Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics

Objective: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse. Methods: OPTIMISMM was...

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Autores: Richardson, P.G. (Paul G.)|||/items/4a03f76e-f4e1-4490-8091-a79e8ea86861, Schjesvold, F.H. (Fredrik H.)|||/items/b6f53b4f-ff1f-46e1-9e11-839338bb0acf, Weisel, K. (Katja)|||/items/2b91c472-77fe-41ac-888c-5b2e0c5d7197, Moreau, P. (Philippe)|||/items/3d8d9f42-9629-4e12-9854-43031d9b6332, Anderson Jr, L.D. (Larry D.)|||/items/58dbcbfe-8a2e-4162-9111-ac3a73c8a385, White, D.J. (Darrell J.)|||/items/a236840a-3131-47d9-a250-fab9b100d5a7, Rodriguez-Otero, P. (Paula)|||/items/bb21b679-c3ea-4d5a-9939-f330219406c8, Sonneveld, P. (Pieter)|||/items/24063b12-1f63-4151-b5b3-36d4a255dbc8, Engelhardt, M. (Monika)|||/items/19022ea7-5d61-41b2-8552-38296d8afb2c, Jenner, M. (Matthew)|||/items/2343c9a9-e8e0-4e33-87b8-4a79bf38c426, Corso, A. (Alessandro)|||/items/5e03ae39-0975-4c4a-adc0-0e06b28e4a97, Dürig, J. (Jan)|||/items/26998797-f9a7-4609-a0e7-45a958633fbc, Pavic, M. (Michel)|||/items/eb7d2861-f287-481f-8261-ba417c533888, Salomo, M. (Morten)|||/items/5f058b3e-81a8-478f-bce0-614903eba185, Beksac, M. (Meral)|||/items/705a45fb-336b-4552-ab63-514429511250, Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400, Lindsay, J. (Jindriska)|||/items/a79ea676-6c54-462e-b27f-b3e55e0584d5, Liberati, A.M. (Anna Marina)|||/items/3f7bc77c-49d1-4631-8870-eed66ec3c092, Galli, M. (Monica)|||/items/e90891ca-fc2c-49bc-9938-4af1263ed95f, Robak, P. (Pawel)|||/items/5af30845-f3b2-463b-8cef-9d8f28dcbfcc, Larocca, A. (Alessandra)|||/items/59188868-eae2-4953-b71a-20c7032200af, Yagci, M. (Munci)|||/items/e68944e0-257e-433b-bb06-c21c74b53065, Vural, F. (Filiz)|||/items/5ea0908e-2b21-47ac-9a39-24af59b60b1e, Kanate, A.S. (Abraham S.)|||/items/6c211c11-288e-47df-b241-ef0a19fc65ef, Jiang, R. (Ruiyun)|||/items/a1624f11-2241-48e3-b83b-d2daab3eb4cf, Grote, L. (Lara)|||/items/070f899a-1aaa-41e2-b93c-fbeb22059de5, Peluso, T. (Teresa)|||/items/d87d0f49-ed0c-4593-b57f-19a24949661f, Dimopoulos, M.A. (Meletios A.)|||/items/15a77e11-69c3-44a2-8476-eb93bbe8cc0e
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universidad de Navarra
Repositorio:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:inglés
OAI Identifier:oai:dadun.unav.edu:10171/119728
Acceso en línea:https://hdl.handle.net/10171/119728
Access Level:acceso abierto
Palabra clave:Aged
Chromosome aberrations
Multiple myeloma
Pomalidomide
Renal insufficiency
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spelling Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristicsRichardson, P.G. (Paul G.)|||/items/4a03f76e-f4e1-4490-8091-a79e8ea86861Schjesvold, F.H. (Fredrik H.)|||/items/b6f53b4f-ff1f-46e1-9e11-839338bb0acfWeisel, K. (Katja)|||/items/2b91c472-77fe-41ac-888c-5b2e0c5d7197Moreau, P. (Philippe)|||/items/3d8d9f42-9629-4e12-9854-43031d9b6332Anderson Jr, L.D. (Larry D.)|||/items/58dbcbfe-8a2e-4162-9111-ac3a73c8a385White, D.J. (Darrell J.)