AustralieFrV1, PubMed, Curation, bibRecord, 003590

Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma.

Identifieur interne : 003590 ( PubMed/Curation ); précédent : 003589; suivant : 003591

Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma.

Auteurs : Jesús San-Miguel [Espagne] ; Joan Bladé [Espagne] ; Ofer Shpilberg [Israël] ; Sebastian Grosicki [Pologne] ; Frédéric Maloisel [France] ; Chang-Ki Min [Corée du Sud] ; Marta Polo Zarzuela [Espagne] ; Tadeusz Robak [Pologne] ; Sripada V S S. Prasad [Inde] ; Yeow Tee Goh [Singapour] ; Jacob Laubach [États-Unis] ; Andrew Spencer [Australie] ; María-Victoria Mateos [Espagne] ; Antonio Palumbo [Italie] ; Tom Puchalski [États-Unis] ; Manjula Reddy [États-Unis] ; Clarissa Uhlar [États-Unis] ; Xiang Qin [États-Unis] ; Helgi Van De Velde ; Hong Xie [États-Unis] ; Robert Z. Orlowski [États-Unis]

Source :

Blood [ 1528-0020 ] ; 2014.

RBID : pubmed:24833354

Descripteurs français

KwdFr :
- Acides boroniques (administration et posologie), Adulte d'âge moyen, Anticorps monoclonaux (administration et posologie), Bortézomib, Chromosomes humains de la paire 17, Délétion de segment de chromosome, Femelle, Humains, Immunoglobuline A (sang), Interleukine-6 (antagonistes et inhibiteurs), Melphalan (administration et posologie), Myélome multiple (génétique), Myélome multiple (mortalité), Myélome multiple (sang), Myélome multiple (traitement médicamenteux), Mâle, Prednisone (administration et posologie), Protocoles de polychimiothérapie antinéoplasique (administration et posologie), Pyrazines (administration et posologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Taux de survie, Études de suivi.
MESH :
- administration et posologie : Acides boroniques, Anticorps monoclonaux, Melphalan, Prednisone, Protocoles de polychimiothérapie antinéoplasique, Pyrazines.
- antagonistes et inhibiteurs : Interleukine-6.
- génétique : Myélome multiple.
- mortalité : Myélome multiple.
- sang : Immunoglobuline A, Myélome multiple.
- traitement médicamenteux : Myélome multiple.
- Adulte d'âge moyen, Bortézomib, Chromosomes humains de la paire 17, Délétion de segment de chromosome, Femelle, Humains, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Taux de survie, Études de suivi.

English descriptors

KwdEn :
- Aged, Aged, 80 and over, Antibodies, Monoclonal (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (administration & dosage), Boronic Acids (administration & dosage), Bortezomib, Chromosome Deletion, Chromosomes, Human, Pair 17, Disease-Free Survival, Female, Follow-Up Studies, Humans, Immunoglobulin A (blood), Interleukin-6 (antagonists & inhibitors), Male, Melphalan (administration & dosage), Middle Aged, Multiple Myeloma (blood), Multiple Myeloma (drug therapy), Multiple Myeloma (genetics), Multiple Myeloma (mortality), Prednisone (administration & dosage), Pyrazines (administration & dosage), Survival Rate.
MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Boronic Acids, Melphalan, Prednisone, Pyrazines.
- administration & dosage : Antineoplastic Combined Chemotherapy Protocols.
- chemical , antagonists & inhibitors : Interleukin-6.
- chemical , blood : Immunoglobulin A, Multiple Myeloma.
- drug therapy : Multiple Myeloma.
- genetics : Multiple Myeloma.
- mortality : Multiple Myeloma.
- Aged, Aged, 80 and over, Bortezomib, Chromosome Deletion, Chromosomes, Human, Pair 17, Disease-Free Survival, Female, Follow-Up Studies, Humans, Male, Middle Aged, Survival Rate.

