Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma

Pomalidomide is a distinct oral IMiD® immunomodulatory agent with direct antimyeloma, stromalsupport inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patien...

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Authors: San Miguel, Jesús F., Weisel, Katja C., Song, Kevin W., Delforge, Michel, Karlin, Lionel, Goldschmidt, Hartmut, Moreau, Philippe, Banos, Anne, Oriol, Albert, Garderet, Laurent, Cavo, Michele, Ivanova, Valentina, Alegre Amor, Adrián, Martínez-López, Joaquín, Chen, Chritine, Renner, Christoph, Bahlis, Nizar Jacques, Yu, Xin, Teasdale, Terri, Sternas, Lars, Jacques, Christian, Zaki, Mohamed H., Dimopoulos, Meletios A.
Format: article
Publication Date:2015
Country:España
Institution:Universidad Autónoma de Madrid
Repository:Biblos-e Archivo. Repositorio Institucional de la UAM
Language:English
OAI Identifier:oai:repositorio.uam.es:10486/672193
Online Access:http://hdl.handle.net/10486/672193
https://dx.doi.org/10.3324/haematol.2015.125864
Access Level:Open access
Keyword:MM-003
Pomalidomide
Multiple myeloma
Treatment
Medicina
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spelling Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myelomaSan Miguel, Jesús F.Weisel, Katja C.Song, Kevin W.Delforge, MichelKarlinLionelGoldschmidt, HartmutMoreau, PhilippeBanos, AnneOriol, AlbertGarderet, LaurentCavo, MicheleIvanova, ValentinaAlegre Amor, AdriánMartínez-López, JoaquínChen, ChritineRenner, ChristophBahlis, Nizar JacquesYu, XinTeasdale, TerriSternas, LarsJacques, ChristianZaki, Mohamed H.Dimopoulos, Meletios A.MM-003PomalidomideMultiple myelomaTreatmentMedicinaPomalidomide is a distinct oral IMiD® immunomodulatory agent with direct antimyeloma, stromalsupport inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and lenalidomide treatment. Initial results demonstrated significantly longer progression-free survival and overall survival with an acceptable tolerability profile for pomalidomide + low-dose dexamethasone vs high-dose dexamethasone. This secondary analysis describes patient outcomes by treatment history and depth of response. Pomalidomide + low-dose dexamethasone significantly prolonged progression-free survival and favored overall survival vs high-dose dexamethasone for all subgroups analyzed, regardless of prior treatments or refractory status. Both univariate and multivariate analyses showed that no variable relating to either the number (≤ or > 3) or type of prior treatment was a significant predictor of progression-free survival or overall survival. No cross-resistance with prior lenalidomide or thalidomide treatment was observed. Patients achieving a minimal response or better to pomalidomide + low-dose dexamethasone treatment experienced a survival benefit, which was even higher in those achieving at least a partial response (17.2 and 19.9 months, respectively, as compared with 7.5 months for patients with less than minimal response). These data suggest that pomalidomide + low-dose dexamethasone should be considered a standard of care in patients with refractory or relapsed and refractory multiple myeloma regardless of prior treatmentFerrata Storti FoundationDepartamento de MedicinaFacultad de MedicinaInstituto de Investigación del Hospital de La Princesa (IP)20152015-01-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10486/672193https://dx.doi.org/10.3324/haematol.2015.125864reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/6721932026-06-23T12:46:27Z
dc.title.none.fl_str_mv Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
title Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
spellingShingle Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
San Miguel, Jesús F.
MM-003
Pomalidomide
Multiple myeloma
Treatment
Medicina
title_short Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
title_full Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
title_fullStr Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
