Therapeutic use of immunomodulatory drugs in the treatment of multiple myeloma

References

• Hideshima T, Bergsagel PL, Kuehl WM, Anderson KC. Advances in biology of multiple myeloma: clinical applications. Blood104, 607–618 (2004).
   PubMed Web of Science ®Google Scholar
• Rajkumar SV, Kyle RA. Multiple myeloma: diagnosis and treatment. Mayo Clin. Proc.80(10), 1371–1382 (2005).
   PubMed Web of Science ®Google Scholar
• Jemal A, Siegel R, Ward E et al. Cancer statistics, 2006. CA Cancer J. Clin.56(2), 106–130 (2006).
   PubMed Web of Science ®Google Scholar
• Hideshima T, Chauhan D, Richardson P, Anderson KC. Identification and validation of novel therapeutic targets for multiple myeloma. J. Clin. Oncol.23(26), 6345–6350 (2005).
   PubMed Web of Science ®Google Scholar
• Tseng S, Pak G, Washenik K, Pomeranz MK, Shupack JL. Rediscovering thalidomide: a review of its mechanism of action, side effects, and potential uses. J. Am. Acad. Dermatol.35, 969–979 (1996).
   PubMed Web of Science ®Google Scholar
• Muller GW, Corral LG, Shire MG et al. Structural modifications of thalidomide produce analogs with enhanced tumor necrosis factor inhibitory activity. J. Med. Chem.39, 3238–3240 (1996).
   PubMed Web of Science ®Google Scholar
• Blaschke G, Kraft HP, Fickentscher K, Kohler F. Chromatographic separation of racemic thalidomide and teratogenic activity of its enantiomers (author’s transl.). Arzneimittelforschung29(10), 1640–1642 (1979).
   PubMed Web of Science ®Google Scholar
• Reist M, Carrupt PA, Francotte E, Testa B. Chiral inversion and hydrolysis of thalidomide: mechanisms and catalysis by bases and serum albumin, and chiral stability of teratogenic metabolites. Chem. Res. Toxicol.11, 1521–1528 (1998).
   PubMed Web of Science ®Google Scholar
• Fabro S, Smith RL, Williams RT. Toxicity and teratogenicity of optical isomers of thalidomide. Nature215(98), 296 (1967).
   PubMed Web of Science ®Google Scholar
• Nishimura K, Hashimoto Y, Iwasaki S. (S)-form of α-methyl-N(α)-phthalimidoglutarimide, but not its (R)-form, enhanced phorbol ester-induced tumor necrosis factor-α production by human leukemia cell HL-60: implication of optical resolution of thalidomidal effects. Chem. Pharm. Bull. (Tokyo)42(5), 1157–1159 (1994).
   PubMed Web of Science ®Google Scholar
• Corral LG, Haslett PAJ, Muller GW et al. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-α. J. Immunol.163, 380–386 (1999).
   PubMed Web of Science ®Google Scholar
• Chung F, Lu J, Palmer BD et al. Thalidomide pharmacokinetics and metabolite formation in mice, rabbits, and multiple myeloma patients. Clin. Cancer Res.10(17), 5949–5956 (2004).
   PubMed Web of Science ®Google Scholar
• Wu A, Scheffler MR. Multi-dose phamacokinetics and safety of CC-5013 in 15 multiple myeloma patients. J. Clin. Oncol.22, 141S (2004).
   Web of Science ®Google Scholar
• Hideshima T, Chauhan D, Shima Y et al. Thalidomide and its analogues overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood96, 2943–2950 (2000).
   PubMed Web of Science ®Google Scholar
• Mitsiades N, Mitsiades CS, Poulaki V et al. Apoptotic signaling induced by immunomodulatory thalidomide analogs in human multiple myeloma cells: therapeutic implications. Blood99(12), 4525–4530 (2002).
   PubMed Web of Science ®Google Scholar
• Fujita E, Jinbo A, Matuzaki H, Konishi H, Kikkawa U, Momoi T. Akt phosphorylation site found in human caspase-9 is absent in mouse caspase-9. Biochem. Biophys. Res. Commun.264, 550–555 (1999).
   PubMed Web of Science ®Google Scholar
• Hideshima T, Chauhan D, Richardson P et al. NF-κB as a therapeutic target in multiple myeloma. J. Biol. Chem.277(19), 16639–16647 (2002).
   PubMed Web of Science ®Google Scholar
• Hideshima T, Anderson KC. Molecular mechanisms of novel therapeutic approaches for multiple myeloma. Nat. Rev. Cancer2, 927–937 (2002).
   PubMed Web of Science ®Google Scholar
• Chauhan D, Uchiyama H, Akbarali Y et al. Multiple myeloma cell adhesion-induced interleukin-6 expression in bone marrow stromal cells involves activation of NF-κB. Blood87, 1104–1112 (1996).
