Myelofibrosis

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Pomalidomide (Pomalyst)

Regimen #1, Tefferi et al. 2009

Level of Evidence: Randomized Phase II, >20 per arm

• Pomalidomide (Pomalyst) 2 mg PO once per day

28-day cycles

Regimen #2, Begna et al. 2010

Level of Evidence: Phase II

• Pomalidomide (Pomalyst) 0.5 mg PO once per day, escalation up to 2 mg PO once per day allowed after first six cycles

28-day cycles

References

1. Tefferi A, Verstovsek S, Barosi G, Passamonti F, Roboz GJ, Gisslinger H, Paquette RL, Cervantes F, Rivera CE, Deeg HJ, Thiele J, Kvasnicka HM, Vardiman JW, Zhang Y, Bekele BN, Mesa RA, Gale RP, Kantarjian HM. Pomalidomide is active in the treatment of anemia associated with myelofibrosis. J Clin Oncol. 2009 Sep 20;27(27):4563-9. Epub 2009 Aug 3. link to original article PubMed
2. Begna KH, Mesa RA, Pardanani A, Hogan WJ, Litzow MR, McClure RF, Tefferi A. A phase-2 trial of low-dose pomalidomide in myelofibrosis. Leukemia. 2011 Feb;25(2):301-4. doi: 10.1038/leu.2010.254. Epub 2010 Nov 5. trial protocol contains verified protocol PubMed

Pomalidomide & Prednisone

Regimen #1, Tefferi et al. 2009

Level of Evidence: Randomized Phase II, <20 per arm

• Pomalidomide (Pomalyst) 2 mg PO once per day
• Prednisone (Sterapred) 30 mg PO once per day during the first cycle, 15 mg PO once per day during the second cycle, and 15 mg PO every other day during the third cycle

28-day cycles

Regimen #2, Tefferi et al. 2009

Level of Evidence: Randomized Phase II, >20 per arm

• Pomalidomide (Pomalyst) 0.5 mg PO once per day
• Prednisone (Sterapred) 30 mg PO once per day during the first cycle, 15 mg PO once per day during the second cycle, and 15 mg PO every other day during the third cycle

28-day cycles

References

1. Tefferi A, Verstovsek S, Barosi G, Passamonti F, Roboz GJ, Gisslinger H, Paquette RL, Cervantes F, Rivera CE, Deeg HJ, Thiele J, Kvasnicka HM, Vardiman JW, Zhang Y, Bekele BN, Mesa RA, Gale RP, Kantarjian HM. Pomalidomide is active in the treatment of anemia associated with myelofibrosis. J Clin Oncol. 2009 Sep 20;27(27):4563-9. Epub 2009 Aug 3. link to original article PubMed

Prednisone

Regimen, Tefferi et al. 2009

Level of Evidence: Randomized Phase II, >20 per arm

• Prednisone (Sterapred) 30 mg PO once per day during the first cycle, 15 mg PO once per day during the second cycle, and 15 mg PO every other day during the third cycle

28-day cycles

References

1. Tefferi A, Verstovsek S, Barosi G, Passamonti F, Roboz GJ, Gisslinger H, Paquette RL, Cervantes F, Rivera CE, Deeg HJ, Thiele J, Kvasnicka HM, Vardiman JW, Zhang Y, Bekele BN, Mesa RA, Gale RP, Kantarjian HM. Pomalidomide is active in the treatment of anemia associated with myelofibrosis. J Clin Oncol. 2009 Sep 20;27(27):4563-9. Epub 2009 Aug 3. link to original article PubMed

Ruxolitinib (Jakafi)

Regimen, Verstovsek et al. 2010; Harrison et al. 2012 (COMFORT-II); Verstovsek et al. 2012 (COMFORT-I)

COMFORT: COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment

Level of Evidence: Phase III

• Ruxolitinib (Jakafi) 10 to 25 mg PO twice per day

given until progression

References

1. Verstovsek S, Kantarjian H, Mesa RA, Pardanani AD, Cortes-Franco J, Thomas DA, Estrov Z, Fridman JS, Bradley EC, Erickson-Viitanen S, Vaddi K, Levy R, Tefferi A. Safety and efficacy of INCB018424, a JAK1 and JAK2 inhibitor, in myelofibrosis. N Engl J Med. 2010 Sep 16;363(12):1117-27. doi:10.1056/NEJMoa1002028. link to original article supplementary appendix contains verified protocol PubMed
2. Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, Waltzman R, Stalbovskaya V, McQuitty M, Hunter DS, Levy R, Knoops L, Cervantes F, Vannucchi AM, Barbui T, Barosi G. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):787-98. doi:10.1056/NEJMoa1110556. link to original article contains verified protocol PubMed content property of HemOnc.org
3. Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. doi:10.1056/NEJMoa1110557. link to original article supplementary appendix trial protocol contains verified protocol PubMed