A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma
© 2021 The Authors.
| Autores: | , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Consejo Superior de Investigaciones Científicas (CSIC) |
| Repositorio: | DIGITAL.CSIC. Repositorio Institucional del CSIC |
| OAI Identifier: | oai:digital.csic.es:10261/261010 |
| Acceso en línea: | http://hdl.handle.net/10261/261010 |
| Access Level: | acceso abierto |
| Palabra clave: | BCL2 Immunomodulatory agents Plasma cell dyscrasia Targeted therapy Venetoclax |
| id |
ES_02c079decee540d2a649e0922e1e8e33 |
|---|---|
| oai_identifier_str |
oai:digital.csic.es:10261/261010 |
| network_acronym_str |
ES |
| network_name_str |
España |
| repository_id_str |
|
| spelling |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple MyelomaGasparetto, CristinaBowles, Kristian M.Abdallah, Al-OlaMorris, LuraMander, GudrunCoppola, SherylWang, J.Ross, J. A.Bueno, Orlando F.Arriola, EmmaMateos, Maria VictoriaBCL2Immunomodulatory agentsPlasma cell dyscrasiaTargeted therapyVenetoclax© 2021 The Authors.[Background]: Venetoclax is a selective BCL-2 inhibitor with clinical activity in relapsed/refractory multiple myeloma (RRMM). Combinations of venetoclax with agents that have complementary mechanisms of action may improve venetoclax efficacy in RRMM. This study evaluated venetoclax with pomalidomide and dexamethasone (VenPd) in RRMM. [Patients and Methods]: This phase II open label study (NCT03567616) evaluated VenPd in patients with RRMM who had received ≥ 1 prior therapy and were refractory to lenalidomide. Venetoclax was administered orally daily for days 1 to 28, pomalidomide was administered orally daily for days 1 to 21, and dexamethasone was administered weekly for each 28-day cycle. The primary objective was to characterize the safety and tolerability of VenPd. The secondary objectives were to evaluate the efficacy and pharmacokinetics. The study was terminated early due to partial clinical hold and decision to pursue biomarker driven strategy. [Results]: Eight patients were enrolled. Patients had a median age of 67.5 years. All patients received 400 mg venetoclax; 4 patients experienced dose-limiting toxicities and the dose was not escalated. All patients had a grade ≥ 3 adverse event, and the most common was neutropenia (n = 6); cytopenias were the most prevalent adverse events. Five patients (63%) had a confirmed response, and the median duration of response was 12.9 months. The median progression-free survival was 10.5 months. [Conclusions]: Given the limited enrollment, no clear safety or efficacy conclusions about VenPd can be drawn. Preliminary safety data, particularly the occurrence of cytopenias, can be used to guide dosing strategies for future combinations of venetoclax with immunomodulatory agents.AbbVie Inc is a private corporation, and funding is not associated with a grant number. Funding information is correct as stated.ElsevierAbbVie PharmaceuticalsConsejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]2022202220212022info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10261/261010reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Ingléshttp://dx.doi.org/10.1016/j.clml.2021.07.029Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/2610102026-05-22T06:33:51Z |
| dc.title.none.fl_str_mv |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma |
| title |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma |
| spellingShingle |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma Gasparetto, Cristina BCL2 Immunomodulatory agents Plasma cell dyscrasia Targeted therapy Venetoclax |
| title_short |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma |
| title_full |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma |
| title_fullStr |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma |
| title_full_unstemmed |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma |
| title_sort |
A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma |
| dc.creator.none.fl_str_mv |
Gasparetto, Cristina Bowles, Kristian M. Abdallah, Al-Ola Morris, Lura Mander, Gudrun Coppola, Sheryl Wang, J. Ross, J. A. Bueno, Orlando F. Arriola, Emma Mateos, Maria Victoria |
| author |
Gasparetto, Cristina |
| author_facet |
Gasparetto, Cristina Bowles, Kristian M. Abdallah, Al-Ola Morris, Lura Mander, Gudrun Coppola, Sheryl Wang, J. Ross, J. A. Bueno, Orlando F. Arriola, Emma Mateos, Maria Victoria |
| author_role |
author |
| author2 |
Bowles, Kristian M. Abdallah, Al-Ola Morris, Lura Mander, Gudrun Coppola, Sheryl Wang, J. Ross, J. A. Bueno, Orlando F. Arriola, Emma Mateos, Maria Victoria |
| author2_role |
author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
AbbVie Pharmaceuticals Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72] |
| dc.subject.none.fl_str_mv |
BCL2 Immunomodulatory agents Plasma cell dyscrasia Targeted therapy Venetoclax |
| topic |
BCL2 Immunomodulatory agents Plasma cell dyscrasia Targeted therapy Venetoclax |
| description |
© 2021 The Authors. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021 2022 2022 2022 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article http://purl.org/coar/resource_type/c_6501 Publisher's version info:eu-repo/semantics/publishedVersion |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
http://hdl.handle.net/10261/261010 |
| url |
http://hdl.handle.net/10261/261010 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
http://dx.doi.org/10.1016/j.clml.2021.07.029 Sí |
| dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.publisher.none.fl_str_mv |
Elsevier |
| publisher.none.fl_str_mv |
Elsevier |
| dc.source.none.fl_str_mv |
reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC instname:Consejo Superior de Investigaciones Científicas (CSIC) |
| instname_str |
Consejo Superior de Investigaciones Científicas (CSIC) |
| reponame_str |
DIGITAL.CSIC. Repositorio Institucional del CSIC |
| collection |
DIGITAL.CSIC. Repositorio Institucional del CSIC |
| repository.name.fl_str_mv |
|
| repository.mail.fl_str_mv |
|
| _version_ |
1869402676106625024 |
| score |
15,811543 |