Ixazomib: an oral proteasome inhibitor for the treatment of multiple myeloma

Bibliography

• Siegel RL, Miller KD, Jemal A, et al. Cancer statistics, 2015. CA Cancer J Clin. 2015;65(1):5–29.
   PubMed Web of Science ®Google Scholar
• Moreau P, San Miguel J, Ludwig H, et al. Multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(Suppl 6):vi133–137.
   PubMed Web of Science ®Google Scholar
• Kumar SK, Rajkumar SV, Dispenzieri A, et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008;111(5):2516–2520.
   PubMed Web of Science ®Google Scholar
• Kumar SK, Dispenzieri A, Lacy MQ, et al. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014;28(5):1122–1128.
   PubMed Web of Science ®Google Scholar
• Richardson PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005;352(24):2487–2498.
   PubMed Web of Science ®Google Scholar
• Richardson PG, Sonneveld P, Schuster MW, et al. Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial. Blood. 2007;110(10):3557–3560.
   PubMed Web of Science ®Google Scholar
• Engelhardt M, Terpos E, Klerber M, et al. European Myeloma Network recommendations on the evaluation and treatment of newly diagnosed patients with multiple myeloma. Haematologica. 2014;99(2):232–242.
   PubMed Web of Science ®Google Scholar
• Neben K, Lokhorst HM, Jauch A, et al. Administration of bortezomib before and after autologous stem cell transplantation improves outcome in multiple myeloma patients with deletion 17p. Blood. 2012;119(4):940–948.
   PubMed Web of Science ®Google Scholar
• Palumbo A, Bringhen S, Larocca A, et al. Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival. J Clin Oncol. 2014;32(7):634–640.
   PubMed Web of Science ®Google Scholar
• Mateos MV, Oriol A, Martinez-Lopez J, et al. Maintenance therapy with bortezomib plus thalidomide or bortezomib plus prednisone in elderly multiple myeloma patients included in the GEM2005MAS65 trial. Blood. 2012;120(13):2581–2588.
   PubMed Web of Science ®Google Scholar
• Morabito F, Bringhen S, Larocca A, et al. Bortezomib, melphalan, prednisone (VMP) versus melphalan, prednisone, thalidomide (MPT) in elderly newly diagnosed multiple myeloma patients: A retrospective case-matched study. Am J Hematol. 2014;89(4):355–362.
   PubMed Web of Science ®Google Scholar
• Cavo M, Rajkumar SV, Palumbo A, et al. International Myeloma Working Group consensus approach to the treatment of multiple myeloma patients who are candidates for autologous stem cell transplantation. Blood. 2011;117(23):6063–6073.
   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(5):431–440.
   PubMed Web of Science ®Google Scholar
• Bringhen S, Larocca A, Rossi D, et al. Efficacy and safety of once-weekly bortezomib in multiple myeloma patients. Blood. 2010;116(23):4745–4753.
   PubMed Web of Science ®Google Scholar
• Siegel DS, Martin T, Wang M, et al. A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma. Blood. 2012;120(14):2817–2825.
   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(2):142–152.
   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(5):1970–1980.
   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(16):5311–5321.
   PubMed Web of Science ®Google Scholar
• Lee EC, Fitzgerald M, Bannerman B, et al. Antitumor activity of the investigational proteasome inhibitor MLN9708 in mouse models of B-cell and plasma cell malignancies. Clin Cancer Res. 2011;17(23):7313–7323.
   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(6):1542–1554.
   PubMed Web of Science ®Google Scholar
• Palani S, Bannerman B, Xia C, et al. Preclinical PK/efficacy relationships for MLN9708, an investigational small molecule proteasome inhibitor, in MM.1S human multiple myeloma xenografts. Haematologica. 2013;98(s1):406–407.
   Google Scholar
• Berger AJ, Bannerman B, Quayle SN, et al. Preclinical combination of the oral investigational agents ACY-1215, a selective HDAC6 inhibitor, and ixazomib, a proteasome inhibitor, demonstrates combination benefit in multiple myeloma cell lines and xenograft models. Blood. 2013;122(21):Abstract 4437.
   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(7):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(7):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;4:e338.
   Web of Science ®Google Scholar
• Kumar SK, Roy V, Reeder CB, et al. Phase II trial of single agent MLN9708 in patients with relapsed multiple myeloma not refractory to bortezomib. Blood. 2013;122(21):Abstract 1944.
   Google Scholar
• Gupta N, Goh YT, Min CK, et al. Phase I pharmakokinetic (PK) study of ixazomib citrate (MLN9708) plus lenalidomide and dexamethasone in Asian patients with relapse/refractory multiple myeloma. Haematologica. 2014;99(si)(372):Abstract P981.
   Google Scholar
• Moreau P, Masszi T, Grzasko N, et al. Ixazomib, an investigational oral proteasome inhibitor (PI), in combination with lenalidomide and dexamethasone (IRd), significantly extends progression-free survival (PFS) for patients (Pts) with relapsed and/or refractory multiple myeloma (RRMM): the Phase 3 tourmaline-MM1 Study (NCT 01564537). Blood [Internet]. 2015 [cited 2015 Nov 17];126:abstract 727. Available from: https://ash.confex.com/ash/2015/webprogram/Paper79829.html
   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(13):1503–1512.
   PubMed Web of Science ®Google Scholar
• Richardson PG, Hofmeister CC, Rosenbaum CA, et al. Twice-weekly oral MLN9708 (ixazomib citrate), an investigational proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma: final phase I results and phase 2 data. Blood. 2013;122(21):Abstract 535.
   Google Scholar
• Richardson P, Berdeja J, Niesvizky R, et al. Weekly oral investigational proteasome inhibitor MLN9708 plus lenalidomide-dexamethasone in elderly patients with previously untreated multiple myeloma: subset analysis of a phase 1/2 study. Haematologica. 2013;98(s1)(102):Abstract P236.
   Google Scholar
• Richardson P, Rosenbaum CA, Hofmeister CC, et al. Oral investigational proteasome inhibitor ixazomib citrate (MLN9708) plus lenalidomide-dexamethasone in elderly patients with previously untreated multiple myeloma. Haematologica. 2014;99(S1)(106):Abstract P355.
   Google Scholar
• San Miguel J, Hajek R, Spicka I, et al. Oral MLN9708, an investigational proteasome inhibitor, in combination with melphalan and prednisone in patients with previously untreated multiple myeloma: a phase 1 study. EHA. 2012;2012:Abstarct 0293.
   Google Scholar
• Kumar SK, Berdeja JG, Niesvizky R, et al. Long- term ixazomib maintenance is tolerable and improves depth of response following ixazomib-lenalidomide-dexamethasone induction in patients with previously untreated multiple myeloma (MM): phase 2 study results. Blood. 2014;124(21):82–83.
   Google Scholar
• Shah JJ, Baladandayuthapani V, Weber DM, et al. Phase II study of the combination of MLN 9708 with lenalidomide as maintenance therapy post autologous stem cell transplant in patients with multiple myeloma. Blood. 2013;122(21):1983–1983.
   PubMed Web of Science ®Google Scholar