Simplify 1

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Phase

Phase 3

Status

Completed

Conditions

Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis

Interventions

Momelotinib; Ruxolitinib; Placebo to match momelotinib; Placebo to match ruxolitinib

Arms

• Momelotinib · Experimental
• Ruxolitinib · Active comparator

Enrollment

432

Primary outcomes

• Splenic Response Rate at Week 24

Sponsor

Sierra Oncology LLC - a GSK company

Start

Dec 6, 2013

Primary completion

Sep 12, 2016

Results posted

Yes

Registry record

NCT01969838 · updated May 12, 2023

• Palandri F, O'Connell C, Vachhani P, McLornan DP, Koschmieder S, Hernandez-Boluda JC, Shimoda K, Zhang S, Ellis C, Lim J, Sahni J, Gupta V. Impact of Hemoglobin Improvement on Survival in Patients With Myelofibrosis and Anemia Treated With Momelotinib in the SIMPLIFY-1 and MOMENTUM Trials. Eur J Haematol. 2026 Jul 14. doi: 10.1111/ejh.70237. Online ahead of print. PubMed 42452788
• Pemmaraju N, Lucchesi A, Oh ST, Wilson K, Hakimi Z, Buckley SA, Suthar P, Parkitny M, Wojciechowski P, Kolonko K, Mascarenhas JO. Efficacy of pacritinib versus momelotinib in patients with thrombocytopenic myelofibrosis: a matching-adjusted indirect treatment comparison. Expert Rev Hematol. 2026 Sep;19(9):1107-1115. doi: 10.1080/17474086.2026.2686813. Epub 2026 Jun 30. PubMed 42316774
• Mesa R, Palmer JM, Palandri F, Masarova L, Harrison CN, Mazerolle F, M'hari M, Liu T, Zhang S, Cardellino A, Wang Z, Ellis CE, Patnaik D, Regnault A, LeBlanc TW. Association Between Transfusion Status, Hemoglobin Levels, and Patient-Reported Outcomes in Myelofibrosis: A Post Hoc Clinical Trial Analysis. Cancer Med. 2026 Apr;15(4):e71729. doi: 10.1002/cam4.71729. PubMed 41958363
• Mesa RA, Talpaz M, Mazerolle F, Gorsh B, M'Hari M, Regnault A, Ellis C, Wang Z, Purser M, Liu T, Strouse B, Patnaik D. Time Without Transfusion Reliance (TWiTR): Integrating Survival Quality Into Myelofibrosis Treatment Strategies Based on the Phase 3 SIMPLIFY-1, SIMPLIFY-2, and MOMENTUM Trials. EJHaem. 2025 Jun 18;6(3):e70075. doi: 10.1002/jha2.70075. eCollection 2025 Jun. PubMed 40535755
• Harrison CN, Mesa R, Talpaz M, Gupta V, Gerds AT, Perkins A, Goh YT, Fox ML, McLornan D, Palmer J, Foltz L, Vannucchi A, Koschmieder S, Passamonti F, Lee SE, Ellis C, Strouse B, Gonzalez Carreras FJ, Oh ST. Longitudinal Assessment of Transfusion Intensity in Patients With JAK Inhibitor-Naive or -Experienced Myelofibrosis Treated With Momelotinib. Clin Lymphoma Myeloma Leuk. 2025 Mar;25(3):199-211. doi: 10.1016/j.clml.2024.10.001. Epub 2024 Oct 16. PubMed 39516087
• Gupta V, Oh S, Devos T, Dubruille V, Catalano J, Somervaille TCP, Platzbecker U, Giraldo P, Kosugi H, Sacha T, Mayer J, Illes A, Ellis C, Wang Z, Gonzalez Carreras FJ, Strouse B, Mesa R. Momelotinib vs. ruxolitinib in myelofibrosis patient subgroups by baseline hemoglobin levels in the SIMPLIFY-1 trial. Leuk Lymphoma. 2024 Jul;65(7):965-977. doi: 10.1080/10428194.2024.2328800. Epub 2024 Mar 19. PubMed 38501751
• Verstovsek S, Mesa R, Gupta V, Lavie D, Dubruille V, Cambier N, Platzbecker U, Hus M, Xicoy B, Oh ST, Kiladjian JJ, Vannucchi AM, Gerds A, Egyed M, Mayer J, Sacha T, Kawashima J, Morris M, Huang M, Harrison C. Momelotinib long-term safety and survival in myelofibrosis: integrated analysis of phase 3 randomized controlled trials. Blood Adv. 2023 Jul 25;7(14):3582-3591. doi: 10.1182/bloodadvances.2022009311. PubMed 37042865