ArticleBritish journal of haematology2016
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.
Article in British journal of haematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
20 citing papers in PubMed, 52 citations in OpenAlex.
- 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.Journal of clinical pharmacology · 2018Trial
- Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses.Targeted oncology · 2017Trial
- Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.British journal of haematology · 2017Trial
- Phase I study of TQB3602, an oral proteasome inhibitor, in relapsed and refractory multiple myeloma.Cancer medicine · 2024Article
- Practical management of disease-related manifestations and drug toxicities in patients with multiple myeloma.Frontiers in oncology · 2024Review
- Organoboronic acids/esters as effective drug and prodrug candidates in cancer treatments: challenge and hope.Journal of enzyme inhibition and medicinal chemistry · 2023Review
- Partnering With All Patients: Ensuring Shared Decision Making and Evidence-Based Management for Underrepresented Groups With Multiple Myeloma.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2023Article
- Multiple myeloma with acute light chain cast nephropathy.Blood cancer journal · 2023Review
- An overview of treatment options for patients with relapsed/refractory multiple myeloma and renal impairment.Therapeutic advances in hematology · 2022Review
- Review
- A pilot study of 3D tissue-engineered bone marrow culture as a tool to predict patient response to therapy in multiple myeloma.Scientific reports · 2021Observational
- A comparison of the efficacy and safety of ixazomib and lenalidomide combined with dexamethasone in the treatment of multiple myeloma.American journal of translational research · 2021Article
- Pharmacodynamics and pharmacokinetics of proteasome inhibitors for the treatment of multiple myeloma.Expert opinion on drug metabolism & toxicology · 2019Review
- Clinical Pharmacology of Ixazomib: The First Oral Proteasome Inhibitor.Clinical pharmacokinetics · 2019Review
- Model-Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor.Clinical pharmacology and therapeutics · 2019Review
- A phase I study to assess the mass balance, excretion, and pharmacokinetics of [Investigational new drugs · 2018Article
- Population Pharmacokinetic Analysis of Ixazomib, an Oral Proteasome Inhibitor, Including Data from the Phase III TOURMALINE-MM1 Study to Inform Labelling.Clinical pharmacokinetics · 2017Article
- Ixazomib: A Review in Relapsed and/or Refractory Multiple Myeloma.Targeted oncology · 2017Review
- New developments in the management of relapsed/refractory multiple myeloma - the role of ixazomib.Journal of blood medicine · 2017Review
- Safety and Effectiveness of Ixazomib Dose-escalating Strategy in Ixazomib-Lenalidomide-Dexamethasone Treatment for Relapsed/Refractory Multiple Myeloma.In vivo (Athens, Greece)Article
Corrections and comments
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Authors and funding
13 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Renal impairment (RI) is a major complication of multiple myeloma (MM). This study aimed to characterize the single-dose pharmacokinetics (PK) of the oral proteasome inhibitor, ixazomib, in cancer patients with normal renal function [creatinine clearance (CrCl) ≥90 ml/min; n = 20), severe RI (CrCl <30 ml/min; n = 14), or end-stage renal disease requiring haemodialysis (ESRD; n = 7). PK and adverse events (AEs) were assessed after a single 3 mg dose of ixazomib. Ixazomib was highly bound to plasma proteins (~99%) in all renal function groups. Unbound and total systemic exposures of ixazomib were 38% and 39% higher, respectively, in severe RI/ESRD patients versus patients with normal renal function. Total ixazomib concentrations were similar in pre- and post-dialyser samples collected from ESRD patients; therefore, ixazomib can be administered without regard to haemodialysis timing. Except for anaemia, the incidence of the most common AEs was generally similar across groups, but grade 3 and 4 AEs were more frequent in the severe RI/ESRD groups versus the normal group (79%/57% vs. 45%), as were serious AEs (43%/43% vs. 15%). The PK and safety results support a reduced ixazomib dose of 3 mg in patients with severe RI/ESRD.
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