Pharmacokinetic drug evaluation of ixazomib citrate for the treatment of multiple myeloma

References

• Kyle RA, Rajkumar SV. Multiple myeloma. Blood. 2008;111:2962–2972.
   PubMed Web of Science ®Google Scholar
• Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011;364:1046–1060.
   PubMed Web of Science ®Google Scholar
• National Cancer Institute [USA]. SEER Cancer Stat Facts: Myeloma. (Bethesda, MD): National Cancer Institute; 2017 [cited 2007 Jul 20]. Available from: https://seer.cancer.gov/statfacts/html/mulmy.html.
   Google Scholar
• Rajkumar SV. Multiple myeloma: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91:719–734.
   PubMed Web of Science ®Google Scholar
• Genadieva Stavric S, Bonello F, Bringhen S, et al. How is patient care for multiple myeloma advancing? Expert Rev Hematol. 2017;10:551–561.
   PubMed Web of Science ®Google Scholar
• VELCADE™ (bortezomib) for injection. Prescribing information. Cambridge (MA): Millennium Pharmaceuticals; 2003 [cited 2007 Jul 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021602s015lbl.pdf.
   Google Scholar
• Moreau P, Coiteux V, Hulin C, et al. Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma. Haematologica. 2008;93:1908–1911.
   PubMed Web of Science ®Google Scholar
• Moreau P, Pylypenko H, Grosicki S, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011;12:431–440.
   PubMed Web of Science ®Google Scholar
• KYPROLIS® (carfilzomib) for injection, for intravenous use. Full prescribing information. Thousand Oaks (CA): Onyx Pharmaceuticals; 2015 [cited 2007 Jul 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s009lbl.pdf.
   Google Scholar
• Moreau P. Oral therapy for multiple myeloma: ixazomib arriving soon. Blood. 2014;124:986–987.
   PubMed Web of Science ®Google Scholar
• Buac D, Shen M, Schmitt S, et al. From bortezomib to other inhibitors of the proteasome and beyond. Curr Pharm Des. 2013;19:4025–4038.
   PubMed Web of Science ®Google Scholar
• Muz B, Ghazarian RN, Ou M, et al. Spotlight on ixazomib: potential in the treatment of multiple myeloma. Drug Des Devel Ther. 2016;10:217–226.
   PubMed Web of Science ®Google Scholar
• Kupperman E, Lee EC, Cao Y, et al. Evaluation of the proteasome inhibitor MLN9708 in preclinical models of human cancer. Cancer Res. 2010;70:1970–1980.
   PubMed Web of Science ®Google Scholar
• NINLARO® (ixazomib) capsules. For oral use. Full prescribing information. Cambridge (MA): Takeda Pharmaceutical Company Limited; 2015 [cited 2007 Jul 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf.
   Google Scholar
• Assouline SE, Chang J, Cheson BD, et al. Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma. Blood Cancer J. 2014;4:e251.
   PubMed Web of Science ®Google Scholar
• Glickman MH, Ciechanover A. The ubiquitin-proteasome proteolytic pathway: destruction for the sake of construction. Physiol Rev. 2002;82:373–428.
   PubMed Web of Science ®Google Scholar
• Chauhan D, Tian Z, Zhou B, et al. In vitro and in vivo selective antitumor activity of a novel orally bioavailable proteasome inhibitor MLN9708 against multiple myeloma cells. Clin Cancer Res. 2011;17:5311–5321.
   PubMed Web of Science ®Google Scholar
• Garcia-Gomez A, Quwaider D, Canavese M, et al. Preclinical activity of the oral proteasome inhibitor MLN9708 in myeloma bone disease. Clin Cancer Res. 2014;20:1542–1554.
   PubMed Web of Science ®Google Scholar
• Gentile M, Offidani M, Vigna E, et al. Ixazomib for the treatment of multiple myeloma. Expert Opin Investig Drugs. 2015;24:1287–1298.
   PubMed Web of Science ®Google Scholar
• Accardi F, Toscani D, Bolzoni M, et al. Mechanism of action of bortezomib and the new proteasome inhibitors on myeloma cells and the bone microenvironment: impact on myeloma-induced alterations of bone remodeling. Biomed Res Int. 2015;2015:172458.
   PubMed Web of Science ®Google Scholar
• Gupta N, Liu G, Berg D, et al. Clinical pharmacokinetics of intravenous and oral MLN9708, an investigational proteasome inhibitor: an analysis of data from four phase 1 monotherapy studies. Blood. 2015; 116(21): abstract 1813.
   Google Scholar
• European Medicines Agency - Committee for Medicinal Products for Human Use. Assessment Report. Ninlaro®[INN: ixazomib]. London: European Medicines Agency; 2016 [cited 2007 Jul 20]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003844/WC500217623.pdf.
   Google Scholar
• Gupta N, Hanley MJ, Venkatakrishnan K, et al. The effect of a high-fat meal on the pharmacokinetics of ixazomib, an oral proteasome inhibitor, in patients with advanced solid tumors or lymphoma. J Clin Pharmacol. 2016;56:1288–1295.
