472
Views
9
CrossRef citations to date
0
Altmetric
Drug Evaluation

Sorafenib for the treatment of multiple myeloma

, , , , &
Pages 743-749 | Received 19 Jan 2016, Accepted 18 Mar 2016, Published online: 06 Apr 2016

References

  • San Miguel J. Multiple myeloma: a model for scientific and clinical progress. Hematology Am Soc Hematol Educ Program. 2014;2014:1–7.
  • National Cancer Institute. Surveillance epidemiology and end results program. SEER stat fact sheets on multiple myeloma. 2013 [cited 2013 Apr 24]. Available from: http://seer.cancer.gov/statfacts/html/mulmy.html
  • Andrews SW, Kabrah S, May JE, et al. Multiple myeloma: the bone marrow microenvironment and its relation to treatment. Br J Biomed Sci. 2013;70:110–120.
  • Richardson PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005;352:2487–2498.
  • Singhal S, Mehta J, Desikan R, et al. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999;341:1565–1571.
  • Rajkumar SV, Hayman SR, Lacy MQ, et al. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood. 2005;106:4050–4053.
  • Richardson PG, Blood E, Mitsiades CS, et al. A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood. 2006;108:3458–3464.
  • Röllig C, Knop S, Bornhäuser M. Multiple myeloma. Lancet. 2015;385:2197–2208.
  • Morgan GJ, Davies FE, Gregory WM, et al. First-line and ongoing treatment with zoledronic acid improves overall survival in patients with multiple myeloma: results of the MRC IX randomised controlled trial. Lancet. 2010;376:1989–1999.
  • Mikhael JR, Dingli D, Roy V, et al. Management of newly diagnosed symptomatic multiple myeloma: updated mayo stratification of myeloma and risk-adapted therapy (mSMART) consensus guidelines 2013. Mayo Clin Proc. 2013;88:360–376.
  • Rajkumar SV. Myeloma today: disease definitions and treatment advances. Am J Hematol. 2015 Nov 13. doi:10.1002/ajh.24236. [Epub ahead of print].
  • Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149–157.
  • San Miguel J, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14:1055–1066.
  • Lacy MQ, Hayman SR, Gertz MA, et al. Pomalidomide (CC4047) plus low dose dexamethasone (Pom/dex) is active and well tolerated in lenalidomide refractory multiple myeloma (MM). Leukemia. 2010;24:1934–1939.
  • Shah JJ, Stadtmauer EA, Abonour R, et al. Phase I/II dose expansion of a multi-center trial of carfilzomib and pomalidomide with dexamethasone (Car-Pom-d) in patients with relapsed/refractory multiple myeloma. Blood. 2013;122:690.
  • Larocca A, Montefusco V, Bringhen S, et al. Pomalidomide, cyclophosphamide, and prednisone for relapsed/refractory multiple myeloma: a multicenter phase 1/2 open-label study. Blood. 2013;122:2799–2806.
  • Mark TM, Boyer A, Rossi AC, et al. Clapd (clarithromycin, pomalidomide, dexamethasone) therapy in relapsed or refractory multiple myeloma. Blood (ASH Annual Meeting). 2013;122:1955.
  • Vij R, Siegel DS, Jagannath S, et al. An open label, single-arm, phase 2 study of single-agent carfilzomib in patients with relapsed and/or refractory multiple myeloma who have been previously treated with bortezomib. Br J Haematol. 2012;158:739–748.
  • Siegel D, Martin T, Nooka A, et al. Integrated safety profile of single-agent carfilzomib: experience from 526 patients enrolled in 4 phase II clinical studies. Haematologica. 2013;98:1753–1761.
  • Kaufman J, Zimmerman T, Jakubowiak A, et al. Phase I study of combination of carfilzomib and panabinostat for patients with relapsed and refractory myeloma: a multicenter MMRC clinical trial. Haematologica (EHA Annual Meeting). 2013;98(suppl 1):322.
  • Shah JJ, Weber DM, Thomas SK, et al. Phase 1 study of the novel kinesin spindle protein inhibitor ARRY-520 1 carfilzomib in patients with relapsed and/or refractory multiple myeloma. Blood. 2012;120:4082.
  • Vesole DH, Siegel DSD, Richter JR, et al. A phase I study of carfilzomib, lenalidomide, vorinostat, and dexamethasone (QUAD) in relapsed and/or refractory multiple myeloma (MM). J Clin Oncol (ASCO Annual Meeting). 2014;32:8535.
  • Bringhen S, Petrucci MT, Larocca A, et al. Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: a multicenter, phase 2 study. Blood. 2014;124:63–69.
