Cargando…

Population pharmacokinetic/pharmacodynamic joint modeling of ixazomib efficacy and safety using data from the pivotal phase III TOURMALINE‐MM1 study in multiple myeloma patients

Ixazomib is an oral proteasome inhibitor approved in combination with lenalidomide and dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM). Approval in the United States, Europe, and additional countries was based on results from the phase III TOURMALINE‐MM1 (C16010) study....

Descripción completa

Detalles Bibliográficos
Autores principales:	Srimani, Jaydeep K., Diderichsen, Paul M., Hanley, Michael J., Venkatakrishnan, Karthik, Labotka, Richard, Gupta, Neeraj
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2022
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9381907/ https://www.ncbi.nlm.nih.gov/pubmed/35598166 http://dx.doi.org/10.1002/psp4.12815

Ejemplares similares

Population Pharmacokinetic Analysis of Ixazomib, an Oral Proteasome Inhibitor, Including Data from the Phase III TOURMALINE-MM1 Study to Inform Labelling
por: Gupta, Neeraj, et al.
Publicado: (2017)

Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma
por: Kaiser, Martin, et al.
Publicado: (2020)

Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial
por: Dimopoulos, Meletios A., et al.
Publicado: (2020)

Impact of ixazomib‐lenalidomide‐dexamethasone therapy on overall survival in multiple myeloma patients: Analysis of the emerging‐markets subgroup of the TOURMALINE‐MM1 trial
por: Spencer, Andrew, et al.
Publicado: (2022)

Clinical Pharmacology of Ixazomib: The First Oral Proteasome Inhibitor
por: Gupta, Neeraj, et al.
Publicado: (2018)

Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
por: Gupta, Neeraj, et al.
Publicado: (2018)

Pharmacokinetics of ixazomib, an oral proteasome inhibitor, in solid tumour patients with moderate or severe hepatic impairment
por: Gupta, Neeraj, et al.
Publicado: (2016)

Exposure–safety–efficacy analysis of single-agent ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma: dose selection for a phase 3 maintenance study
por: Gupta, Neeraj, et al.
Publicado: (2016)

MRD dynamics during maintenance for improved prognostication of 1280 patients with myeloma in the TOURMALINE-MM3 and -MM4 trials
por: Paiva, Bruno, et al.
Publicado: (2023)

Impact of prior therapy on the efficacy and safety of oral ixazomib-lenalidomide-dexamethasone vs. placebo-lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in TOURMALINE-MM1
por: Mateos, María-Victoria, et al.
Publicado: (2017)

Pharmacokinetics and safety of ixazomib plus lenalidomide–dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 study
por: Gupta, Neeraj, et al.
Publicado: (2015)

The Effect of a High‐Fat Meal on the Pharmacokinetics of Ixazomib, an Oral Proteasome Inhibitor, in Patients With Advanced Solid Tumors or Lymphoma
por: Gupta, Neeraj, et al.
Publicado: (2016)

Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses
por: Gupta, Neeraj, et al.
Publicado: (2017)

A pharmacokinetics and safety phase 1/1b study of oral ixazomib in patients with multiple myeloma and severe renal impairment or end‐stage renal disease requiring haemodialysis
por: Gupta, Neeraj, et al.
Publicado: (2016)

Late versus early response and depth of response are associated with improved outcomes in patients with newly diagnosed multiple myeloma enrolled in the TOURMALINE‐MM2 trial
por: Richardson, Paul G., et al.
Publicado: (2023)

Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model‐Informed Dose Selection for Pediatric Development
por: Hanley, Michael J., et al.
Publicado: (2021)

Association between response kinetics and outcomes in relapsed/refractory multiple myeloma: analysis from TOURMALINE-MM1
por: Garderet, Laurent, et al.
Publicado: (2018)

Brigatinib Dose Rationale in Anaplastic Lymphoma Kinase–Positive Non‐Small Cell Lung Cancer: Exposure–Response Analyses of Pivotal ALTA Study
por: Gupta, Neeraj, et al.
Publicado: (2020)

