A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy
1 other identifier
interventional
195
21 countries
162
Brief Summary
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 participants 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, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of \>= 10 at screening, and be anemic with hemoglobin (Hgb) \< 10 gram/deciliter (g/dL). For participants 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. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants 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 participants tolerates and continues to benefit from MMB. Participants 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. Participants 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2020
Typical duration for phase_3
162 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedStudy Start
First participant enrolled
February 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2021
CompletedResults Posted
Study results publicly available
December 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2022
CompletedNovember 1, 2023
October 1, 2023
1.8 years
November 20, 2019
December 1, 2022
October 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Symptom Score (TSS) Response Rate at Week 24
Myelofibrosis Symptom Assessment Form (MFSAF) TSS version (v) 4.0 response rate was defined as percentage of participants with a \>= 50 percent (%) reduction from Baseline in mean MFSAF TSS over consecutive 28-day period immediately before end of Week 24. TSS response rate was measured using MFSAF v4.0. MFSAF v4.0 comprises 7 domains representing 7 most relevant symptoms of myelofibrosis (MF) identified through existing participant and clinician-based evidence: fatigue,night sweats,pruritus,abdominal discomfort,pain under left ribs,early satietyand bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0(absent) to 10(worst imaginable). The MFSAF TSS was calculated as sum of scores of 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date.
Baseline and Week 24
Secondary Outcomes (20)
Percentage of Participants With Transfusion Independence (TI) at Week 24
Week 24
Splenic Response Rate (SRR) of >=25% at Week 24
Baseline and Week 24
Change From Baseline in MFSAF TSS at Week 24
Baseline and Week 24
Splenic Response Rate (SRR) of >= 35% at Week 24
Baseline and Week 24
Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks
Up to 24 weeks
- +15 more secondary outcomes
Study Arms (2)
Momelotinib
EXPERIMENTALParticipants will receive momelotinib plus placebo to match danazol
Danazol
ACTIVE COMPARATORParticipants will receive danazol plus placebo to match momelotinib
Interventions
Momelotinib tablets will be self-administered orally once daily
Danazol placebo capsules will be self-administered orally twice daily
Danazol capsules will be self-administered orally twice daily
Momelotinib placebo tablets will be self-administered orally once daily
Eligibility Criteria
You may qualify if:
- Age \>= 18 years.
- Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post- polycythemia vera/essential thrombocythemia (PV/ET) MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT criteria).
- Symptomatic, defined as a TSS of \>= 10 units assessed by a single MFSAF v4.0 assessment during Screening prior to Baseline period (Day BL1).
- Anemic, defined as a Hgb \< 10 g/dL in Screening/Baseline period.
- Previously treated with an approved JAK inhibitor for PMF or Post-PV/ET MF for \>= 90 days, or \>= 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of \>= 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma.
- Baseline splenomegaly, defined as having a palpable spleen at \>= 5 centimeter (cm), below the left costal margin, or with volume \>= 450 cubic centimeter (cm\^3) on imaging (ultrasound, magnetic resonance imaging \[MRI\] or computed tomography \[CT\] are acceptable), assessed during Screening at any point prior to Randomization.
- High risk, intermediate-2, or intermediate-1 risk MF as defined by Dynamic International Prognostic Scoring System (DIPSS), or DIPSS-plus.
- No allogeneic stem cell transplant planned.
- Acceptable laboratory assessments:
- Absolute neutrophil count (ANC) \>= 0.75 × 10\^9/Liter (L).
- Platelet count (PLT) \>= 25 × 10\^9/L (without requirement for platelet transfusion).
- Peripheral blast count \< 10%.
- Alanine aminotransferase/ glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/ serum glutamic-pyruvic transaminase (ALT/SGPT) \<= 3 × Upper Limit Normal (ULN) (\<= 5 × ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days).
- Calculated creatinine clearance (CCr) \>= 30 milliliter per minute (mL/min) according to Cockcroft-Gault.
