AzTrials
AzTrials

Primary MyelofibrosisPhase 3NCT04173494

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)

A Phase 3 study testing Momelotinib and Danazol in people with Primary Myelofibrosis and Post-polycythemia Vera Myelofibrosis, run by Sierra Oncology LLC - a GSK company at 167 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Momelotinib and Danazol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
167 sitesin 22 countries
Study dates
7 Feb 2020to 29 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).
  • Significant active or chronic bleeding event >= Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization.
  • Unstable angina pectoris within 6 months prior to Randomization.
  • Symptomatic congestive heart failure within 6 months prior to Randomization.
  • Uncontrolled cardiac arrhythmia within 6 months prior to Randomization.
  • QT Interval Corrected Using Fridericia's Formula (QTcF) interval > 500 millisecond (msec), unless attributed to bundle branch block.
  • Current progressive thrombosis despite treatment.
  • History of porphyria.
  • Child-Pugh score >= 10.
  • Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor.
  • Inability or unwillingness to comply with the protocol restrictions on MF therapy and other medications prior to and during study treatment.
  • Participants with a prior or concurrent malignancy, whose natural history or treatment has a significant potential to interfere with the safety or efficacy assessment of the investigational regimen.
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding or thalassemia.
  • Known positive status for human immunodeficiency viruses (HIV).
  • Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier (testing required for hepatitis B and C).
  • Unresolved non-hematologic toxicities from prior therapies that are > Grade 1 per CTCAE v5.0.
  • Presence of peripheral neuropathy >= Grade 2 per CTCAE v5.0.
  • Women who are already pregnant or lactating. Additional inclusion/exclusion criteria may apply.

Trial locations and contacts

167 sites in 22 countries.

167 sites in 22 countries

Italy20 sites

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria

    Alessandria, 15121

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, Florence, 50134

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Forli-Cesena, 47014

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo

    Monza, Monza E Brianza, 20900

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara, 28100

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, Pesaro E Urbino, 61121

  • IRCCS Centro di Riferimento Oncologico di Basilicata

    Rionero in Vulture, Potenza, 85028

  • Umberto I - Policlinico di Roma

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 20123

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

    Torino, Turin, 10126

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, Turin, 10128

  • Presidio Ospedaliero Universitario Santa Maria della Misericordia

    Udine, 33100

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

  • Ospedale Policlinico Giambattista Rossi Borgo Roma

    Verona, 37134

Other trials in Italy

United States17 sites

  • University of Colorado Hospital Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Cleveland Clinic - Richard E. Jacobs Health Center

    Avon, Ohio, 44011

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Irvine Center for Clinical Research

    Irvine, California, 92614

  • Norris Comprehensive Cancer Center

    Los Angeles, California, 91011

  • Columbia University Irving Medical Center - Presbyterian Hospital

    New York, New York, 10032

  • Mayo Clinic Hospital - Phoenix

    Phoenix, Arizona, 85054

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

  • Northwest Oncology & Hematology - Rolling Meadows

    Rolling Meadows, Illinois, 60008

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Washington University School of Medicine in Saint Louis

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • American Institute of Research - Whittier

