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

Primary Purpose

Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Momelotinib
Danazol
Placebo to match momelotinib
Placebo to match danazol
Sponsored by
Sierra Oncology LLC - a GSK company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Myelofibrosis focused on measuring Myelofibrosis, JAK inhibitor, Danazol, Momelotinib, Functional Iron deficiency, ACVR1, Anemia, Transfusion, Hepcidin, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT criteria).
  3. Symptomatic, defined as a TSS of ≥ 10 units assessed by a single MFSAF v4.0 assessment during Screening prior to Day BL1.
  4. Anemic, defined as a Hgb < 10 g/dL in Screening/Baseline period.
  5. 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.
  6. Baseline splenomegaly, defined as having a palpable spleen at ≥ 5 cm, below the left costal margin, or with volume ≥ 450 cm³ on imaging (ultrasound, MRI or CT are acceptable), assessed during Screening at any point prior to Randomization.
  7. High risk, intermediate-2, or intermediate-1 risk MF as defined by DIPSS, or DIPSS-plus.
  8. No allogeneic stem cell transplant planned.

  9. Acceptable laboratory assessments:

    • Absolute neutrophil count (ANC) ≥ 0.75 × 10E9/L.
    • Platelet count (PLT) ≥ 25 × 10E9/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 × 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 mL/min according to Cockcroft-Gault.
    • Direct bilirubin ≤ 2.0 × ULN.

Exclusion Criteria:

  1. Use of the following treatments within the time periods noted:

    1. Prior momelotinib treatment at any time.
    2. Approved JAK inhibitor therapy (eg, fedratinib or ruxolitinib) within 1 week prior to the first day of Baseline.
    3. Active anti-MF therapy within 1 week prior to the first day of Baseline.
    4. Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior to Randomization.
    5. Investigational agent (including investigational JAK inhibitors) within 4 weeks prior to Randomization.
    6. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization.
    7. Danazol within 3 months prior to Randomization.
    8. Splenic irradiation within 3 months prior to Randomization.
    9. Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin.
  2. 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.
  3. Prostate specific antigen (PSA) > 4 ng/mL.
  4. Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI or CT scan for spleen volume measurement per protocol requirements.

  5. Any of the following (criteria a - k):

    1. Uncontrolled intercurrent illness including, but not limited to: active uncontrolled infection (subjects receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial).
    2. Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization.
    3. Unstable angina pectoris within 6 months prior to Randomization.
    4. Symptomatic congestive heart failure within 6 months prior to Randomization.
    5. Uncontrolled cardiac arrhythmia within 6 months prior to Randomization.
    6. QTcF interval > 500 msec, unless attributed to bundle branch block.
    7. Current progressive thrombosis despite treatment.
    8. History of porphyria.
    9. Child-Pugh score ≥ 10.
    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.
    11. Inability or unwillingness to comply with the protocol restrictions on MF therapy and other medications prior to and during study treatment.
  6. Subjects 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.
  7. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding or thalassemia.
  8. Known positive status for HIV.
  9. Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier (testing required for hepatitis B and C).
  10. Unresolved non-hematologic toxicities from prior therapies that are > Grade 1 per CTCAE v5.0.
  11. Presence of peripheral neuropathy ≥ Grade 2 per CTCAE v5.0.
  12. Women who are already pregnant or lactating.

Additional inclusion/exclusion criteria may apply.

