A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Patients (MOMENTUM)
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|ClinicalTrials.gov Identifier: NCT04173494|
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : June 2, 2020
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic subjects who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, UK, and US.
Subjects must be symptomatic with a MFSAF v4.0 Total Symptom Score of ≥ 10 at screening, and be anemic with Hgb < 10 g/dL. For subjects with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization.
Subjects will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Subjects randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the subject tolerates and continues to benefit from MMB.
Subjects randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances:
- at the end of Week 24 if they complete the randomized treatment period; or
- at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or
- at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically-confirmed symptomatic splenic progression.
Subjects randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.
|Condition or disease||Intervention/treatment||Phase|
|Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis||Drug: Momelotinib Drug: Danazol Drug: Placebo to match momelotinib Drug: Placebo to match danazol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||During the 24 week randomized treatment phase of the study, subjects, investigators and sponsor and relevant vendor personnel (with the exception of specified unblinded personnel, for example clinical supply) will remain blinded to the subject's treatment assignment and to aggregate data that may lead to inadvertent unblinding. Subjects who continue treatment with momelotinib or danazol after Week 24 in the extended treatment phase will receive unblinded treatment.|
|Official Title:||A Randomized, Double-Blind, Phase 3 Study of Momelotinib vs Danazol in Symptomatic, Anemic Subjects With Previously JAKi Treated Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis|
|Actual Study Start Date :||November 20, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||April 2028|
Participants will receive momelotinib plus placebo to match danazol
Momelotinib tablets will be self-administered orally once daily
Other Name: MMB, GS-0387, CYT387
Drug: Placebo to match danazol
Danazol placebo capsules will be self-administered orally twice daily
Active Comparator: Danazol
Participants will receive danazol plus placebo to match momelotinib
Danazol capsules will be self-administered orally twice daily
Other Name: Danocrine
Drug: Placebo to match momelotinib
Momelotinib placebo tablets will be self-administered orally once daily
- Total Symptom Score (TSS) response rate at Week 24 measured using the Myelofibrosis Symptom Assessment Form v4.0 [ Time Frame: Week 24 landmark. ]Difference in TSS response rate at Week 24. TSS response is defined as the proportion of subjects who achieve a ≥ 50% reduction in TSS over the 28 days immediately prior to the end of Week 24 compared to baseline
- Transfusion independence (TI) status at Week 24 [ Time Frame: Week 24 landmark. ]Proportion of subjects with TI status at the end of Week 24. TI is defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for ≥ 12 weeks immediately prior to the end of Week 24, with Hgb levels ≥ 8 g/dL.
- Splenic response rate (SRR) at Week 24 [ Time Frame: Week 24 ]Proportion of subjects who have splenic response (reduction in spleen volume of ≥ 35% from baseline) at the end of Week 24
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173494
|Contact: MOMENTUM contact||Sierra_Momentum_ct.email@example.com|
|Principal Investigator:||Srdan Verstovsek, M.D., Ph.D.||Department of Leukemia, The University of Texas MD Anderson Cancer Center|