    Whittier, California, 90603

Other trials in United States

France17 sites

  • Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

    Amiens, Picardie, 80054

  • Centre Hosptitalier Universitaire Angers

    Angers, 49 933

  • Hospital Center University Of Caen Normandie

    Caen, Basse-Normandie, 14033

  • Centre Hospitalier Le Mans

    Le Mans, Pays de la Loire Region, 72037

  • Centre Hospitalier De Lens

    Lens, Nord Pas-Des-Calais, 62307

  • Hôpital Claude Huriez

    Lille, Hauts-de-France, 59037

  • Hôpital Saint-Vincent De Paul - Lille

    Lille, 59000

  • Centre Hospitalier Universitaire Limoges

    Limoges, Limousin, 87042

  • Hôpital De La Conception

    Marseille, 13385

  • Hôpital Emile Muller

    Mulhouse, 68100

  • Centre Hospitalier Universitaire Nantes - Hôtel Dieu

    Nantes, 44000

  • Hôpital l'Archet

    Nice, Provence-Alpes-Côte d'Azur Region, 06200

  • Hôpital Saint-Louis

    Paris, Île-de-France Region, 75010

  • Hôpital Saint-Antoine

    Paris, Île-de-France Region, 75571

  • Hôpital Haut-Lévêque

    Pessac, Aquitaine, 33604

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Rhone-Alps, 69495

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

Other trials in France

Spain13 sites

  • Institut Hospital del Mar d'Investigacions Mèdiques

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Germans Trias i Pujol

    Barcelona, 08916

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Institut Català d'Oncologia Girona

    Girona, 17007

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario La Fe

    Valencia, 46009

  • Hospital de Día Quirónsalud Zaragoza

    Zaragoza, 50012

Other trials in Spain

Germany10 sites

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Uniklinik Köln

    Cologne, 50937

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Universitätsklinikum Halle

    Halle, Saxony-Anhalt, 06120

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, 23538

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia, 32429

  • Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557

Other trials in Germany

Israel10 sites

  • Yitzhak Shamir Medical Center

    Be’er Ya‘aqov, Central District, 7030000

  • Bnai Zion Medical Center

    Haifa, Haifa District, 31048

  • Rambam Health Care Campus

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 3436212

  • Hadassah University Hospital Ein Kerem

    Jerusalem, Jerusalem

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Meir Medical Center

    Kfar Saba, 4428164

  • Western Galilee Hospital-Nahariya

    Nahariya

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Poland10 sites

  • Silesian Healthy Blood Clinic

    Chorzów, Salskie, 41-503

  • Uniwersyteckie Centrum Kliniczne w Gdańsku

    Gdansk, Pomeranian Voivodeship, 80-214

  • Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-501

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-826

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

    Lodz, 93-513

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, Lublin Voivodeship, 20-081

  • Szpital Wojewódzki w Opolu

    Opole, Opole Voivodeship, 45-064

  • Instytut Hematologii I Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776

  • Alvamed Zakład Specjalistycznej Opieki Zdrowotnej

    Warsaw, Masovian Voivodeship, 03-401

  • Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku

    Wroclaw, Lower Silesian Voivodeship, 50-367

Other trials in Poland

Hungary9 sites

  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely

    Budapest, Pest County, 1097

  • Semmelweis Egyetem

    Budapest, 1083

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hajdú-Bihar, 4032

  • Petz Aladár Megyei Oktató Kórház

    Győr, 9023

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Somogy County, 7400

  • Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7624

  • Markusovszky Egyetemi Oktatókórház Szombathely

    Szombathely, Vas County, 9700

  • Szent Borbála Kórház

    Tatabánya, Komárom-Esztergom, 2800

Other trials in Hungary

South Korea9 sites

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Kyungpook National University Hospital

    Daegu, Daegu Gwang'yeogsi, 41944

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Severance Hospital

    Seoul, 03722

  • The Catholic University of Korea Seoul Saint Mary's Hospital

    Seoul, 06591

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

United Kingdom7 sites

  • NHS Lanarkshire

    Airdrie, Scotland, ML6 0JS

  • United Lincolnshire Hospitals NHS Trust

    Boston, England, PE21 9QS

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, England, BS2 8ED

  • University College London Hospitals NHS Foundation Trust

    London, England, NW1 2PG

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, England, SE1 9RT

  • Imperial College Healthcare NHS Trust

    London, England, W12 0HS

  • University Hospital Southampton NHS Foundation Trust

    Southampton, England, SO16 6YD

Other trials in United Kingdom

Canada6 sites

  • Queen Elizabeth II Health Sciences Centre - Halifax Infirmary

    Halifax, Nova Scotia, B3H 1V7

  • McMaster University Medical Center

    Hamilton, Ontario, L8V 5C2

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H3H 2R9

  • Hôpital de l'Enfant-Jésus

    Québec, G1J 1Z4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Saint Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Australia5 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Canberra Region Cancer Centre