Sites / Locations

  • Mayo Clinic Hospital - Phoenix
  • Irvine Center for Clinical Research
  • Norris Comprehensive Cancer Center
  • American Institute of Research - Whittier
  • University of Colorado Hospital Anschutz Cancer Pavilion
  • Georgetown University Medical Center
  • Moffitt Cancer Center
  • Northwest Oncology & Hematology - Rolling Meadows
  • Washington University School of Medicine in Saint Louis
  • Hackensack University Medical Center
  • Columbia University Irving Medical Center - Presbyterian Hospital
  • Cleveland Clinic - Richard E. Jacobs Health Center
  • Gabrail Cancer Center
  • University Hospitals Cleveland Medical Center
  • Allegheny Health Network
  • The University of Texas MD Anderson Cancer Center
  • The University of Texas Health Science Center at San Antonio
  • Canberra Region Cancer Centre
  • Calvary Mater Newcastle Hospital
  • Flinders Medical Centre
  • The Alfred Hospital
  • Perth Radiological Clinic - Magnetic Resonance Centre
  • Medizinische Universität Innsbruck
  • Ordensklinikum Linz Elisabethinen
  • Medizinische Universität Wien
  • Oberösterreichische Gesundheitsholding GmbH
  • Hôpital Erasme
  • Grand Hôpital de Charleroi - Notre Dame
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
  • Ziekenhuis Netwerk Antwerpen Stuivenberg
  • Centre Hospitalier Universitaire de Liège
  • University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
  • University Hospital St. Ivan Rilski
  • University Multiprofile Hospital For Active Treatment Aleksandrovska
  • National Specialized Hospital for Active Treatment of Haematologic Diseases
  • Saint Paul's Hospital
  • Queen Elizabeth II Health Sciences Centre - Halifax Infirmary
  • McMaster University Medical Center
  • Princess Margaret Cancer Centre
  • Research Institute of the McGill University Health Centre
  • Hôpital de l'Enfant-Jésus
  • Fakultni Nemocnice Brno
  • Herlev Hospital
  • Aalborg Universitetshospital - Syd
  • Sjællands Universitetshospital - Roskilde
  • Odense Universitetshospital
  • Hôpital Haut-Lévêque
  • Hospital Center University Of Caen Normandie
  • Hôpital Claude Huriez
  • Hôpital Saint-Louis
  • Hôpital Saint-Antoine
  • Centre Hospitalier Universitaire Limoges
  • Centre Hospitalier De Lens
  • Centre Hospitalier Le Mans
  • Centre Hospitalier Universitaire Amiens-Picardie - Site Sud
  • Hôpital l'Archet
  • Centre Hospitalier Lyon-Sud
  • Centre Hosptitalier Universitaire Angers
  • Hôpital Saint-Vincent De Paul - Lille
  • Hôpital De La Conception
  • Hôpital Emile Muller
  • Centre Hospitalier Universitaire Nantes - Hôtel Dieu
  • Centre Hospitalier Universitaire de Poitiers
  • Universitätsklinikum Aachen
  • Universitätsklinikum Essen
  • Johannes Wesling Klinikum Minden
  • Universitätsklinikum Halle
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Jena
  • Uniklinik Köln
  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
  • Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
  • Pécsi Tudományegyetem Klinikai Központ
  • Debreceni Egyetem Klinikai Központ
  • Szent Borbála Kórház
  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
  • Markusovszky Egyetemi Oktatókórház Szombathely
  • Semmelweis Egyetem
  • Petz Aladár Megyei Oktató Kórház
  • Yitzhak Shamir Medical Center
  • Bnai Zion Medical Center
  • Hadassah University Hospital Ein Kerem
  • Rambam Health Care Campus
  • Carmel Medical Center
  • Shaare Zedek Medical Center
  • Meir Medical Center
  • Western Galilee Hospital-Nahariya
  • Rabin Medical Center - Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliero - Universitaria Careggi
  • Ospedale Casa Sollievo della Sofferenza
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
  • Azienda Ospedaliera Ospedali Riuniti Marche Nord
  • IRCCS Centro di Riferimento Oncologico di Basilicata
  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
  • Azienda Ospedaliera Ordine Mauriziano di Torino
  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
  • Ospedale Policlinico San Martino
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
  • Umberto I - Policlinico di Roma
  • Fondazione Policlinico Universitario Agostino Gemelli
  • Presidio Ospedaliero Universitario Santa Maria della Misericordia
  • Ospedale di Circolo e Fondazione Macchi
  • Ospedale Policlinico Giambattista Rossi Borgo Roma
  • Kyungpook National University Hospital
  • Inje University Busan Paik Hospital
  • Inje University Haeundae Paik Hospital
  • Seoul National University Bundang Hospital
  • Severance Hospital
  • The Catholic University of Korea Seoul Saint Mary's Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Ulsan University Hospital
  • North Shore Hospital
  • Middlemore Clinical Trials
  • Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Szpital Uniwersytecki w Krakowie
  • Instytut Hematologii I Transfuzjologii
  • Alvamed Zakład Specjalistycznej Opieki Zdrowotnej
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Szpital Wojewódzki w Opolu
  • Uniwersyteckie Centrum Kliniczne w Gdańsku
  • Silesian Healthy Blood Clinic
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
  • Spitalul Filantropia - Craiova
  • Institutul Regional De Oncologie Iasi
  • Spitalul Clinic Judetean De Urgenta Târgu Mureș
  • Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov
  • Coltea - Spital Clinic
  • Singapore General Hospital
  • Tan Tock Seng Hospital
  • Hospital Universitario Central de Asturias
  • Institut Hospital del Mar d'Investigacions Mèdiques
  • Hospital Universitari Vall d'Hebrón
  • Hospital Germans Trias i Pujol
  • Hospital San Pedro de Alcantara
  • Institut Català d'Oncologia Girona
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Virgen de la Victoria
  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitario La Fe
  • Hospital de Día Quirónsalud Zaragoza
  • Karolinska Universitetssjukhuset Solna
  • Sahlgrenska Universitetssjukhuset
  • Uddevalla Sjukhus
  • Chiayi Chang Gung Memorial Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital - Linkou Branch
  • United Lincolnshire Hospitals NHS Trust
  • University Hospitals Bristol NHS Foundation Trust
  • University College London Hospitals NHS Foundation Trust
  • Guy's and Saint Thomas' NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • University Hospital Southampton NHS Foundation Trust
  • NHS Lanarkshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Momelotinib