- Direct bilirubin \<= 2.0 × ULN.
You may not qualify if:
- Use of the following treatments within the time periods noted:
- Prior momelotinib treatment at any time.
- Approved JAK inhibitor therapy (eg, fedratinib or ruxolitinib) within 1 week prior to the first day of Baseline.
- Active anti-MF therapy within 1 week prior to the first day of Baseline.
- Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior to Randomization.
- Investigational agent (including investigational JAK inhibitors) within 4 weeks prior to Randomization.
- Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization.
- Danazol within 3 months prior to Randomization.
- Splenic irradiation within 3 months prior to Randomization.
- Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin.
- History of prostate cancer, with the exception of localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured.
- Prostate specific antigen (PSA) \> 4 nanograms per milliliter (ng/mL).
- Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI scan or CT scan for spleen volume measurement per protocol requirements.
- Any of the following (criteria a - k):
- Uncontrolled intercurrent illness including, but not limited to: active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial).
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (167)
Mayo Clinic Hospital - Phoenix
Phoenix, Arizona, 85054, United States
Irvine Center for Clinical Research
Irvine, California, 92614, United States
Norris Comprehensive Cancer Center
Los Angeles, California, 91011, United States
American Institute of Research - Whittier
Whittier, California, 90603, United States
University of Colorado Hospital Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwest Oncology & Hematology - Rolling Meadows
Rolling Meadows, Illinois, 60008, United States
Washington University School of Medicine in Saint Louis
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Irving Medical Center - Presbyterian Hospital
New York, New York, 10032, United States
Cleveland Clinic - Richard E. Jacobs Health Center
Avon, Ohio, 44011, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Canberra Region Cancer Centre
Garran, Australian Capital Territory, 2605, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Perth Radiological Clinic - Magnetic Resonance Centre
Perth, Western Australia, 6000, Australia
Medizinische Universität Innsbruck
Innsbruck, Tyrol, 6020, Austria
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, 4020, Austria
Medizinische Universität Wien
Vienna, Vienna, 1090, Austria
Oberösterreichische Gesundheitsholding GmbH
Steyr, 4400, Austria
Hôpital Erasme
Brussels, Brussels Capital, 1070, Belgium
Grand Hôpital de Charleroi - Notre Dame
Charleroi, Hainaut, 6000, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Bruges, West-Vlaanderen, 8000, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060, Belgium
Centre Hospitalier Universitaire de Liège
Liège, B-4000, Belgium
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, 5800, Bulgaria
University Hospital St. Ivan Rilski
Sofia, 1431, Bulgaria
University Multiprofile Hospital For Active Treatment Aleksandrovska
Sofia, 1431, Bulgaria
National Specialized Hospital for Active Treatment of Haematologic Diseases
Sofia, 1756, Bulgaria
Saint Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Queen Elizabeth II Health Sciences Centre - Halifax Infirmary
Halifax, Nova Scotia, B3H 1V7, Canada
McMaster University Medical Center
Hamilton, Ontario, L8V 5C2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, H3H 2R9, Canada
Hôpital de l'Enfant-Jésus
Québec, G1J 1Z4, Canada
Fakultni Nemocnice Brno
Brno, Jihormoravsky Kraj, 625 00, Czechia
Herlev Hospital
Herlev, Capital Region, 2730, Denmark
Aalborg Universitetshospital - Syd
Aalborg, North Denmark, 9000, Denmark
Sjællands Universitetshospital - Roskilde
Roskilde, Region Sjælland, 4000, Denmark
Odense Universitetshospital
Odense, Region Syddanmark, 5000, Denmark
Hôpital Haut-Lévêque
Pessac, Aquitaine, 33604, France
Hospital Center University Of Caen Normandie
Caen, Basse-Normandie, 14033, France
Hôpital Claude Huriez
Lille, Hauts-de-France, 59037, France
Centre Hospitalier Universitaire Limoges
Limoges, Limousin, 87042, France
Centre Hospitalier De Lens