Abstract

Because interleukin-6 (IL-6) is considered important in the proliferation of early multiple myeloma (MM), we hypothesized that the addition of the anti-IL-6 monoclonal antibody siltuximab to the bortezomib-melphalan-prednisone (VMP) regimen would improve outcomes in transplant-ineligible patients with newly diagnosed MM. One hundred and six patients were randomized to receive 9 cycles of VMP or VMP plus siltuximab (11 mg/kg every 3 weeks) followed by siltuximab maintenance. Baseline characteristics were well balanced except for immunoglobulin A subtype and 17p deletions. With a complete response (CR) rate of 27% on siltuximab plus VMP (S+VMP) and 22% on VMP, the study did not confirm its hypothesis that the addition of siltuximab would increase the CR rate by at least 10%. Overall response rate was 88% on S+VMP and 80% on VMP, and at least very good partial response rates were 71% and 51% (P = .0382), respectively. Median progression-free survival (17 months) and 1-year overall survival (88%) were identical in the 2 arms. Grade ≥3 adverse-event incidence was 92% on S+VMP and 81% on VMP (P = .09), with trends toward more hematologic events and infections on S+VMP. Maintenance therapy with siltuximab was well tolerated. In conclusion, the addition of siltuximab to VMP did not improve the CR rate or long-term outcomes. This study was registered at http://clinicaltrials.gov as #NCT00911859.

DOI: 10.1182/blood-2013-12-546374
PubMed: 24833354

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Helgi Van De Velde

<affiliation><nlm:affiliation>Janssen Research & Development, Beerse, Belgium; and.</nlm:affiliation>
<wicri:noCountry code="subField">Belgium; and</wicri:noCountry>
</affiliation>