Danazol

Arm Description

Participants will receive momelotinib plus placebo to match danazol

Participants will receive danazol plus placebo to match momelotinib

Outcomes

Primary Outcome Measures

Total Symptom Score (TSS) Response Rate at Week 24
TSS response rate was measured using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of myelofibrosis (MF) identified through existing patient- 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. MFSAF TSS v4.0 response rate was defined as the percentage of participants with a ≥ 50% reduction from baseline in mean MFSAF TSS over the consecutive 28-day period immediately before the end of Week 24. A reduction from baseline corresponded to a lessening of MF symptoms.

Secondary Outcome Measures

Number of Participants With Transfusion Independence (TI) at Week 24
TI status was defined as not requiring red blood cell or whole blood transfusion (except in the case of clinically overt bleeding) for ≥12 weeks, with all hemoglobin levels during the terminal ≥ 12 week interval of ≥ 8 g/dL (except in the case of clinically overt bleeding).
Splenic Response Rate (SRR) of ≥ 25% at Week 24
Measured as the percentage of participants who had splenic response at Week 24. A splenic response was defined as a reduction in spleen volume of ≥ 25% from baseline.
SRR of ≥ 35% at Week 24
Measured as the percentage of participants who had splenic response at Week 24. A splenic response was defined as a reduction in spleen volume of ≥ 35% from baseline.
Change in MFSAF TSS From Baseline at Week 24
Defined as the change from baseline in mean MFSAF TSS over the 28 days immediately before the end of 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 patient- 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.
Rate of No Transfusion at Week 24
Defined as the percentage of participants with zero red blood cell or whole blood units transfused during the 24-week randomized treatment period.
Duration of the End of Week 24 MFSAF TSS Response
For participants who achieved a Week 24 TSS response, the duration of response was defined as the number of days from the start of the initial 28-day period (during the 24-Week Randomized Treatment Period), in which the 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 participant's TSS equaled or exceeded their baseline value. TSS will be assessed during the last 7 days (± 7 days) of each month during the open label extended treatment period until Week 48.
Average Duration of TI at Week 24
Measured in participants who achieved TI status at Week 24. TI status was defined as the number of days from the first day of a period of at least 12 weeks, during which a participant received no transfusions and had no hemoglobin < 8 g/dL (except in the case of clinically overt bleeding), to the first red blood cell or whole blood transfusion or hemoglobin level < 8 g/dL (again, except in the case of clinically overt bleeding) (assessed until the end of Week 48).
Cumulative Transfusion Risk at Week 24
Cumulative transfusion risk was calculated as the estimated mean cumulative number of red blood cell or whole blood units transfused during the randomized treatment period.
Transfusion Dependence (TD) Rate at Week 24
Defined as the percentage of participants with TD. 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.
Number of Participants With a Hemoglobin Response
Hemoglobin response was defined as increases of ≥1, ≥1.5, or ≥2 g/dL from baseline in hemoglobin over the 24-week randomized treatment period and the last 12 weeks of the period with any hemoglobin values within 4 weeks after a transfusion excluded. Assessed in all participants and in the subset of participants who were TI at baseline.
Percentage 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.
Average Duration of TI at Week 24 in Baseline TD Participants
Measured in participants who achieved TI status at Week 24 who were TD at baseline. TI status was defined as the number of days from the first day of a period of at least 12 weeks, during which a participant received no transfusions and had no hemoglobin < 8 g/dL (except in the case of clinically overt bleeding), to the first red blood cell or whole blood transfusion or hemoglobin level < 8 g/dL (again, except in the case of clinically overt bleeding) (assessed until the end of Week 48).
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as 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. A serious AE (SAE) was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, resulted in in a congenital anomaly/ birth defect in the offspring of an exposed female participant or offspring of a female partner of a male participant, or required medical or surgical intervention. AEs at Grade 3 (severe) or above based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, relationship of AEs to study drug, serious AEs and AEs leading to discontinuation of study drug were reported. Any clinically significant changes in laboratory tests and spleen measurements were also recorded as AEs.
Overall Survival (OS)
Defined as the interval from the first study drug dosing date to death from any cause.
Leukemia-free Survival (LFS)
Defined as the interval from the first study drug dosing date to any evidence of leukemic transformation and/or death.
Change From Baseline in Disease-related Fatigue as Assessed by MFSAF v4.0
The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing patient- 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 total possible range of scores was 0 to 70, with higher scores corresponding to more severe MF symptoms. An increase in score from baseline indicated a worsening of MF symptoms, and a decrease in score from baseline indicated an improvement in MF symptoms.
Change From Baseline in Cancer-related Fatigue as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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". Raw scores were 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.
Change From Baseline in Physical Function Score as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b
The PROMIS Physical Function Short Form 10b consists of 14 questions; each with a 5-point response. The PROMIS short form assesses the self-reported capability of a participant rather than actual performance of physical activities. This includes the 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). The 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.