   PubMed Web of Science ®Google Scholar
• Stewart AK, Scanga SE, Zhu YX, Yahyapour M, Manoukian A. Inhibition of Wnt pathway signaling by thalidomide and revlimid: studies in a Drosophila model system. Blood104, 916A (2004).
   Google Scholar
• Hideshima T, Nakamura N, Chauhan D, Anderson KC. Biologic sequelae of interleukin-6 induced PI3-K/Akt signaling in multiple myeloma. Oncogene20, 5991–6000 (2001).
   PubMed Web of Science ®Google Scholar
• Chauhan D, Hideshima T, Rosen S, Reed JC, Kharbanda S, Anderson KC. Apaf-1/cytochrome c independent and Smac dependent induction of apoptosis in multiple myeloma cells. J. Biol. Chem.276, 24453–24456 (2001).
   PubMed Web of Science ®Google Scholar
• Raje N, Kumar S, Hideshima T et al. Combination of the mTOR inhibitor Rapamycin and RevlimidTM(CC-5013) has synergistic activity in multiple myeloma. Blood104, 4188–4193 (2004).
   PubMed Web of Science ®Google Scholar
• D’Amato RJ, Loughman MS, Flynn E, Folkman J. Thalidomide is an inhibitor of angiogenesis. Proc. Natl Acad. Sci. USA91, 4082–4085 (1994).
   PubMed Web of Science ®Google Scholar
• Fujita K, Asami Y, Tanaka K, Akita M, Merker HJ. Anti-angiogenic effects of thalidomide: expression of apoptosis-inducible active-caspase-3 in a three-dimensional collagen gel culture of aorta. Histochem. Cell Biol.122, 27–33 (2004).
   PubMed Web of Science ®Google Scholar
• Lentzsch S, Rogers MS, LeBlanc R et al. S-3-amino-phthalimido-glutarimide inhibits angiogenesis and growth of B-cell neoplasias in mice. Cancer Res.62(8), 2300–2305 (2002).
   PubMed Web of Science ®Google Scholar
• Lentzsch S, LeBlanc R, Podar K et al. Immunodulatory analogs of thalidomide inhibit growth of HS Sultan cells and angiogenesis in vivo. Leukemia17, 41–44 (2003).
   PubMed Web of Science ®Google Scholar
• Singhal S, Mehta J, Desikan R et al. Antitumor activity of thalidomide in refractory multiple myeloma. N. Engl. J. Med.341(21), 1565–1571 (1999).
   PubMed Web of Science ®Google Scholar
• Kenyon BM, Browne F, D’Amato RJ. Effects of thalidomide and related metabolites in a mouse corneal model of neovascularization. Exp. Eye Res.64, 971–978 (1997).
   PubMed Web of Science ®Google Scholar
• Bauer KS, Dixon SC, Figg WD. Inhibition of angiogenesis by thalidomide requires metabolic activation, which is species-dependent. Biochem. Pharmacol.55, 1827–1834 (1998).
   PubMed Web of Science ®Google Scholar
• Davies FE, Raje N, Hideshima T et al. Thalidomide and immunomodulatory derivatives augment natural killer cell cytotoxicity in multiple myeloma. Blood98(1), 210–216 (2001).
   PubMed Web of Science ®Google Scholar
• Haslett PAJ, Corral LG, Albert M, Kaplan G. Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production, and cytotoxic responses in the CD8+ subset. J. Exp. Med.187, 1885–1892 (1998).
   PubMed Web of Science ®Google Scholar
• Hayashi T, Hideshima T, Akiyama M et al. Molecular mechanisms whereby immunomodulatory drugs activate natural killer cells: clinical application. Br. J. Haematol.128, 192–203 (2005).
   PubMed Web of Science ®Google Scholar
• LeBlanc R, Hideshima T, Catley LP et al. Immunomodulatory drug costimulates T cells via the B7-CD28 pathway. Blood103, 1787–1790 (2004).
   PubMed Web of Science ®Google Scholar
• Raje N, Anderson KC. Thalidomide: a revival story. N. Engl. J. Med.341, 1606–1609 (1999).
   PubMed Web of Science ®Google Scholar
• Hales BF. Thalidomide on the comeback trail. Nat. Med.5, 489–490 (1999).
   PubMed Web of Science ®Google Scholar
• Zeldis JB, Williams BA, Thomas SD, Elsayed ME. S.T.E.P.S.: a comprehensive program for controlling and monitoring access to thalidomide. Clin. Ther.21, 319–330 (1999).
   PubMed Web of Science ®Google Scholar
• Barlogie B, Desikan R, Eddlemon P et al. Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a Phase 2 study of 169 patients. Blood98(2), 492–494 (2001).
   PubMed Web of Science ®Google Scholar
• Yakoub-Agha I, Hulin C, Doyen C et al. A multicenter prospective randomized study testing non-inferiority of thalidomide 100mg/day as compared with 400mg/day in patients with refractory/relapsed multiple myeloma: first results of the final analysis of the IFM 01–02 study. Blood106(11), 364 (2005).