Le document en format XML

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<author><name sortKey="Min, Chang Ki" sort="Min, Chang Ki" uniqKey="Min C" first="Chang-Ki" last="Min">Chang-Ki Min</name>
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<author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
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<author><name sortKey="Prasad, Sripada V S S" sort="Prasad, Sripada V S S" uniqKey="Prasad S" first="Sripada V S S" last="Prasad">Sripada V S S. Prasad</name>
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<country xml:lang="fr">Inde</country>
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<author><name sortKey="Tee Goh, Yeow" sort="Tee Goh, Yeow" uniqKey="Tee Goh Y" first="Yeow" last="Tee Goh">Yeow Tee Goh</name>
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<author><name sortKey="Laubach, Jacob" sort="Laubach, Jacob" uniqKey="Laubach J" first="Jacob" last="Laubach">Jacob Laubach</name>
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<author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name>
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<author><name sortKey="Mateos, Maria Victoria" sort="Mateos, Maria Victoria" uniqKey="Mateos M" first="María-Victoria" last="Mateos">María-Victoria Mateos</name>
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<author><name sortKey="Palumbo, Antonio" sort="Palumbo, Antonio" uniqKey="Palumbo A" first="Antonio" last="Palumbo">Antonio Palumbo</name>
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<author><name sortKey="Puchalski, Tom" sort="Puchalski, Tom" uniqKey="Puchalski T" first="Tom" last="Puchalski">Tom Puchalski</name>
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<country xml:lang="fr">États-Unis</country>
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</placeName>
<wicri:cityArea>Janssen Research & Development, Spring House</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Reddy, Manjula" sort="Reddy, Manjula" uniqKey="Reddy M" first="Manjula" last="Reddy">Manjula Reddy</name>
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<author><name sortKey="Uhlar, Clarissa" sort="Uhlar, Clarissa" uniqKey="Uhlar C" first="Clarissa" last="Uhlar">Clarissa Uhlar</name>
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<author><name sortKey="Qin, Xiang" sort="Qin, Xiang" uniqKey="Qin X" first="Xiang" last="Qin">Xiang Qin</name>
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<author><name sortKey="Van De Velde, Helgi" sort="Van De Velde, Helgi" uniqKey="Van De Velde H" first="Helgi" last="Van De Velde">Helgi Van De Velde</name>
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<wicri:noCountry code="subField">Belgium; and</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Xie, Hong" sort="Xie, Hong" uniqKey="Xie H" first="Hong" last="Xie">Hong Xie</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Janssen Research & Development, Spring House</wicri:cityArea>
</affiliation>
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<author><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z" last="Orlowski">Robert Z. Orlowski</name>
<affiliation wicri:level="2"><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<wicri:cityArea>The University of Texas MD Anderson Cancer Center, Houston</wicri:cityArea>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma.</title>
<author><name sortKey="San Miguel, Jesus" sort="San Miguel, Jesus" uniqKey="San Miguel J" first="Jesús" last="San-Miguel">Jesús San-Miguel</name>
<affiliation wicri:level="1"><nlm:affiliation>Centro de Investigación Medica Aplicada, Clinica Universidad de Navarra, Navarra, Spain;</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Centro de Investigación Medica Aplicada, Clinica Universidad de Navarra, Navarra</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Blade, Joan" sort="Blade, Joan" uniqKey="Blade J" first="Joan" last="Bladé">Joan Bladé</name>
<affiliation wicri:level="1"><nlm:affiliation>Institut d'Investigacions Biomediques August Pi I Sunyer, Hospital Clinic I Provincial, Barcelona, Spain;</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Institut d'Investigacions Biomediques August Pi I Sunyer, Hospital Clinic I Provincial, Barcelona</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Shpilberg, Ofer" sort="Shpilberg, Ofer" uniqKey="Shpilberg O" first="Ofer" last="Shpilberg">Ofer Shpilberg</name>
<affiliation wicri:level="1"><nlm:affiliation>Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel;</nlm:affiliation>
<country xml:lang="fr">Israël</country>
<wicri:regionArea>Sackler School of Medicine, Tel-Aviv University, Tel-Aviv</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Grosicki, Sebastian" sort="Grosicki, Sebastian" uniqKey="Grosicki S" first="Sebastian" last="Grosicki">Sebastian Grosicki</name>
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<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Oddzial Hematologiczny SPZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Maloisel, Frederic" sort="Maloisel, Frederic" uniqKey="Maloisel F" first="Frédéric" last="Maloisel">Frédéric Maloisel</name>
<affiliation wicri:level="1"><nlm:affiliation>Clinique Saint Anne, Strasbourg, France;</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Clinique Saint Anne, Strasbourg</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Min, Chang Ki" sort="Min, Chang Ki" uniqKey="Min C" first="Chang-Ki" last="Min">Chang-Ki Min</name>
<affiliation wicri:level="1"><nlm:affiliation>Seoul St. Mary's Hospital, Seoul, Republic of Korea;</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Seoul St. Mary's Hospital, Seoul</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Polo Zarzuela, Marta" sort="Polo Zarzuela, Marta" uniqKey="Polo Zarzuela M" first="Marta" last="Polo Zarzuela">Marta Polo Zarzuela</name>
<affiliation wicri:level="1"><nlm:affiliation>Hospital Clinico San Carlos, Madrid, Spain;</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Clinico San Carlos, Madrid</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