Lens, Nord Pas-Des-Calais, 62307, France
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, 72037, France
Centre Hospitalier Universitaire Amiens-Picardie - Site Sud
Amiens, Picardie, 80054, France
Hôpital l'Archet
Nice, Provence-Alpes-Côte d'Azur Region, 06200, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Rhone-Alps, 69495, France
Centre Hosptitalier Universitaire Angers
Angers, 49 933, France
Hôpital Saint-Vincent De Paul - Lille
Lille, 59000, France
Hôpital De La Conception
Marseille, 13385, France
Hôpital Emile Muller
Mulhouse, 68100, France
Centre Hospitalier Universitaire Nantes - Hôtel Dieu
Nantes, 44000, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Hôpital Saint-Louis
Paris, Île-de-France Region, 75010, France
Hôpital Saint-Antoine
Paris, Île-de-France Region, 75571, France
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, 32429, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Universitätsklinikum Halle
Halle, Saxony-Anhalt, 06120, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
Uniklinik Köln
Cologne, 50937, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23538, Germany
Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
Mutlangen, 73557, Germany
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, 7624, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, 4032, Hungary
Szent Borbála Kórház
Tatabánya, Komárom-Esztergom, 2800, Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely
Budapest, Pest County, 1097, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, 7400, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Markusovszky Egyetemi Oktatókórház Szombathely
Szombathely, Vas County, 9700, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, 9023, Hungary
Yitzhak Shamir Medical Center
Be’er Ya‘aqov, Central District, 7030000, Israel
Bnai Zion Medical Center
Haifa, Haifa District, 31048, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Western Galilee Hospital-Nahariya
Nahariya, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Azienda Ospedaliero - Universitaria Careggi
Florence, Florence, 50134, Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, 47014, Italy
Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
Monza, Monza E Brianza, 20900, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Pesaro E Urbino, 61121, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero in Vulture, Potenza, 85028, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin, 10126, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Turin, 10128, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria
Alessandria, 15121, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
Bologna, 40138, Italy
Ospedale Policlinico San Martino
Genova, 16132, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, 28100, Italy
Umberto I - Policlinico di Roma
Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 20123, Italy
Presidio Ospedaliero Universitario Santa Maria della Misericordia
Udine, 33100, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, 21100, Italy
Ospedale Policlinico Giambattista Rossi Borgo Roma
Verona, 37134, Italy
North Shore Hospital
Auckland, 0622, New Zealand
Middlemore Clinical Trials
Auckland, 2025, New Zealand
Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Lesser Poland Voivodeship, 31-826, Poland
Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, Lower Silesian Voivodeship, 50-367, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Lublin Voivodeship, 20-081, Poland
Instytut Hematologii I Transfuzjologii
Warsaw, Masovian Voivodeship, 02-776, Poland
Alvamed Zakład Specjalistycznej Opieki Zdrowotnej
Warsaw, Masovian Voivodeship, 03-401, Poland
Szpital Wojewódzki w Opolu
Opole, Opole Voivodeship, 45-064, Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Silesian Healthy Blood Clinic
Chorzów, Salskie, 41-503, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, 93-513, Poland
Spitalul Filantropia - Craiova
Craiova, Dolj, 200143, Romania
Institutul Regional De Oncologie Iasi
Iași, Iaşi, 700483, Romania
Spitalul Clinic Judetean De Urgenta Târgu Mureș
Târgu Mureş, Mureș County, 540136, Romania
Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov
Brasov, 500366, Romania
Coltea - Spital Clinic
Bucharest, 030 171, Romania