   Google Scholar
• Palumbo A, Bertola A, Musto P et al. Oral melphalan, prednisone, and thalidomide for newly diagnosed patients with myeloma. Cancer104(7), 1428–1433 (2005).
   PubMed Web of Science ®Google Scholar
• Palumbo A, Bringhen S, Caravita T et al. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet367(9513), 825–831 (2006).
   PubMed Web of Science ®Google Scholar
• Facon T, Mary JY, Hulin C et al. Major superiority of melphalan – prednisone (MP) + thalidomide (THAL) over MP and autologous stem cell transplantation in the treatment of newly diagnosed elderly patients with multiple myeloma. Blood106(11), 780 (2005).
   Google Scholar
• Alexanian R, Barlogie B, Tucker S. VAD-based regimens as primary treatment for multiple myeloma. Am. J. Hematol.33, 86–89 (1990).
   PubMed Web of Science ®Google Scholar
• Rajkumar SV, Hayman S, Gertz MA et al. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J. Clin. Oncol.20(21), 4319–4323 (2002).
   PubMed Web of Science ®Google Scholar
• Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J. Clin. Oncol.21(1), 16–19 (2003).
   PubMed Web of Science ®Google Scholar
• Rajkumar SV, Blood E, Vesole D, Fonseca R, Greipp PR. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J. Clin. Oncol.24(3), 431–436 (2006).
   PubMed Web of Science ®Google Scholar
• Cavo M, Zamagni E, Tosi P et al. Superiority of thalidomide and dexamethasone over vincristine-doxorubicindexamethasone (VAD) as primary therapy in preparation for autologous transplantation for multiple myeloma. Blood106(1), 35–39 (2005).
   PubMed Web of Science ®Google Scholar
• Barlogie B, Tricot G, Anaissie E et al. Thalidomide and hematopoietic-cell transplantation for multiple myeloma. N. Engl. J. Med.354(10), 1021–1030 (2006).
   PubMed Web of Science ®Google Scholar
• Wang M, Delasalle K, Giralt S, Alexanian R. Rapid control of previously untreated multiple myeloma with bortezomib–thalidomide–dexamethasone followed by early intensive therapy. Blood106(11), 784 (2005).
   Web of Science ®Google Scholar
• Attal M, Harousseau JL, Leyvraz S et al. Maintenance treatment with thalidomide after autologous transplantation for myeloma: final analysis of a prospective randomized study of the ‘Intergroupe Francophone du Myelome’. Blood106(11) 1148 (2005).
   Google Scholar
• Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat. Rev. Cancer4, 314–322 (2004).
   PubMed Web of Science ®Google Scholar
• Richardson PG, Schlossman RL, Weller E et al. Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood100, 3063–3067 (2002).
   PubMed Web of Science ®Google Scholar
• Richardson PG, Jagannath S, Hussein MA et al. A multicenter, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide in subjects with relapsed and refractory multiple myeloma. Haematologica90(Suppl. 1), 154 (2005).
   PubMed Web of Science ®Google Scholar
• Richardson P, Jagannath S, Schlossman R et al. A multi-center, randomized, Phase II study to evaluate the efficacy and safety of two CDC-5013 dose regimens when used alone or in combination with dexameyhasone (Dex) for the treatment of relapsed or refractory multiple myeloma (MM). Blood100, 104A (2002).
   Google Scholar
• Weber DM, Chen C, Niesvizky R et al. A multicenter, randomized, parallel-group, double-blind, placebo-controlled study of lenalidomide plus dexamethasone versus dexamethasone alone in previously treated subjects with nultiple myeloma. Haematologica2005, 155 (2005).
   Google Scholar
• Dimopoulos MA, Spencer A, Attal M et al. Study of lenalidomide plus dexamethasone versus dexamethasone alone in relapsed or refractory multiple myeloma (MM), results of a Phase 3 study (MM-010). Blood106(11), 6 (2005).
   Web of Science ®Google Scholar
• Richardson P, Schlossman R, Munshi N et al. A Phase 1 trial of lenalidomide (Revlimid®) with bortezomib (Velcade®) in relapsed and refractory multiple myeloma. Blood106(11), 365 (2005).
   Web of Science ®Google Scholar
• Rajkumar SV, Hayman S, Lacy MQ et al. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood106(13), 4050–4053 (2005).
   PubMed Web of Science ®Google Scholar
• Richardson PG, Jagannath S, Schlossman R et al. A multi-center, randomized, Phase 2 study to evaluate the efficacy and safety of 2 CDC-5013 dose regimens when used alone or in combination with dexamethasone (Dex) for the treatment of relapsed or refractory multiple myeloma (MM). Blood102, 235A (2003).
   Google Scholar