<affiliation wicri:level="1"><nlm:affiliation>Medical University of Lodz, Lodz, Poland;</nlm:affiliation>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Medical University of Lodz, Lodz</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Prasad, Sripada V S S" sort="Prasad, Sripada V S S" uniqKey="Prasad S" first="Sripada V S S" last="Prasad">Sripada V S S. Prasad</name>
<affiliation wicri:level="1"><nlm:affiliation>Apollo Hospitals & Research Foundation, Hyderabad, India;</nlm:affiliation>
<country xml:lang="fr">Inde</country>
<wicri:regionArea>Apollo Hospitals & Research Foundation, Hyderabad</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Tee Goh, Yeow" sort="Tee Goh, Yeow" uniqKey="Tee Goh Y" first="Yeow" last="Tee Goh">Yeow Tee Goh</name>
<affiliation wicri:level="1"><nlm:affiliation>Singapore General Hospital, Singapore, Singapore;</nlm:affiliation>
<country xml:lang="fr">Singapour</country>
<wicri:regionArea>Singapore General Hospital, Singapore</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Laubach, Jacob" sort="Laubach, Jacob" uniqKey="Laubach J" first="Jacob" last="Laubach">Jacob Laubach</name>
<affiliation wicri:level="2"><nlm:affiliation>Dana Farber Cancer Institute, Boston, MA;</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Dana Farber Cancer Institute, Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name>
<affiliation wicri:level="1"><nlm:affiliation>Alfred Health-Monash University, Melbourne, Australia;</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Alfred Health-Monash University, Melbourne</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mateos, Maria Victoria" sort="Mateos, Maria Victoria" uniqKey="Mateos M" first="María-Victoria" last="Mateos">María-Victoria Mateos</name>
<affiliation wicri:level="1"><nlm:affiliation>Hospital Universitario Salamanca, Salamanca, Spain;</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitario Salamanca, Salamanca</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Palumbo, Antonio" sort="Palumbo, Antonio" uniqKey="Palumbo A" first="Antonio" last="Palumbo">Antonio Palumbo</name>
<affiliation wicri:level="1"><nlm:affiliation>Ospedale Le Molinette, Torino, Italy;</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Ospedale Le Molinette, Torino</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Puchalski, Tom" sort="Puchalski, Tom" uniqKey="Puchalski T" first="Tom" last="Puchalski">Tom Puchalski</name>
<affiliation wicri:level="2"><nlm:affiliation>Janssen Research & Development, Spring House, PA;</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Janssen Research & Development, Spring House</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Reddy, Manjula" sort="Reddy, Manjula" uniqKey="Reddy M" first="Manjula" last="Reddy">Manjula Reddy</name>
<affiliation wicri:level="2"><nlm:affiliation>Janssen Research & Development, Spring House, PA;</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Janssen Research & Development, Spring House</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Uhlar, Clarissa" sort="Uhlar, Clarissa" uniqKey="Uhlar C" first="Clarissa" last="Uhlar">Clarissa Uhlar</name>
<affiliation wicri:level="2"><nlm:affiliation>Janssen Research & Development, Spring House, PA;</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Janssen Research & Development, Spring House</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Qin, Xiang" sort="Qin, Xiang" uniqKey="Qin X" first="Xiang" last="Qin">Xiang Qin</name>
<affiliation wicri:level="2"><nlm:affiliation>Janssen Research & Development, Spring House, PA;</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Janssen Research & Development, Spring House</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Van De Velde, Helgi" sort="Van De Velde, Helgi" uniqKey="Van De Velde H" first="Helgi" last="Van De Velde">Helgi Van De Velde</name>
<affiliation><nlm:affiliation>Janssen Research & Development, Beerse, Belgium; and.</nlm:affiliation>
<wicri:noCountry code="subField">Belgium; and</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Xie, Hong" sort="Xie, Hong" uniqKey="Xie H" first="Hong" last="Xie">Hong Xie</name>
<affiliation wicri:level="2"><nlm:affiliation>Janssen Research & Development, Spring House, PA;</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Janssen Research & Development, Spring House</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z" last="Orlowski">Robert Z. Orlowski</name>
<affiliation wicri:level="2"><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<wicri:cityArea>The University of Texas MD Anderson Cancer Center, Houston</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Blood</title>
<idno type="eISSN">1528-0020</idno>
<imprint><date when="2014" type="published">2014</date>
</imprint>
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<term>Aged, 80 and over</term>
<term>Antibodies, Monoclonal (administration & dosage)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (administration & dosage)</term>
<term>Boronic Acids (administration & dosage)</term>
<term>Bortezomib</term>
<term>Chromosome Deletion</term>
<term>Chromosomes, Human, Pair 17</term>
<term>Disease-Free Survival</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Immunoglobulin A (blood)</term>
<term>Interleukin-6 (antagonists & inhibitors)</term>
<term>Male</term>
<term>Melphalan (administration & dosage)</term>
<term>Middle Aged</term>
<term>Multiple Myeloma (blood)</term>
<term>Multiple Myeloma (drug therapy)</term>
<term>Multiple Myeloma (genetics)</term>
<term>Multiple Myeloma (mortality)</term>
<term>Prednisone (administration & dosage)</term>
<term>Pyrazines (administration & dosage)</term>
<term>Survival Rate</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Acides boroniques (administration et posologie)</term>
<term>Adulte d'âge moyen</term>
<term>Anticorps monoclonaux (administration et posologie)</term>
<term>Bortézomib</term>
<term>Chromosomes humains de la paire 17</term>
<term>Délétion de segment de chromosome</term>
<term>Femelle</term>