|||/items/a236840a-3131-47d9-a250-fab9b100d5a7Rodriguez-Otero, P. (Paula)|||/items/bb21b679-c3ea-4d5a-9939-f330219406c8Sonneveld, P. (Pieter)|||/items/24063b12-1f63-4151-b5b3-36d4a255dbc8Engelhardt, M. (Monika)|||/items/19022ea7-5d61-41b2-8552-38296d8afb2cJenner, M. (Matthew)|||/items/2343c9a9-e8e0-4e33-87b8-4a79bf38c426Corso, A. (Alessandro)|||/items/5e03ae39-0975-4c4a-adc0-0e06b28e4a97Dürig, J. (Jan)|||/items/26998797-f9a7-4609-a0e7-45a958633fbcPavic, M. (Michel)|||/items/eb7d2861-f287-481f-8261-ba417c533888Salomo, M. (Morten)|||/items/5f058b3e-81a8-478f-bce0-614903eba185Beksac, M. (Meral)|||/items/705a45fb-336b-4552-ab63-514429511250Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400Lindsay, J. (Jindriska)|||/items/a79ea676-6c54-462e-b27f-b3e55e0584d5Liberati, A.M. (Anna Marina)|||/items/3f7bc77c-49d1-4631-8870-eed66ec3c092Galli, M. (Monica)|||/items/e90891ca-fc2c-49bc-9938-4af1263ed95fRobak, P. (Pawel)|||/items/5af30845-f3b2-463b-8cef-9d8f28dcbfccLarocca, A. (Alessandra)|||/items/59188868-eae2-4953-b71a-20c7032200afYagci, M. (Munci)|||/items/e68944e0-257e-433b-bb06-c21c74b53065Vural, F. (Filiz)|||/items/5ea0908e-2b21-47ac-9a39-24af59b60b1eKanate, A.S. (Abraham S.)|||/items/6c211c11-288e-47df-b241-ef0a19fc65efJiang, R. (Ruiyun)|||/items/a1624f11-2241-48e3-b83b-d2daab3eb4cfGrote, L. (Lara)|||/items/070f899a-1aaa-41e2-b93c-fbeb22059de5Peluso, T. (Teresa)|||/items/d87d0f49-ed0c-4593-b57f-19a24949661fDimopoulos, M.A. (Meletios A.)|||/items/15a77e11-69c3-44a2-8476-eb93bbe8cc0eAgedChromosome aberrationsMultiple myelomaPomalidomideRenal insufficiencyObjective: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse. Methods: OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS). Results: Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports. Conclusions: These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.Wiley Periodicals LLC.Dadun. Depósito Académico Digital Universidad de Navarra20222022-01-0120222022-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/119728reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/1197282026-06-21T12:47:57Z
dc.title.none.fl_str_mv Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
title Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
spellingShingle Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
Richardson, P.G. (Paul G.)|||/items/4a03f76e-f4e1-4490-8091-a79e8ea86861
Aged
Chromosome aberrations
Multiple myeloma
Pomalidomide
Renal insufficiency
title_short Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
title_full Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
title_fullStr Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
title_full_unstemmed Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
title_sort Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
dc.creator.none.fl_str_mv Richardson, P.G. (Paul G.)|||/items/4a03f76e-f4e1-4490-8091-a79e8ea86861
Schjesvold, F.H. (Fredrik H.)|||/items/b6f53b4f-ff1f-46e1-9e11-839338bb0acf
Weisel, K. (Katja)|||/items/2b91c472-77fe-41ac-888c-5b2e0c5d7197
Moreau, P. (Philippe)|||/items/3d8d9f42-9629-4e12-9854-43031d9b6332
Anderson Jr, L.D. (Larry D.)|||/items/58dbcbfe-8a2e-4162-9111-ac3a73c8a385
White, D.J. (Darrell J.)|||/items/a236840a-3131-47d9-a250-fab9b100d5a7
Rodriguez-Otero, P. (Paula)|||/items/bb21b679-c3ea-4d5a-9939-f330219406c8
Sonneveld, P. (Pieter)|||/items/24063b12-1f63-4151-b5b3-36d4a255dbc8
Engelhardt, M. (Monika)|||/items/19022ea7-5d61-41b2-8552-38296d8afb2c