  • Shah JJ, Stadtmauer EA, Abonour R, et al. Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma. Blood. 2015;126:2284–2290.
  • Hideshima T, Bradner JE, Wong J, et al. Small-molecule inhibition of proteasome and aggresome function induces synergistic antitumor activity in multiple myeloma. Proc Natl Acad Sci U S A. 2005;102:8567–8572.
  • San-Miguel JF, Richardson PG, Gunther A, et al. Phase Ib study of panobinostat and bortezomib in relapsed or relapsed and refractory multiple myeloma. J Clin Oncol. 2013;31:3696–3703.
  • San-Miguel JF, Hungria VTM, Yoon S. Randomized phase 3 trial of the deacetylase inhibitor panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in relapsed or relapsed and refractory multiple myeloma. Lancet Oncol. 2014;15:1195–1206.
  • Lonial S, Vij R, Harousseau JL, et al. Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma. J Clin Oncol. 2012;30:1953–1959.
  • Jakubowiak AJ, Benson DM, Bensinger W, et al. Phase I trial of anti-CS1 monoclonal antibody elotuzumab in combination with bortezomib in the treatment of relapsed/refractory multiple myeloma. J Clin Oncol. 2012;30:1960–1965.
  • Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373:621–631.
  • Lonial S, Weiss BM, Usmani SZ, et al. Phase II study of daratumumab (DARA) monotherapy in patients with ≥ 3 lines of prior therapy or double refractory multiple myeloma (MM): MMY2002 (Sirius). J Clin Oncol (ASCO Annual Meeting). 2015;33:LBA8512.
  • Plesner T, Arkenau T, Lokhorst H, et al. Preliminary safety and efficacy data of daratumumab in combination with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma. Blood (ASH Annual Meeting). 2014;124:184.
  • Gentile M, Offidani M, Vigna E, et al. Ixazomib for the treatment of multiple myeloma. Expert Opin Investig Drugs. 2015;24:1287–1298.
  • 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 (NCT01564537). Blood (ASH Annual Meeting). 2015;125:727.
  • Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004;64:7099–7109.
  • Yu C, Rahmani M, Almenara J, et al. Induction of apoptosis in human leukemia cells by the tyrosine kinase inhibitor adaphostin proceeds through a RAF-1/MEK/ERK- and AKT-dependent process. Oncogene. 2004;23:1364–1376.
  • Panka DJ, Wang W, Atkins MB, et al. The Raf inhibitor BAY 43-9006 (Sorafenib) induces caspase-independent apoptosis in melanoma cells. Cancer Res. 2006;66:1611–1619.
  • Rahmani M, Davis EM, Bauer C, et al. Apoptosis induced by the kinase inhibitor BAY 43-9006 in human leukemia cells involves down-regulation of Mcl-1 through inhibition of translation. J Biol Chem. 2005;280:35217–35227.
  • Wan PT, Garnett MJ, Roe SM, et al. Mechanism of activation of the RAF-ERK signaling pathway by oncogenic mutations of B-RAF. Cell. 2004;116:855–867.
  • Carlomagno F, Anaganti S, Guida T, et al. BAY 43-9006 inhibition of oncogenic RET mutants. J Natl Cancer Inst. 2006;98:326–334.
  • Agency EMA. Sorafenib (Nexavar): summary of product characteristics (online). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000690/WC500027704.pdf
  • Yordanova A, Hose D, Neben K, et al. Sorafenib in patients with refractory or recurrent multiple myeloma. Hematol Oncol. 2013;31:197–200.
  • Srkalovic G, Hussein MA, Hoering A, et al. A phase II trial of BAY 43-9006 (sorafenib) (NSC-724772) in patients with relapsing and resistant multiple myeloma: SWOG S0434. Cancer Med. 2014;3:1275–1283.
  • Flaherty KT, Redlinger M, Schuchter LM, et al. Phase I/II, pharmacokinetic and pharmacodynamics trial of BAY 43-9006 alone in patients with metastatic melanoma. J Clin Oncol. 2005;23(16S):3037.
  • Rini BI. Sorafenib. Expert Opin Pharmacother. 2006;7:453–461.
  • Lathia C, Lettieri J, Cihon F, et al. Lack of effect of ketoconazole-mediated CYP3A inhibition on sorafenib clinical pharmacokinetics. Cancer Chemother Pharmacol. 2006;57:685–692.
  • Hideshima T, Anderson KC. Novel therapies in MM: from the aspect of preclinical studies. Int J Hematol. 2011;94:344–354.
  • Ramakrishnan V, Timm M, Haug JL, et al. Sorafenib, a dual Raf kinase/vascular endothelial growth factor receptor inhibitor has significant anti-myeloma activity and synergizes with common anti-myeloma drugs. Oncogene. 2010;29:1190–1202.