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Kyungpook National University Hospital
Daegu, Daegu Gwang'yeogsi, 41944, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital
Seoul, 03722, South Korea
The Catholic University of Korea Seoul Saint Mary's Hospital
Seoul, 06591, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, 08035, Spain
Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital San Pedro de Alcantara
Cáceres, 10003, Spain
Institut Català d'Oncologia Girona
Girona, 17007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Universitario La Fe
Valencia, 46009, Spain
Hospital de Día Quirónsalud Zaragoza
Zaragoza, 50012, Spain
Karolinska Universitetssjukhuset Solna
Solna, Stockholm County, 171 76, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, 413 45, Sweden
Uddevalla Sjukhus
Uddevalla, 45153, Sweden
Chiayi Chang Gung Memorial Hospital
Buzi, Chaiyi, 613, Taiwan
China Medical University Hospital
Taichung, Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District, 333, Taiwan
United Lincolnshire Hospitals NHS Trust
Boston, England, PE21 9QS, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, England, BS2 8ED, United Kingdom
University College London Hospitals NHS Foundation Trust
London, England, NW1 2PG, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
London, England, SE1 9RT, United Kingdom
Imperial College Healthcare NHS Trust
London, England, W12 0HS, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, England, SO16 6YD, United Kingdom
NHS Lanarkshire
Airdrie, Scotland, ML6 0JS, United Kingdom
Related Publications (6)
Yoon SS, Chen CC, Lee SE, Chang H, Cheong JW, Hou HA, Lee WS, Lim SN, Moon JH, Ong KH, Dai Y, Liu C, Kawashima J, Goh YT. Efficacy and safety of momelotinib in Janus kinase inhibitor-experienced Asian patients with myelofibrosis and anemia. Int J Hematol. 2025 Nov;122(5):660-670. doi: 10.1007/s12185-025-04037-6. Epub 2025 Jul 21.
PMID: 40691344DERIVEDMesa 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.
PMID: 40535755DERIVEDHarrison 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.
PMID: 39516087DERIVEDGerds AT, Verstovsek S, Vannucchi AM, Al-Ali HK, Lavie D, Kuykendall AT, Grosicki S, Iurlo A, Goh YT, Lazaroiu MC, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Granacher N, Lee SE, Ocroteala L, Passamonti F, Harrison CN, Oh S, Klencke BJ, Yu J, Donahue R, Kawashima J, Mesa R. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study. Lancet Haematol. 2023 Sep;10(9):e735-e746. doi: 10.1016/S2352-3026(23)00174-6. Epub 2023 Jul 27.
PMID: 37517413DERIVEDVerstovsek 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.
PMID: 37042865DERIVEDVerstovsek S, Gerds AT, Vannucchi AM, Al-Ali HK, Lavie D, Kuykendall AT, Grosicki S, Iurlo A, Goh YT, Lazaroiu MC, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Granacher N, Lee SE, Ocroteala L, Passamonti F, Harrison CN, Klencke BJ, Ro S, Donahue R, Kawashima J, Mesa R; MOMENTUM Study Investigators. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study. Lancet. 2023 Jan 28;401(10373):269-280. doi: 10.1016/S0140-6736(22)02036-0.
PMID: 36709073DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- Sierra Oncology LLC - a GSK company
Study Officials
- PRINCIPAL INVESTIGATOR
Srdan Verstovsek, M.D., Ph.D.
Department of Leukemia, The University of Texas MD Anderson Cancer Center
- PRINCIPAL INVESTIGATOR
Ruben Mesa
UT Health San Antonio Cancer Center, San Antonio, TX, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- During the 24 week randomized treatment phase of the study, participants, investigators and sponsor and relevant vendor personnel (with the exception of specified unblinded personnel, for example clinical supply) will remain blinded to the participant's treatment assignment and to aggregate data that may lead to inadvertent unblinding. Participants who continue treatment with momelotinib or danazol after Week 24 in the extended treatment phase will receive unblinded treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2019
First Posted
November 22, 2019
Study Start
February 7, 2020
Primary Completion
December 3, 2021
Study Completion
December 29, 2022
Last Updated
November 1, 2023
Results First Posted
December 22, 2022
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share