<term>Humains</term>
<term>Immunoglobuline A (sang)</term>
<term>Interleukine-6 (antagonistes et inhibiteurs)</term>
<term>Melphalan (administration et posologie)</term>
<term>Myélome multiple (génétique)</term>
<term>Myélome multiple (mortalité)</term>
<term>Myélome multiple (sang)</term>
<term>Myélome multiple (traitement médicamenteux)</term>
<term>Mâle</term>
<term>Prednisone (administration et posologie)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (administration et posologie)</term>
<term>Pyrazines (administration et posologie)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Survie sans rechute</term>
<term>Taux de survie</term>
<term>Études de suivi</term>
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<term>Boronic Acids</term>
<term>Melphalan</term>
<term>Prednisone</term>
<term>Pyrazines</term>
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</keywords>
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<term>Anticorps monoclonaux</term>
<term>Melphalan</term>
<term>Prednisone</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
<term>Pyrazines</term>
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</keywords>
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<term>Multiple Myeloma</term>
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</keywords>
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<term>Myélome multiple</term>
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<term>Aged, 80 and over</term>
<term>Bortezomib</term>
<term>Chromosome Deletion</term>
<term>Chromosomes, Human, Pair 17</term>
<term>Disease-Free Survival</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Survival Rate</term>
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<term>Bortézomib</term>
<term>Chromosomes humains de la paire 17</term>
<term>Délétion de segment de chromosome</term>
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<term>Humains</term>
<term>Mâle</term>
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<front><div type="abstract" xml:lang="en">Because interleukin-6 (IL-6) is considered important in the proliferation of early multiple myeloma (MM), we hypothesized that the addition of the anti-IL-6 monoclonal antibody siltuximab to the bortezomib-melphalan-prednisone (VMP) regimen would improve outcomes in transplant-ineligible patients with newly diagnosed MM. One hundred and six patients were randomized to receive 9 cycles of VMP or VMP plus siltuximab (11 mg/kg every 3 weeks) followed by siltuximab maintenance. Baseline characteristics were well balanced except for immunoglobulin A subtype and 17p deletions. With a complete response (CR) rate of 27% on siltuximab plus VMP (S+VMP) and 22% on VMP, the study did not confirm its hypothesis that the addition of siltuximab would increase the CR rate by at least 10%. Overall response rate was 88% on S+VMP and 80% on VMP, and at least very good partial response rates were 71% and 51% (P = .0382), respectively. Median progression-free survival (17 months) and 1-year overall survival (88%) were identical in the 2 arms. Grade ≥3 adverse-event incidence was 92% on S+VMP and 81% on VMP (P = .09), with trends toward more hematologic events and infections on S+VMP. Maintenance therapy with siltuximab was well tolerated. In conclusion, the addition of siltuximab to VMP did not improve the CR rate or long-term outcomes. This study was registered at http://clinicaltrials.gov as #NCT00911859.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24833354</PMID>
<DateCreated><Year>2014</Year>
<Month>06</Month>
<Day>27</Day>
</DateCreated>
<DateCompleted><Year>2014</Year>
<Month>09</Month>
<Day>04</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>11</Month>
<Day>16</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1528-0020</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>123</Volume>
<Issue>26</Issue>
<PubDate><Year>2014</Year>
<Month>Jun</Month>
<Day>26</Day>
</PubDate>
</JournalIssue>
<Title>Blood</Title>
<ISOAbbreviation>Blood</ISOAbbreviation>
</Journal>
<ArticleTitle>Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma.</ArticleTitle>
<Pagination><MedlinePgn>4136-42</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1182/blood-2013-12-546374</ELocationID>
<Abstract><AbstractText>Because interleukin-6 (IL-6) is considered important in the proliferation of early multiple myeloma (MM), we hypothesized that the addition of the anti-IL-6 monoclonal antibody siltuximab to the bortezomib-melphalan-prednisone (VMP) regimen would improve outcomes in transplant-ineligible patients with newly diagnosed MM. One hundred and six patients were randomized to receive 9 cycles of VMP or VMP plus siltuximab (11 mg/kg every 3 weeks) followed by siltuximab maintenance. Baseline characteristics were well balanced except for immunoglobulin A subtype and 17p deletions. With a complete response (CR) rate of 27% on siltuximab plus VMP (S+VMP) and 22% on VMP, the study did not confirm its hypothesis that the addition of siltuximab would increase the CR rate by at least 10%. Overall response rate was 88% on S+VMP and 80% on VMP, and at least very good partial response rates were 71% and 51% (P = .0382), respectively. Median progression-free survival (17 months) and 1-year overall survival (88%) were identical in the 2 arms. Grade ≥3 adverse-event incidence was 92% on S+VMP and 81% on VMP (P = .09), with trends toward more hematologic events and infections on S+VMP. Maintenance therapy with siltuximab was well tolerated. In conclusion, the addition of siltuximab to VMP did not improve the CR rate or long-term outcomes. This study was registered at http://clinicaltrials.gov as #NCT00911859.</AbstractText>
<CopyrightInformation>© 2014 by The American Society of Hematology.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>San-Miguel</LastName>
<ForeName>Jesús</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Centro de Investigación Medica Aplicada, Clinica Universidad de Navarra, Navarra, Spain;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bladé</LastName>