   PubMed Web of Science ®Google Scholar
• Gupta N, Diderichsen PM, Hanley MJ, et al. Population pharmacokinetic analysis of ixazomib, an oral proteasome inhibitor, including data from the phase III TOURMALINE-MM1 study to inform labelling. Clin Pharmacokinet. 2017;56(11):1355–1368.
   Web of Science ®Google Scholar
• Gupta N, Zhao Y, Hui A-M, et al. Switching from body surface area-based to fixed dosing for the investigational proteasome inhibitor ixazomib: a population pharmacokinetic analysis. Br J Clin Pharmacol. 2015;79:789–800.
   PubMed Web of Science ®Google Scholar
• Gupta N, Hanley MJ, Venkatakrishnan K, et al. Pharmacokinetics of ixazomib, an oral proteasome inhibitor, in solid tumour patients with moderate or severe hepatic impairment. Br J Clin Pharmacol. 2016;82:728–738.
   PubMed Web of Science ®Google Scholar
• Dimopoulos MA, Terpos E, Chanan-Khan A, et al. Renal impairment in patients with multiple myeloma: a consensus statement on behalf of the International Myeloma Working Group. J Clin Oncol. 2010;28:4976–4984.
   PubMed Web of Science ®Google Scholar
• Gupta N, Hanley MJ, Harvey RD, et al. 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. Br J Haematol. 2016;174:748–759.
   PubMed Web of Science ®Google Scholar
• Richardson PG, Baz R, Wang M, et al. Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients. Blood. 2014;124:1038–1046.
   PubMed Web of Science ®Google Scholar
• Kumar SK, Bensinger WI, Zimmerman TM, et al. Phase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma. Blood. 2014;124:1047–1055.
   PubMed Web of Science ®Google Scholar
• Kumar SK, LaPlant B, Roy V, et al. Phase 2 trial of ixazomib in patients with relapsed multiple myeloma not refractory to bortezomib. Blood Cancer J. 2015;5:e338.
   PubMed Web of Science ®Google Scholar
• Kumar SK, Laplant BR, Reeder CB, et al. Randomized phase 2 trial of two different doses of ixazomib in patients with relapsed multiple myeloma not refractory to bortezomib. Blood. 2015;126:653. abstr 3050.
   Web of Science ®Google Scholar
• Moreau P, Masszi T, Grzasko N, et al. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374:1621–1634.
   PubMed Web of Science ®Google Scholar
• Kumar SK, Berdeja JG, Niesvizky R, et al. Safety and tolerability of ixazomib, an oral proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with previously untreated multiple myeloma: an open-label phase 1/2 study. Lancet Oncol. 2014;15:1503–1512.
   PubMed Web of Science ®Google Scholar
• Moreau P, Hulin C, Caillot D, et al. Ixazomib-lenalidomide-dexamethasone (IRd) combination before and after autologous stem cell transplantation (ASCT) followed by ixazomib maintenance in patients with newly diagnosed multiple myeloma (NDMM): a phase 2 study from the Intergroupe francophone du myélome (IFM). Blood. 2016;128(22): abstract 674.
   Google Scholar
• Kumar S, Berdeja JG, Niesvizky R, et al. Long-term ixazomib maintenance is tolerable and improves depth of response following ixazomib-lenalidomide-dexamethasone induction in patients (Pts) with previously untreated multiple myeloma (MM): phase 2 study results. Blood. 2014;124(21): abstract 82.
   Google Scholar
• Shah JJ, Feng L, Weber D, et al. Phase II study of the combination of ixazomib with lenalidomide as maintenance therapy following autologous stem cell transplant in patients with multiple myeloma. Blood. 2015;126(23): abstract 3155.
   Google Scholar
• Palumbo A, Morgan G, Rajkumar S, et al. Two phase 3 studies of the oral proteasome inhibitor (PI) ixazomib for multiple myeloma (MM) in the maintenance setting: TOURMALINE-MM3, and-MM4. J Clin Oncol. 2016;34(15_suppl): [published online before print].
   Web of Science ®Google Scholar
• Finnes H, Kumar S, LaPlant B, et al. Importance of pharmacovigilance in the era of small molecules: role of pharmacist consultation with ixazomib (IXA) in multiple myeloma (MM). J Clin Oncol. 2016;34:8058.
   Web of Science ®Google Scholar
• Assouline S, Chang JE, Cheson BD, et al. Results of a phase 1 dose-escalation study of once-weekly MLN9708, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma. Blood. 2015;120(21): abstract 3646.
   Web of Science ®Google Scholar
• Rodler ET, Infante JR, Siu LL, et al. First-in-human, phase I dose-escalation study of investigational drug MLN9708, a second-generation proteasome inhibitor, in advanced nonhematologic malignancies. J Clin Oncol. 2010;28:3071.