title_full_unstemmed Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
title_sort Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
dc.creator.none.fl_str_mv San Miguel, Jesús F.
Weisel, Katja C.
Song, Kevin W.
Delforge, Michel
Karlin
Lionel
Goldschmidt, Hartmut
Moreau, Philippe
Banos, Anne
Oriol, Albert
Garderet, Laurent
Cavo, Michele
Ivanova, Valentina
Alegre Amor, Adrián
Martínez-López, Joaquín
Chen, Chritine
Renner, Christoph
Bahlis, Nizar Jacques
Yu, Xin
Teasdale, Terri
Sternas, Lars
Jacques, Christian
Zaki, Mohamed H.
Dimopoulos, Meletios A.
author San Miguel, Jesús F.
author_facet San Miguel, Jesús F.
Weisel, Katja C.
Song, Kevin W.
Delforge, Michel
Karlin
Lionel
Goldschmidt, Hartmut
Moreau, Philippe
Banos, Anne
Oriol, Albert
Garderet, Laurent
Cavo, Michele
Ivanova, Valentina
Alegre Amor, Adrián
Martínez-López, Joaquín
Chen, Chritine
Renner, Christoph
Bahlis, Nizar Jacques
Yu, Xin
Teasdale, Terri
Sternas, Lars
Jacques, Christian
Zaki, Mohamed H.
Dimopoulos, Meletios A.
author_role author
author2 Weisel, Katja C.
Song, Kevin W.
Delforge, Michel
Karlin
Lionel
Goldschmidt, Hartmut
Moreau, Philippe
Banos, Anne
Oriol, Albert
Garderet, Laurent
Cavo, Michele
Ivanova, Valentina
Alegre Amor, Adrián
Martínez-López, Joaquín
Chen, Chritine
Renner, Christoph
Bahlis, Nizar Jacques
Yu, Xin
Teasdale, Terri
Sternas, Lars
Jacques, Christian
Zaki, Mohamed H.
Dimopoulos, Meletios A.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Departamento de Medicina
Facultad de Medicina
Instituto de Investigación del Hospital de La Princesa (IP)
dc.subject.none.fl_str_mv MM-003
Pomalidomide
Multiple myeloma
Treatment
Medicina
topic MM-003
Pomalidomide
Multiple myeloma
Treatment
Medicina
description Pomalidomide is a distinct oral IMiD® immunomodulatory agent with direct antimyeloma, stromalsupport inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and lenalidomide treatment. Initial results demonstrated significantly longer progression-free survival and overall survival with an acceptable tolerability profile for pomalidomide + low-dose dexamethasone vs high-dose dexamethasone. This secondary analysis describes patient outcomes by treatment history and depth of response. Pomalidomide + low-dose dexamethasone significantly prolonged progression-free survival and favored overall survival vs high-dose dexamethasone for all subgroups analyzed, regardless of prior treatments or refractory status. Both univariate and multivariate analyses showed that no variable relating to either the number (≤ or > 3) or type of prior treatment was a significant predictor of progression-free survival or overall survival. No cross-resistance with prior lenalidomide or thalidomide treatment was observed. Patients achieving a minimal response or better to pomalidomide + low-dose dexamethasone treatment experienced a survival benefit, which was even higher in those achieving at least a partial response (17.2 and 19.9 months, respectively, as compared with 7.5 months for patients with less than minimal response). These data suggest that pomalidomide + low-dose dexamethasone should be considered a standard of care in patients with refractory or relapsed and refractory multiple myeloma regardless of prior treatment
publishDate 2015
dc.date.none.fl_str_mv 2015
2015-01-01
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/10486/672193
https://dx.doi.org/10.3324/haematol.2015.125864
url http://hdl.handle.net/10486/672193
https://dx.doi.org/10.3324/haematol.2015.125864
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Ferrata Storti Foundation
publisher.none.fl_str_mv Ferrata Storti Foundation
dc.source.none.fl_str_mv reponame:Biblos-e Archivo. Repositorio Institucional de la UAM
instname:Universidad Autónoma de Madrid
instname_str Universidad Autónoma de Madrid
reponame_str Biblos-e Archivo. Repositorio Institucional de la UAM
collection Biblos-e Archivo. Repositorio Institucional de la UAM
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300719

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