, Chaim" sort="Shustik, Chaim" uniqKey="Shustik C" first="Chaim" last="Shustik">Chaim Shustik</name><affiliation><nlm:affiliation>McGill University Health Center, Royal Victoria Hospital, Montreal, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name><affiliation><nlm:affiliation>Department of Haematology and Stem Cell Transplantation, St István and St László Hospital, Semmelweis University, Budapest, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation><nlm:affiliation>Alfred Health-Monash University, Melbourne, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Hajek, Roman" sort="Hajek, Roman" uniqKey="Hajek R" first="Roman" last="Hájek">Roman Hájek</name><affiliation><nlm:affiliation>Department of Haematooncology, University Hospital Ostrava, Ostrava, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Romeril, Kenneth" sort="Romeril, Kenneth" uniqKey="Romeril K" first="Kenneth" last="Romeril">Kenneth Romeril</name><affiliation><nlm:affiliation>Wellington Blood and Cancer Centre, Wellington Regional Hospital, Wellington, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Avivi, Irit" sort="Avivi, Irit" uniqKey="Avivi I" first="Irit" last="Avivi">Irit Avivi</name><affiliation><nlm:affiliation>Department of Haematology and Bone Marrow Transplantation, Tel Aviv Medical Centre, Tel Aviv, Israel.</nlm:affiliation></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:affiliation>University of Perugia, SC Oncoematologia AO S. Maria di Terni, Terni, Italy.</nlm:affiliation></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:affiliation>Department of Haematology, UMC Utrecht Cancer Centre, Utrecht, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation><nlm:affiliation>Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><affiliation><nlm:affiliation>Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><affiliation><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><affiliation><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><affiliation><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation></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><nlm:affiliation>Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.</nlm:affiliation></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:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation></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="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="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="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="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" 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></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><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 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UI="D001896" MajorTopicYN="N">Boron Compounds</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003907" MajorTopicYN="N">Dexamethasone</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003875" MajorTopicYN="N">Drug Eruptions</DescriptorName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName><QualifierName UI="Q000628" MajorTopicYN="N">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005998" MajorTopicYN="N">Glycine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000031" MajorTopicYN="N">analogs & derivatives</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006402" MajorTopicYN="N">Hematologic Diseases</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000628" MajorTopicYN="N">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007958" MajorTopicYN="N">Leukocyte 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Count</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013792" MajorTopicYN="N">Thalidomide</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000031" MajorTopicYN="N">analogs & derivatives</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014839" MajorTopicYN="N">Vomiting</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000628" MajorTopicYN="N">therapy</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">dosing</Keyword><Keyword MajorTopicYN="N">ixazomib</Keyword><Keyword MajorTopicYN="N">multiple myeloma</Keyword><Keyword MajorTopicYN="N">proteasome inhibitor</Keyword><Keyword MajorTopicYN="N">toxicity</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>12</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>03</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>5</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>9</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>5</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28485007</ArticleId><ArticleId IdType="doi">10.1111/bjh.14733</ArticleId><ArticleId IdType="pmc">PMC5574012</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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