    Garran, Australian Capital Territory, 2605

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Perth Radiological Clinic - Magnetic Resonance Centre

    Perth, Western Australia, 6000

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298

Other trials in Australia

Belgium5 sites

  • Ziekenhuis Netwerk Antwerpen Stuivenberg

    Antwerp, 2060

  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

    Bruges, West-Vlaanderen, 8000

  • Hôpital Erasme

    Brussels, Brussels Capital, 1070

  • Grand Hôpital de Charleroi - Notre Dame

    Charleroi, Hainaut, 6000

  • Centre Hospitalier Universitaire de Liège

    Liège, B-4000

Other trials in Belgium

Romania5 sites

  • Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov

    Brasov, 500366

  • Coltea - Spital Clinic

    Bucharest, 030 171

  • Spitalul Filantropia - Craiova

    Craiova, Dolj, 200143

  • Institutul Regional De Oncologie Iasi

    Iași, Iaşi, 700483

  • Spitalul Clinic Judetean De Urgenta Târgu Mureș

    Târgu Mureş, Mureș County, 540136

Other trials in Romania

Austria4 sites

  • Medizinische Universität Innsbruck

    Innsbruck, Tyrol, 6020

  • Ordensklinikum Linz Elisabethinen

    Linz, Upper Austria, 4020

  • Oberösterreichische Gesundheitsholding GmbH

    Steyr, 4400

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

Other trials in Austria

Bulgaria4 sites

  • University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD

    Pleven, 5800

  • University Hospital St. Ivan Rilski

    Sofia, 1431

  • University Multiprofile Hospital For Active Treatment Aleksandrovska

    Sofia, 1431

  • National Specialized Hospital for Active Treatment of Haematologic Diseases

    Sofia, 1756

Other trials in Bulgaria

Denmark4 sites

  • Aalborg Universitetshospital - Syd

    Aalborg, North Denmark, 9000

  • Herlev Hospital

    Herlev, Capital Region, 2730

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000

  • Sjællands Universitetshospital - Roskilde

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Taiwan4 sites

  • Chiayi Chang Gung Memorial Hospital

    Buzi, Chaiyi, 613

  • China Medical University Hospital

    Taichung, Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götaland County, 413 45

  • Karolinska Universitetssjukhuset Solna

    Solna, Stockholm County, 171 76

  • Uddevalla Sjukhus

    Uddevalla, 45153

Other trials in Sweden

New Zealand2 sites

  • North Shore Hospital

    Auckland, 0622

  • Middlemore Clinical Trials

    Auckland, 2025

Other trials in New Zealand

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Czechia1 site

  • Fakultni Nemocnice Brno

    Brno, Jihormoravsky Kraj, 625 00

Other trials in Czechia

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

MOMENTUM Contact Email: GSKClinicalSupportHD@gsk.com

Being tested
Momelotinib, Placebo to match danazol, Danazol, Placebo to match momelotinib
Keywords
Myelofibrosis, JAK inhibitor, Danazol, Momelotinib, Functional Iron deficiency, Activin receptor type 1, Anemia, Transfusion, Hepcidin, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases
Medical subject headings
Primary Myelofibrosis, Anemia, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MomelotinibDrug

    Also called MMB, GS-0387, CYT387

    Momelotinib tablets will be self-administered orally once daily

  • Placebo to match danazolDrug

    Danazol placebo capsules will be self-administered orally twice daily

  • DanazolDrug

    Also called Danocrine

    Danazol capsules will be self-administered orally twice daily

  • Placebo to match momelotinibDrug

    Momelotinib placebo tablets will be self-administered orally once daily

Study groups in NCT04173494
Study groupRoleWhat they receive
MomelotinibExperimentalParticipants will receive momelotinib plus placebo to match danazol
Receives: Drug: Momelotinib; Drug: Placebo to match danazol
DanazolActive comparatorParticipants will receive danazol plus placebo to match momelotinib
Receives: Drug: Danazol; Drug: Placebo to match momelotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 24

