MOMENTUM Clinical Trial
MOMENTUM (NCT04173494) is a randomized, double-blind Phase 3 clinical trial of momelotinib versus danazol (n=180; 2:1) in symptomatic, anemic patients previously treated with an approved JAK inhibitor. The study is designed to confirm [in a statistically compelling manner] the unique benefits of momelotinib on all three hallmarks of myelofibrosis (MF): symptoms, anemia and splenomegaly.
The primary endpoint of the study is the MFSAF Total Symptom Score (TSS) response rate at Week 24. Secondary endpoints include confirmatory measures of anemia benefit and splenic response rate.
Danazol has been selected as an appropriate treatment comparator given its use to ameliorate anemia in myelofibrosis patients, as recommended by NCCN and ESMO guidelines. Patients will be randomized 2:1 to receive either momelotinib or danazol. After 24 weeks of treatment, patients on danazol will be allowed to crossover to receive momelotinib. Early cross-over to momelotinib is available for confirmed symptomatic splenic progression.
The study’s co-Chief Investigators are Dr. Srdan Verstovsek, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas and Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center. Both Dr. Verstovsek and Dr. Mesa are world-renowned clinician scientists in the myeloproliferative neoplasm field. Dr. Verstovsek and Dr. Mesa have been involved in the development of most of the investigational and approved agents for the treatment of myelofibrosis. In particular, Dr. Verstovsek and Dr. Mesa have been involved in the development of momelotinib since 2011, both as advisors and as clinical investigators.