   Web of Science ®Google Scholar
• European Medicines Agency. Positive opinion on the marketing authorisation for Ninlaro® (ixaxomib). Outcome of re-examination. London: European Medicines Agency; 2016 [cited 2007 Jul 20]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2016/09/WC500212895.pdf.
   Google Scholar
• Morawska M, Grzasko N, Kostyra M, et al. Therapy-related peripheral neuropathy in multiple myeloma patients. Hematol Oncol. 2015;33:113–119.
   PubMed Web of Science ®Google Scholar
• Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016;17:27–38.
   PubMed Web of Science ®Google Scholar
• Stewart AK, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372:142–152.
   PubMed Web of Science ®Google Scholar
• Avet-Loiseau H, Bahlis NJ, Chng W-J, et al. Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients. Blood. 2017. blood-2017-06-791228
   Google Scholar
• Richardson PG, Kumar S, Laubach JP, et al. New developments in the management of relapsed/refractory multiple myeloma - the role of ixazomib. J Blood Med. 2017;8:107–121.
   PubMed Web of Science ®Google Scholar
• Mateos M-V, Masszi T, Grzasko N, et al. 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. Haematologica. 2017;102:1767–1775.
   PubMed Web of Science ®Google Scholar
• Ludwig H, Poenisch W, Knop S, et al. All oral combination of ixazomib plus thalidomide and dexamethasone for relapsed or refractory multiple myeloma: interim data of an ongoing phase II trial. Haematologica. 2017;102(s2): 110 [abstract P336].
   Google Scholar
• Reu FJ, Valent J, Malek E, et al. A phase I study of ixazomib in combination with panobinostat and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2015;126:4221.
   Web of Science ®Google Scholar
• ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29 – present. Identifier NCT02831686, A study to test the combination of selinexor (KPT-330), ixazomib, and dexamethasone in patients with myeloma; 2016 Jul 13 [cited 2017 Jul 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT02831686?term=ixazomib&rank=49.
   Google Scholar
• Voorhees PM, Mulkey F, Hassoun H, et al. Alliance A061202. a phase i/ii study of pomalidomide, dexamethasone and ixazomib versus pomalidomide and dexamethasone for patients with multiple myeloma refractory to lenalidomide and proteasome inhibitor based therapy: phase i results. Blood. 2015;126(23): abstract 375.
   Google Scholar
• ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29 - present. Identifier NCT03012880, Ixazomib citrate, lenalidomide, dexamethasone, and daratumumab in treating patients with newly diagnosed multiple myeloma; 2017 Jan 06 [cited 2017 Jul 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT03012880.
   Google Scholar
• ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29 - present. Identifier NCT01335685, Study of oral IXAZOMIB in combination with melphalan and prednisone in patients with newly diagnosed multiple myeloma; 2011 Apr 14 – 2017 Feb 23 [cited 2017 Jul 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT01335685.
   Google Scholar
• San Miguel J, Gutierrez MAE, Špicka I, et al. The oral proteasome inhibitor ixazomib in combination with melphalan-prednisone (MP) for Patients (pts) with newly diagnosed multiple myeloma (NDMM): phase 1/2 dose-escalation study (nct01335685). Haematologica. 2017;102(s2):111–112 [abstract P339].
   Google Scholar
• Dimopoulos MA, Grosicki S, Jędrzejczak W, et al. An open-label, phase 2 study to evaluate the oral combination of ixazomib, cyclophosphamide and dexamethasone (icd) in transplant-ineligible patients (PTS) with newly diagnosed multiple myeloma (NDMM). Haematologica. 2017;102(s2):111 [abstract P338].
   Google Scholar
• Krishnan AY, Kapoor P, Palmer J, et al. A phase I/II study of ixazomib (Ix) pomalidomide (POM) dexamethasone (DEX) in relapsed refractory (R/R) multiple myeloma: initial results. | 2016 ASCO annual meeting | abstracts | meeting library. J Clin Oncol. 2016:34(15_suppl): abstract 8008.
   Google Scholar
• Musto P, Montefusco V. Are maintenance and continuous therapies indicated for every patient with multiple myeloma? Expert Rev Hematol. 2016;9:743–751.
   PubMed Web of Science ®Google Scholar
• Rajkumar SV The ENDEAVOR trial: a case study in the interpretation of modern cancer trials [Internet]. ASCO Post. 2016 [cited 2017 Nov 8]. Available from: http://www.ascopost.com/issues/june-10-2016/the-endeavor-trial-a-case-study-in-the-interpretation-of-modern-cancer-trials/
   Google Scholar
• Rajkumar SV, Harousseau JL. Next-generation multiple myeloma treatment: a pharmacoeconomic perspective. Blood. 2016;128:2757–2764.
   PubMed Web of Science ®Google Scholar
• Chen Y, Lairson DR, Chan W, et al. Cost-effectiveness of novel agents in medicare patients with multiple myeloma: findings from a U.S. payer’s perspective. J Manag Care Spec Pharm. 2017;23:831–843.
   PubMedGoogle Scholar