Secondary outcomes (20)

  1. Percentage of Participants With Transfusion Independence (TI) at Week 24

    TI status was defined as not receiving red blood cell (RBC) or whole blood transfusion for >=12 weeks, with no hemoglobin (Hgb) level < 8 grams per deciliter (g/dL) during the same interval. Percentage of participants with TI have been presented.

    Measured: Week 24

  2. Splenic Response Rate (SRR) of >=25% at Week 24

    Splenic response rate (SRR) is defined as the percentage of participants who have reduction in spleen volume of >=25% from Baseline at the end of Week 24. Baseline was the last assessment done before or on the day of first dose date.

    Measured: Baseline and Week 24

  3. Change From Baseline in MFSAF TSS at Week 24

    TSS was measured using the MFSAF v4.0. The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing participant and clinician-based evidence: fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, and 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 the sum of scores of the 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. Change from Baseline was defined as the post-Baseline value minus Baseline value.

    Measured: Baseline and Week 24

  4. Splenic Response Rate (SRR) of >= 35% at Week 24

    Splenic response rate (SRR) is defined as the percentage of participants who have reduction in spleen volume of >=35 % from Baseline at the end of Week 24. Baseline was the last assessment done before or on the day of first dose date.

    Measured: Baseline and Week 24

  5. Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks

    Percentage of participants with zero RBC units transfused over 24-weeks were reported.

    Measured: Up to 24 weeks

  6. Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks

    Percentage of participants with <=4 RBC units transfused over 24-weeks were reported.

    Measured: Up to 24 weeks

  7. Duration of MFSAF TSS Response

    Duration of MFSAF TSS response is defined as the number of days from the start of the initial 28-day period in which a participant had a >= 50% reduction from Baseline TSS to the first day of the 7-day assessment that determines the mean TSS for the 28-day period during which the participants TSS equals or exceeds their Baseline value.

    Measured: Up to a maximum of 151 weeks

  8. Duration of TI Response

    Duration of TI is defined as the number of days from (a) the first day of a 12-week period that satisfies the 12-week TI status definition, to (b) the first RBC transfusion or Hgb level < 8 g/dL (except in the case of clinically overt bleeding).

    Measured: Up to a maximum of 151 weeks

  9. Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks

    Cumulative transfusion risk was calculated as the estimated mean cumulative number of whole blood units transfused during the study.

    Measured: Up to Week 24

  10. Percentage of Participants With Transfusion Dependence (TD) Status at Week 24

    TD status at Week 24 is defined as requirement of >=4 RBC units in an 8-week period immediately prior to the end of Week 24.

    Measured: Week 24

  11. Percentage of Participants With a Hemoglobin Response

    Hemoglobin responses are defined as increases of >= 1, >= 1.5, or >= 2 g/dL from Baseline in Hgb, as measured over a (rolling) period of at least 12 consecutive weeks falling entirely before the end of Week 24. Baseline was the last assessment done before or on the day of first dose date. Data has been reported for percentage of participants who had >= 1, >= 1.5, or >= 2 g/dL increase from Baseline in hemoglobin.

    Measured: Baseline and Week 24

  12. Number of Baseline TD Participants With TI Status at Week 24

    Participants were defined as having TD if they met both of the following requirements in the 8 weeks immediately before the end of Week 24: >= 4 red blood cell or whole blood units were transfused (except in the case of clinically overt bleeding), each in response to a hemoglobin assessment of <= 9.5 g/dL; and there were >= 2 hemoglobin assessments with >= 28 days between the earliest and latest hemoglobin assessments. TI status was defined as not requiring red blood cell transfusion (except in the case of clinically overt bleeding) for >= 12 weeks immediately prior to the end of Week 24, with hemoglobin levels >= 8 g/dL.

