Phase II study of melphalan, thalidomide and prednisone combined with oral panobinostat in patients with relapsed/refractory multiple myeloma

References

• Kapoor P, Rajkumar SV, Dispenzieri A, . Melphalan and prednisone versus melphalan, prednisone and thalidomide for elderly and/or transplant ineligible patients with multiple myeloma: a meta-analysis. Leukemia 2011;25:689–696.
   PubMed Web of Science ®Google Scholar
• San Miguel JF, Schlag R, Khuageva NK, . Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med 2008;359:906–917.
   PubMed Web of Science ®Google Scholar
• Rajkumar SV, Jacobus S, Callander NS, . Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open label randomised controlled trial. Lancet Oncol 2010;11:29–37.
   PubMed Web of Science ®Google Scholar
• Palumbo A, Avonto I, Bruno B, . Intravenous melphalan, thalidomide and prednisone in refractory and relapsed multiple myeloma. Eur J Haematol 2006;76:273–277.
   PubMed Web of Science ®Google Scholar
• Lane A, Chabner BA. Histone deacetylase inhibitors in cancer therapy. J Clin Oncol 2009;27:5459–5468.
   PubMed Web of Science ®Google Scholar
• Cameron EE, Bachman KE, Myohanen S, Myöhänen S, Herman JG, Baylin SB. Synergy of demethylation and histone deacetylase inhibition in the re-expression of genes silenced in cancer. Nat Genet 1999;2:103–107.
   Web of Science ®Google Scholar
• Medina V, Edmonds B, Young GP, . Induction of caspase-3 protease activity and apoptosis by butyrate and trichostatin A (inhibitors of histone deacetylase): dependence on protein synthesis and synergy with a mitochondrial/cytochrome c-dependent pathway. Cancer Res 1997;57:3697–3707.
   PubMed Web of Science ®Google Scholar
• Catley L, Weisberg E, Kiziltepe T, . Aggresome induction by proteasome inhibitor bortezomib and alpha-tubulin hyperacetylation by tubulin deacetylase (TDAC) inhibitor LBH589 are synergistic in myeloma cells. Blood 2006;108:3441–3449.
   PubMed Web of Science ®Google Scholar
• Maiso P, Carvajal-Vergara X, Ocio EM, . The histone deacetylase inhibitor LBH589 is a potent antimyeloma agent that overcomes drug resistance. Cancer Res 2006;15:5250–5257.
   Google Scholar
• Ocio EM, Vilanova D, Atadja P, . In vitro and in vivo rationale for the triple combination of panobinostat (LBH589) and dexamethasone with either bortezomib or lenalidomide in multiple myeloma. Haematologica 2010;95:794–803.
   PubMed Web of Science ®Google Scholar
• Sanchez E, Shen J, Steinberg J, . The histone deacetylase inhibitor LBH589 enhances the anti-myeloma effects of chemotherapy in vitro and in vivo. Leuk Res 2011;35:373–379.
   PubMed Web of Science ®Google Scholar
• Prince HM, George D, Patnaik A, . Phase I study of oral LBH589, a novel deacetylase (DAC) inhibitor in advanced solid tumors and non-Hodgkin's lymphoma. J Clin Oncol 2007;25(18 Suppl.): Abstract 3500.
   PubMed Web of Science ®Google Scholar
• Duvic M, Becker JC, Dalle S, . Phase II trial of oral panobinostat (LBH589) in patients with refractory cutaneous T-cell lymphoma (CTCL). Blood 2008;112(Suppl. 1): Abstract 1005.
   PubMed Web of Science ®Google Scholar
• Sureda A, Younes A, Ben-Yehuda D, . Final analysis: phase II study of oral panobinostat in relapsed/refractory Hodgkin lymphoma patients following autologous hematopoietic stem cell transplant. Blood 2010;116 (Suppl. 1): Abstract 419.
   Google Scholar
• Ottmann OG, Spencer A, Prince HM, . Phase IA/II study of oral panobinostat (LBH589), a novel pan-deacetylase inhibitor (DACi) demonstrating efficacy in patients with advanced hematologic malignancies. Blood 2008;112(Suppl. 1): Abstract 1005.
   Google Scholar
• Wolf JL, Siegel D, Matous J, . A phase II study of oral panobinostat (LBH589) in adult patients with advanced refractory multiple myeloma. Blood 2008;112(Suppl. 1): Abstract 2774.
   PubMed Web of Science ®Google Scholar
• Bryant J, Day R. Incorporating toxicity considerations into the design of two-stage phase II clinical trials. Biometrics 1995;51: 1372–1383.
   PubMed Web of Science ®Google Scholar
• Durie B, Harousseau J-L, San Miguel JS, . International uniform response criteria for multiple myeloma. Leukemia 2006;20:1467–1473.
   PubMed Web of Science ®Google Scholar
• Mateos M, Spencer A, Taylor K, . Phase Ib study of oral panobinostat (LBH589) plus lenaldomide (LEN) plus dexamethasone (DEX) in patients with relapsed (Rel) and refractory (Ref) multiple myeloma (MM). J Clin Oncol 2010;28(15 Suppl.): Abstract 8030.
   PubMed Web of Science ®Google Scholar
• San Miguel JF, Sezer O, Siegel DS, . Phase Ib study of oral panobinostat (LBH589) plus intravenous bortezomib in patients with relapsed (Rel) or refractory (Ref) multiple myeloma (MM). J Clin Oncol 2010;28(15 Suppl.): Abstract 8001.
   Web of Science ®Google Scholar
• Berenson J, Yellin O, Kazamel T, . A phase I/II study of oral melphalan (Mel) combined with panobinostat (Pan) for patients with relapsed or refractory multiple myeloma. Haematologica 2011;96(Suppl. 1):P-206.
   Google Scholar
• Giver CR, Jaye DL, Waller EK, . Rapid recovery from panobinostat (LBH589)-induced thrombocytopenia in mice involves a rebound effect of bone marrow megakaryocytes. Leukemia 2011;25:362–365.
   PubMed Web of Science ®Google Scholar
• Bishton MJ, Harrison SJ, Martin BP, . Deciphering the molecular and biologic processes that mediate histone deacetylase inhibitor-induced thrombocytopenia. Blood 2011;117:3658–3668.
   PubMed Web of Science ®Google Scholar
• Schlossman R, Alsina M, Weber D, . Panorama 2: a phase II study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma. Haematologica 2011;96 (Suppl. 2): Abstract 0900.
   Google Scholar
• Jones PA, Baylin SB. The epigenomics of cancer. Cell 2007;128: 683–692.
   PubMed Web of Science ®Google Scholar