Jenner, M. (Matthew)|||/items/2343c9a9-e8e0-4e33-87b8-4a79bf38c426
Corso, A. (Alessandro)|||/items/5e03ae39-0975-4c4a-adc0-0e06b28e4a97
Dürig, J. (Jan)|||/items/26998797-f9a7-4609-a0e7-45a958633fbc
Pavic, M. (Michel)|||/items/eb7d2861-f287-481f-8261-ba417c533888
Salomo, M. (Morten)|||/items/5f058b3e-81a8-478f-bce0-614903eba185
Beksac, M. (Meral)|||/items/705a45fb-336b-4552-ab63-514429511250
Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400
Lindsay, J. (Jindriska)|||/items/a79ea676-6c54-462e-b27f-b3e55e0584d5
Liberati, A.M. (Anna Marina)|||/items/3f7bc77c-49d1-4631-8870-eed66ec3c092
Galli, M. (Monica)|||/items/e90891ca-fc2c-49bc-9938-4af1263ed95f
Robak, P. (Pawel)|||/items/5af30845-f3b2-463b-8cef-9d8f28dcbfcc
Larocca, A. (Alessandra)|||/items/59188868-eae2-4953-b71a-20c7032200af
Yagci, M. (Munci)|||/items/e68944e0-257e-433b-bb06-c21c74b53065
Vural, F. (Filiz)|||/items/5ea0908e-2b21-47ac-9a39-24af59b60b1e
Kanate, A.S. (Abraham S.)|||/items/6c211c11-288e-47df-b241-ef0a19fc65ef
Jiang, R. (Ruiyun)|||/items/a1624f11-2241-48e3-b83b-d2daab3eb4cf
Grote, L. (Lara)|||/items/070f899a-1aaa-41e2-b93c-fbeb22059de5
Peluso, T. (Teresa)|||/items/d87d0f49-ed0c-4593-b57f-19a24949661f
Dimopoulos, M.A. (Meletios A.)|||/items/15a77e11-69c3-44a2-8476-eb93bbe8cc0e
author Richardson, P.G. (Paul G.)|||/items/4a03f76e-f4e1-4490-8091-a79e8ea86861
author_facet Richardson, P.G. (Paul G.)|||/items/4a03f76e-f4e1-4490-8091-a79e8ea86861
Schjesvold, F.H. (Fredrik H.)|||/items/b6f53b4f-ff1f-46e1-9e11-839338bb0acf
Weisel, K. (Katja)|||/items/2b91c472-77fe-41ac-888c-5b2e0c5d7197
Moreau, P. (Philippe)|||/items/3d8d9f42-9629-4e12-9854-43031d9b6332
Anderson Jr, L.D. (Larry D.)|||/items/58dbcbfe-8a2e-4162-9111-ac3a73c8a385
White, D.J. (Darrell J.)|||/items/a236840a-3131-47d9-a250-fab9b100d5a7
Rodriguez-Otero, P. (Paula)|||/items/bb21b679-c3ea-4d5a-9939-f330219406c8
Sonneveld, P. (Pieter)|||/items/24063b12-1f63-4151-b5b3-36d4a255dbc8
Engelhardt, M. (Monika)|||/items/19022ea7-5d61-41b2-8552-38296d8afb2c
Jenner, M. (Matthew)|||/items/2343c9a9-e8e0-4e33-87b8-4a79bf38c426
Corso, A. (Alessandro)|||/items/5e03ae39-0975-4c4a-adc0-0e06b28e4a97
Dürig, J. (Jan)|||/items/26998797-f9a7-4609-a0e7-45a958633fbc
Pavic, M. (Michel)|||/items/eb7d2861-f287-481f-8261-ba417c533888
Salomo, M. (Morten)|||/items/5f058b3e-81a8-478f-bce0-614903eba185
Beksac, M. (Meral)|||/items/705a45fb-336b-4552-ab63-514429511250
Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400
Lindsay, J. (Jindriska)|||/items/a79ea676-6c54-462e-b27f-b3e55e0584d5
Liberati, A.M. (Anna Marina)|||/items/3f7bc77c-49d1-4631-8870-eed66ec3c092
Galli, M. (Monica)|||/items/e90891ca-fc2c-49bc-9938-4af1263ed95f
Robak, P. (Pawel)|||/items/5af30845-f3b2-463b-8cef-9d8f28dcbfcc
Larocca, A. (Alessandra)|||/items/59188868-eae2-4953-b71a-20c7032200af
Yagci, M. (Munci)|||/items/e68944e0-257e-433b-bb06-c21c74b53065
Vural, F. (Filiz)|||/items/5ea0908e-2b21-47ac-9a39-24af59b60b1e
Kanate, A.S. (Abraham S.)|||/items/6c211c11-288e-47df-b241-ef0a19fc65ef
Jiang, R. (Ruiyun)|||/items/a1624f11-2241-48e3-b83b-d2daab3eb4cf
Grote, L. (Lara)|||/items/070f899a-1aaa-41e2-b93c-fbeb22059de5
Peluso, T. (Teresa)|||/items/d87d0f49-ed0c-4593-b57f-19a24949661f