    Measured: Week 24

  13. Duration of TI in Baseline TD Participants

    Duration of TI is defined as the number of days from (a) the first day of a 12-week period that satisfies the 12-week TI status definition, to (b) the first RBC transfusion or Hgb level < 8 g/dL (except in the case of clinically overt bleeding).

    Measured: Up to a maximum of 151 weeks

  14. Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to Week 24

    An adverse event (AE) is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.

    Measured: Up to Week 24

  15. Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- From Week 24 to a Maximum of 151 Weeks

    An AE is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.

    Measured: From Week 24 to a maximum of 151 weeks

  16. Overall Survival (OS)

    Overall survival is defined as the interval from the first study drug dosing date (or randomization date for participants who did not receive treatment) to death from any cause.

    Measured: Up to a maximum of 151 weeks

  17. Leukemia-free Survival (LFS)

    LFS is defined as the interval from first study drug dosing date (or randomization date for participants who did not receive treatment) to any evidence of leukemic transformation and/or death (from any cause).

    Measured: Up to a maximum of 151 weeks

  18. Change From Baseline in Disease-related Fatigue as Assessed by MFSAF TSS v4.0 at Week 24

    The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing participant- and clinician-based evidence: fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, and bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Data has been reported for Disease-related Fatigue domain measured using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable), higher score indicates worst outcome. An increase in score from Baseline indicated a worsening of fatigue and a decrease in score from Baseline indicated an improvement in fatigue. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.

    Measured: Baseline and Week 24

  19. Change From Baseline in Cancer-related Fatigue as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at Week 24

    The EORTC QLQ-C30 is comprised of 5 functional scales (physical, role, emotional, social, cognitive), eight single item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea), as well as sub-scales assessing global health/quality of life and financial impact. Most items use a 4-point Likert scale from "not at all" to "very much" and a one-week recall period with the exception of the final two items which use a 7 point scale response from "very poor" to "excellent". Scores were averaged and transformed to a 0-100 scale, with higher scores representing better functioning/quality of life. An increase in scores from Baseline indicated an improved functioning/quality of life, and a decrease in scores from Baseline indicated a worsened functioning/quality of life. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.

    Measured: Baseline and Week 24

  20. Change From Baseline in Physical Function Score as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b at Week 24

    PROMIS Physical Function Short Form 10b consists of 14 questions; each with a 5-point response. PROMIS short form assesses self-reported capability of a participant rather than actual performance of physical activities. This includes functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) as well as instrumental activities of daily living, such as running errands. Participants scored each response on a scale from 1 (unable to do) to 5 (without any difficulty, or not at all). Total possible range of scores was 14 to 70, with higher scores corresponding to a greater physical function ability. An increase in score from Baseline indicated an improvement in physical function ability and a decrease in score from Baseline indicated a reduction in physical function ability. Baseline was last assessment done before or on the day of first dose date. Change from Baseline was defined as post-Baseline value minus Baseline value.

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2019
  2. Study start7 Feb 2020
  3. Primary completion3 Dec 2021
  4. Study completion29 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04173494
Sponsor's protocol ID
SRA-MMB-301
Status last verified
Oct 2023
First submitted
20 Nov 2019
Last updated
1 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 40691344

  • 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

  • Gerds 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.

    PubMed 37517413

  • 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

  • Verstovsek 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.

    PubMed 36709073

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Momelotinib and Danazol in people with Primary Myelofibrosis and Post-polycythemia Vera Myelofibrosis, run by Sierra Oncology LLC - a GSK company at 167 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in Italy, United States, France, Spain, Germany and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Symptom Score (TSS) Response Rate at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04173494, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.

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