  • Chapman MA, Lawrence MS, Keats JJ, et al. Initial genome sequencing and analysis of multiple myeloma. Nature. 2011;471:467–472.
  • Chng WJ, Gonzalez-Paz N, Price-Troska T, et al. Clinical and biological significance of RAS mutations in multiple myeloma. Leukemia. 2008;22:2280–2284.
  • Bezieau S, Devilder MC, Avet-Loiseau H, et al. High incidence of N and K-Ras activating mutations in multiple myeloma and primary plasma cell leukemia at diagnosis. Hum Mutat. 2001;18:212–224.
  • Kharaziha P, De Raeve H, Fristedt C, et al. Sorafenib has potent antitumor activity against multiple myeloma in vitro, ex vivo, and in vivo in the 5T33MM mouse model. Cancer Res. 2012;72:5348–5362.
  • Udi J, Schüler J, Wider D, et al. Potent in vitro and in vivo activity of sorafenib in multiple myeloma: induction of cell death, CD138-downregulation and inhibition of migration through actin depolymerization. Br J Haematol. 2013;161:104–116.
  • Ramírez-Labrada A, López-Royuela N, Jarauta V, et al. Two death pathways induced by sorafenib in myeloma cells: Puma-mediated apoptosis and necroptosis. Clin Transl Oncol. 2015;17:121–132.
  • Kharaziha P, Ceder S, Sanchez C, et al. Multitargeted therapies for multiple myeloma. Autophagy. 2013;9:255–257.
  • Leow CCY, Gerondakis S, Spencer A. MEK inhibitors as a chemotherapeutic intervention in multiple myeloma. Blood Cancer J. 2013;3:e105.
  • Kumar SK, Jett J, Marks R, et al. Phase 1 study of sorafenib in combination with bortezomib in patients with advanced malignancies. Invest New Drugs. 2013;31:1201–1206.
  • Mangana J, Levesque MP, Karpova MB, et al. Sorafenib in melanoma. Expert Opin Investig Drugs. 2012;21:557–568.
  • Kumar S, Porrata LF, Ansell SM, et al. Phase 1 trial of sorafenib and everolimus in patients with lymphoma or multiple myeloma. Blood (ASH Annual Meeting). 2010;116:2802.
  • Mayo Clinic; University of Iowa. Sorafenib and everolimus in treating patients with relapsed or refractory lymphoma or multiple myeloma (NCT00474929). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited 2007 May 16]. Available from: https://clinicaltrials.gov/ct2/show/NCT00474929? term=sorafenib+myeloma&rank=1 Identifier: NCT00474929.
  • SCRI Development Innovations, LLC; Bayer. Sorafenib and bortezomib treatment for relapsed or refractory multiple myeloma patients (NCT00536575). Bethesda (MD): National Library of Medicine (US). 2000 [cited 2007 Sep 26]. Available from: https://clinicaltrials.gov/ct2/show/NCT00536575?term=sorafenib+myeloma&rank=2 Identifier: NCT00536575.
  • National Cancer Institute (NCI). Sorafenib in treating patients with relapsed or refractory multiple myeloma (NCT00253578). Bethesda (MD): National Library of Medicine (US). 2000 [cited 2005 Nov 11]. Available from: https://clinicaltrials.gov/ct2/show/NCT00253578?term=sorafenib+myeloma&rank=3 Identifier: NCT00253578.
  • Mayo Clinic; National Cancer Institute (NCI). Sorafenib, lenalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma (NCT00687674). Bethesda (MD): National Library of Medicine (US).. 2000 [cited 2008 May 30]. Available from: https://clinicaltrials.gov/ct2/show/NCT00687674?term=sorafenib+myeloma&rank=4 Identifier: NCT00687674.
  • National Cancer Institute (NCI). Sorafenib in treating patients with metastatic or unresectable solid tumors, multiple myeloma, or Non-Hodgkin’s lymphoma with or without impaired liver or kidney function (NCT00118170). Bethesda (MD): National Library of Medicine (US). 2000 [cited 2008 Jul 11]. Available from: https://clinicaltrials.gov/ct2/show/NCT00118170?term=sorafenib+myeloma&rank=5 Identifier: NCT00118170.
  • National Cancer Institute (NCI). Sorafenib and bortezomib in treating patients with advanced cancer (NCT00303797). Bethesda (MD): National Library of Medicine (US). 2000 [cited 2006 Mar 15]. Available from: https://clinicaltrials.gov/ct2/show/NCT00303797?term=sorafenib+myeloma&rank=6 Identifier: NCT00303797.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.