Phase 3
Completed N=432
Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
Myelofibrosis · Post-Polycythemia Vera Myelofibrosis · Post-Essential Thrombocythemia Myelofibrosis
Source: ClinicalTrials.gov NCT01969838 ↗
Enrolled (actual)
432
Serious AEs
30.8%
Results posted
May 2023
Primary outcomePrimary: Splenic Response Rate at Week 24 — 57; 64; 158; 153 Participants — p=0.014
◆ Published Evidence
Established
49citations · ~16 / year
Momelotinib long-term safety and survival in myelofibrosis: integrated analysis of phase 3 randomized controlled trials.
Summary
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).
Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.
Linked Publications (5)
-
Momelotinib long-term safety and survival in myelofibrosis: integrated analysis of phase 3 randomized controlled trials.
-
Momelotinib vs. ruxolitinib in myelofibrosis patient subgroups by baseline hemoglobin levels in the SIMPLIFY-1 trial.
-
Longitudinal Assessment of Transfusion Intensity in Patients With JAK Inhibitor-Naive or -Experienced Myelofibrosis Treated With Momelotinib.
-
Time Without Transfusion Reliance (TWiTR): Integrating Survival Quality Into Myelofibrosis Treatment Strategies Based on the Phase 3 SIMPLIFY-1, SIMPLIFY-2, and MOMENTUM Trials.
-
Association Between Transfusion Status, Hemoglobin Levels, and Patient-Reported Outcomes in Myelofibrosis: A Post Hoc Clinical Trial Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Splenic Response Rate at Week 24 |
57; 64; 158; 153 | 0.014 sig |
| SECONDARY Total Symptom Score (TSS) Response Rate at Week 24 |
60; 89; 151; 122 | 0.98 |
| SECONDARY Rate of Red Blood Cell (RBC) Transfusions in the Double-blind Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) |
0.0; 0.4 | <0.001 sig |
| SECONDARY RBC Transfusion Independence Rate at Week 24, (Defined as Absence of RBC Transfusions and no Hemoglobin Level Below 8 g/dL in the 12 Weeks Prior to Week 24, Excluding Cases Associated With Clinically Overt Bleeding) |
143; 107; 72; 110 | <0.001 sig |
| SECONDARY RBC Transfusion Dependence Rate at Week 24. (Defined as Having Had at Least 4 Units of RBC Transfusions, or a Hemoglobin Level Below 8 g/dL in 8 Weeks Prior to Week 24 (Excluding Cases Associated With Clinically Overt Bleeding)). |
65; 87; 150; 130 | 0.019 sig |
Eligibility Criteria
Key Inclusion Criteria
- Palpable splenomegaly at least 5 cm below the left costal margin
- Confirmed diagnosis of PMF or post-PV/ET MF
- Requires myelofibrosis therapy, in the opinion of the investigator
- Classified as high risk OR intermediate-2 risk as defined by the International Prognostic Scoring System (IPSS) for PMF, or intermediate-1 risk (IPSS) associated with symptomatic splenomegaly, hepatomegaly, anemia (hemoglobin 24 weeks
- Males and females of childbearing potential must agree to use protocol-specified method(s) of contraception
- Females who are nursing must agree to discontinue nursing before the first dose of study drug
- Able to understand and willing to sign the informed consent form
Key Exclusion Criteria
- Prior splenectomy
- Splenic irradiation within 3 months prior to the first dose of study drug
- Eligible for allogeneic bone marrow or stem cell transplantation
- Uncontrolled inter-current illness, per protocol.
- Known positive status for human immunodeficiency virus (HIV)
- Chronic active or acute viral hepatitis A, B, or C infection, or a hepatitis B or C carrier
- Prior use of a JAK1 or JAK2 inhibitor
- Use of chemotherapy, immunomodulating therapy, biologic therapy, radiation therapy, or investigational therapy within 4 weeks of the first dose of study drug
- Presence of peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
- Unwilling or unable to undergo a magnetic resonance imaging (MRI) or computed tomography (CT) scan
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01969838) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.