Dimopoulos, M.A. (Meletios A.)|||/items/15a77e11-69c3-44a2-8476-eb93bbe8cc0e
author_role author
author2 Schjesvold, F.H. (Fredrik H.)|||/items/b6f53b4f-ff1f-46e1-9e11-839338bb0acf
Weisel, K. (Katja)|||/items/2b91c472-77fe-41ac-888c-5b2e0c5d7197
Moreau, P. (Philippe)|||/items/3d8d9f42-9629-4e12-9854-43031d9b6332
Anderson Jr, L.D. (Larry D.)|||/items/58dbcbfe-8a2e-4162-9111-ac3a73c8a385
White, D.J. (Darrell J.)|||/items/a236840a-3131-47d9-a250-fab9b100d5a7
Rodriguez-Otero, P. (Paula)|||/items/bb21b679-c3ea-4d5a-9939-f330219406c8
Sonneveld, P. (Pieter)|||/items/24063b12-1f63-4151-b5b3-36d4a255dbc8
Engelhardt, M. (Monika)|||/items/19022ea7-5d61-41b2-8552-38296d8afb2c
Jenner, M. (Matthew)|||/items/2343c9a9-e8e0-4e33-87b8-4a79bf38c426
Corso, A. (Alessandro)|||/items/5e03ae39-0975-4c4a-adc0-0e06b28e4a97
Dürig, J. (Jan)|||/items/26998797-f9a7-4609-a0e7-45a958633fbc
Pavic, M. (Michel)|||/items/eb7d2861-f287-481f-8261-ba417c533888
Salomo, M. (Morten)|||/items/5f058b3e-81a8-478f-bce0-614903eba185
Beksac, M. (Meral)|||/items/705a45fb-336b-4552-ab63-514429511250
Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400
Lindsay, J. (Jindriska)|||/items/a79ea676-6c54-462e-b27f-b3e55e0584d5
Liberati, A.M. (Anna Marina)|||/items/3f7bc77c-49d1-4631-8870-eed66ec3c092
Galli, M. (Monica)|||/items/e90891ca-fc2c-49bc-9938-4af1263ed95f
Robak, P. (Pawel)|||/items/5af30845-f3b2-463b-8cef-9d8f28dcbfcc
Larocca, A. (Alessandra)|||/items/59188868-eae2-4953-b71a-20c7032200af
Yagci, M. (Munci)|||/items/e68944e0-257e-433b-bb06-c21c74b53065
Vural, F. (Filiz)|||/items/5ea0908e-2b21-47ac-9a39-24af59b60b1e
Kanate, A.S. (Abraham S.)|||/items/6c211c11-288e-47df-b241-ef0a19fc65ef
Jiang, R. (Ruiyun)|||/items/a1624f11-2241-48e3-b83b-d2daab3eb4cf
Grote, L. (Lara)|||/items/070f899a-1aaa-41e2-b93c-fbeb22059de5
Peluso, T. (Teresa)|||/items/d87d0f49-ed0c-4593-b57f-19a24949661f
Dimopoulos, M.A. (Meletios A.)|||/items/15a77e11-69c3-44a2-8476-eb93bbe8cc0e
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dc.contributor.none.fl_str_mv Dadun. Depósito Académico Digital Universidad de Navarra
dc.subject.none.fl_str_mv Aged
Chromosome aberrations
Multiple myeloma
Pomalidomide
Renal insufficiency
topic Aged
Chromosome aberrations
Multiple myeloma
Pomalidomide
Renal insufficiency
description Objective: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse. Methods: OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS). Results: Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports. Conclusions: These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.
publishDate 2022
dc.date.none.fl_str_mv 2022
2022-01-01
2022
2022-01-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/10171/119728
url https://hdl.handle.net/10171/119728
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 Wiley Periodicals LLC.
publisher.none.fl_str_mv Wiley Periodicals LLC.
dc.source.none.fl_str_mv reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra
instname:Universidad de Navarra
instname_str Universidad de Navarra
reponame_str Dadun. Depósito Académico Digital de la Universidad de Navarra
collection Dadun. Depósito Académico Digital de la Universidad de Navarra
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