<ForeName>Joan</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Institut d'Investigacions Biomediques August Pi I Sunyer, Hospital Clinic I Provincial, Barcelona, Spain;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shpilberg</LastName>
<ForeName>Ofer</ForeName>
<Initials>O</Initials>
<AffiliationInfo><Affiliation>Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Grosicki</LastName>
<ForeName>Sebastian</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Oddzial Hematologiczny SPZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow, Poland;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Maloisel</LastName>
<ForeName>Frédéric</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Clinique Saint Anne, Strasbourg, France;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Min</LastName>
<ForeName>Chang-Ki</ForeName>
<Initials>CK</Initials>
<AffiliationInfo><Affiliation>Seoul St. Mary's Hospital, Seoul, Republic of Korea;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Polo Zarzuela</LastName>
<ForeName>Marta</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Hospital Clinico San Carlos, Madrid, Spain;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Robak</LastName>
<ForeName>Tadeusz</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Medical University of Lodz, Lodz, Poland;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Prasad</LastName>
<ForeName>Sripada V S S</ForeName>
<Initials>SV</Initials>
<AffiliationInfo><Affiliation>Apollo Hospitals & Research Foundation, Hyderabad, India;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tee Goh</LastName>
<ForeName>Yeow</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>Singapore General Hospital, Singapore, Singapore;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Laubach</LastName>
<ForeName>Jacob</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Dana Farber Cancer Institute, Boston, MA;</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>Mateos</LastName>
<ForeName>María-Victoria</ForeName>
<Initials>MV</Initials>
<AffiliationInfo><Affiliation>Hospital Universitario Salamanca, Salamanca, Spain;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Palumbo</LastName>
<ForeName>Antonio</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Ospedale Le Molinette, Torino, Italy;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Puchalski</LastName>
<ForeName>Tom</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Janssen Research & Development, Spring House, PA;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Reddy</LastName>
<ForeName>Manjula</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Janssen Research & Development, Spring House, PA;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Uhlar</LastName>
<ForeName>Clarissa</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Janssen Research & Development, Spring House, PA;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Qin</LastName>
<ForeName>Xiang</ForeName>
<Initials>X</Initials>
<AffiliationInfo><Affiliation>Janssen Research & Development, Spring House, PA;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>van de Velde</LastName>
<ForeName>Helgi</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Janssen Research & Development, Beerse, Belgium; and.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Xie</LastName>
<ForeName>Hong</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Janssen Research & Development, Spring House, PA;</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Orlowski</LastName>
<ForeName>Robert Z</ForeName>
<Initials>RZ</Initials>
<AffiliationInfo><Affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT00911859</AccessionNumber>
</AccessionNumberList>
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<GrantList CompleteYN="Y"><Grant><GrantID>P30 CA016672</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>P50 CA142509</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>R01 CA102278</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>UL1 TR000371</GrantID>
<Acronym>TR</Acronym>
<Agency>NCATS NIH HHS</Agency>
<Country>United States</Country>
</Grant>
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<PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
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<ArticleDate DateType="Electronic"><Year>2014</Year>
<Month>05</Month>
<Day>15</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Blood</MedlineTA>
<NlmUniqueID>7603509</NlmUniqueID>
<ISSNLinking>0006-4971</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D001897">Boronic Acids</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C508600">IL6 protein, human</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D007070">Immunoglobulin A</NameOfSubstance>
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<Chemical><RegistryNumber>0</RegistryNumber>
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<Chemical><RegistryNumber>0</RegistryNumber>
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<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C504234">siltuximab</NameOfSubstance>
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<CitationSubset>IM</CitationSubset>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName>
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{{Explor lien
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   |area=    AustralieFrV1
   |flux=    PubMed
   |étape=   Curation
   |type=    RBID
   |clé=     pubmed:24833354
   |texte=   Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma.
}}

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This area was generated with Dilib version V0.6.33.
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	Serveur d'exploration sur les relations entre la France et l'Australie
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur les relations entre la France et l'Australie

Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma.

Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma.

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