A phase I study to assess the mass balance, excretion, and pharmacokinetics of [(14)C]-ixazomib, an oral proteasome inhibitor, in patients with advanced solid tumors
por: Gupta, Neeraj, et al.
Publicado: (2017)

Deepening responses associated with improved progression-free survival with ixazomib versus placebo as posttransplant maintenance in multiple myeloma
por: Goldschmidt, Hartmut, et al.
Publicado: (2020)

Model‐Based Meta‐Analysis for Multiple Myeloma: A Quantitative Drug‐Independent Framework for Efficient Decisions in Oncology Drug Development
por: Teng, Zhaoyang, et al.
Publicado: (2017)

Effects of Strong CYP3A Inhibition and Induction on the Pharmacokinetics of Ixazomib, an Oral Proteasome Inhibitor: Results of Drug‐Drug Interaction Studies in Patients With Advanced Solid Tumors or Lymphoma and a Physiologically Based Pharmacokinetic Analysis
por: Gupta, Neeraj, et al.
Publicado: (2017)

New developments in the management of relapsed/refractory multiple myeloma – the role of ixazomib
por: Richardson, Paul G, et al.
Publicado: (2017)

Physiologically‐Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study
por: Rowland Yeo, Karen, et al.
Publicado: (2020)

Spotlight on ixazomib: potential in the treatment of multiple myeloma
por: Muz, Barbara, et al.
Publicado: (2016)

T‐cell pseudolymphoma secondary to ixazomib for multiple myeloma
por: Haq, M., et al.
Publicado: (2021)

Ixazomib: An Oral Proteasome Inhibitor for the Treatment of Multiple Myeloma
por: Ramirez, Krista G.
Publicado: (2017)

Accidental Ixazomib Overdose in a Patient With Multiple Myeloma
por: Sampat, Parth J., et al.
Publicado: (2021)

Ixazomib–Thalidomide–Dexamethasone for induction therapy followed by Ixazomib maintenance treatment in patients with relapsed/refractory multiple myeloma
por: Ludwig, Heinz, et al.
Publicado: (2019)

Effect of severe renal impairment on the pharmacokinetics of brigatinib
por: Gupta, Neeraj, et al.
Publicado: (2021)

Brigatinib pharmacokinetics in patients with chronic hepatic impairment
por: Hanley, Michael J., et al.
Publicado: (2023)

Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study
por: Hou, Jian, et al.
Publicado: (2017)

Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma: long-term follow-up including ixazomib maintenance
por: Kumar, Shaji K., et al.
Publicado: (2019)

A pooled analysis of outcomes according to cytogenetic abnormalities in patients receiving ixazomib- vs placebo-based therapy for multiple myeloma
por: Chng, Wee-Joo, et al.
Publicado: (2023)

Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial
por: Dimopoulos, Meletios A., et al.
Publicado: (2022)

Population Pharmacokinetics of Brigatinib in Healthy Volunteers and Patients With Cancer
por: Gupta, Neeraj, et al.
Publicado: (2020)

Twice‐weekly ixazomib in combination with lenalidomide‐dexamethasone in patients with newly diagnosed multiple myeloma
por: Richardson, Paul G., et al.
Publicado: (2018)

Comparison between ixazomib+cyclophosphamide+dexamethasone regimen and ixazomib+dexamethasone regimen for elderly and frail patients having newly diagnosed multiple myeloma
por: Li, Shutan, et al.
Publicado: (2022)

Stem Cell Mobilization with Ixazomib and G-CSF in Patients with Multiple Myeloma
por: Bühler, Selina, et al.
Publicado: (2023)

Population pharmacokinetics of mobocertinib in healthy volunteers and patients with non–small cell lung cancer
por: Gupta, Neeraj, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_nou3goips8rv60a5b8mqqtpda6