Full Information

First Posted
November 20, 2019
Last Updated
December 1, 2022
Sponsor
Sierra Oncology LLC - a GSK company
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1. Study Identification

Unique Protocol Identification Number
NCT04173494
Brief Title
A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Patients (MOMENTUM)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sierra Oncology LLC - a GSK company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.
Detailed Description
MOMENTUM Contact Email: GSKClinicalSupportHD@gsk.com

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
Keywords
Myelofibrosis, JAK inhibitor, Danazol, Momelotinib, Functional Iron deficiency, ACVR1, Anemia, Transfusion, Hepcidin, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Momelotinib
Arm Type
Experimental
Arm Description
Participants will receive momelotinib plus placebo to match danazol
Arm Title
Danazol
Arm Type
Active Comparator
Arm Description
Participants will receive danazol plus placebo to match momelotinib
Intervention Type
Drug
Intervention Name(s)
Momelotinib
Other Intervention Name(s)
MMB, GS-0387, CYT387
Intervention Description
Momelotinib tablets will be self-administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Danazol
Other Intervention Name(s)
Danocrine
Intervention Description
Danazol capsules will be self-administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match momelotinib
Intervention Description
Momelotinib placebo tablets will be self-administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match danazol
Intervention Description
Danazol placebo capsules will be self-administered orally twice daily
Primary Outcome Measure Information:
Title
Total Symptom Score (TSS) Response Rate at Week 24
Description
TSS response rate was measured using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of myelofibrosis (MF) identified through existing patient- 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. MFSAF TSS v4.0 response rate was defined as the percentage of participants with a ≥ 50% reduction from baseline in mean MFSAF TSS over the consecutive 28-day period immediately before the end of Week 24. A reduction from baseline corresponded to a lessening of MF symptoms.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Number of Participants With Transfusion Independence (TI) at Week 24
Description
TI status was defined as not requiring red blood cell or whole blood transfusion (except in the case of clinically overt bleeding) for ≥12 weeks, with all hemoglobin levels during the terminal ≥ 12 week interval of ≥ 8 g/dL (except in the case of clinically overt bleeding).
Time Frame
Week 24
Title
Splenic Response Rate (SRR) of ≥ 25% at Week 24
Description
Measured as the percentage of participants who had splenic response at Week 24. A splenic response was defined as a reduction in spleen volume of ≥ 25% from baseline.
Time Frame
Baseline and Week 24
Title
SRR of ≥ 35% at Week 24
Description
Measured as the percentage of participants who had splenic response at Week 24. A splenic response was defined as a reduction in spleen volume of ≥ 35% from baseline.
Time Frame
Baseline and Week 24
Title
Change in MFSAF TSS From Baseline at Week 24
Description
Defined as the change from baseline in mean MFSAF TSS over the 28 days immediately before the end of 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 patient- 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.
Time Frame
Baseline and Week 24
Title
Rate of No Transfusion at Week 24
Description
Defined as the percentage of participants with zero red blood cell or whole blood units transfused during the 24-week randomized treatment period.
Time Frame
Week 24
Title
Duration of the End of Week 24 MFSAF TSS Response
Description
For participants who achieved a Week 24 TSS response, the duration of response was defined as the number of days from the start of the initial 28-day period (during the 24-Week Randomized Treatment Period), in which the 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 participant's TSS equaled or exceeded their baseline value. TSS will be assessed during the last 7 days (± 7 days) of each month during the open label extended treatment period until Week 48.
Time Frame
Week 48
Title
Average Duration of TI at Week 24
Description
Measured in participants who achieved TI status at Week 24. TI status was defined as the number of days from the first day of a period of at least 12 weeks, during which a participant received no transfusions and had no hemoglobin < 8 g/dL (except in the case of clinically overt bleeding), to the first red blood cell or whole blood transfusion or hemoglobin level < 8 g/dL (again, except in the case of clinically overt bleeding) (assessed until the end of Week 48).
Time Frame
Week 48
Title
Cumulative Transfusion Risk at Week 24
Description
Cumulative transfusion risk was calculated as the estimated mean cumulative number of red blood cell or whole blood units transfused during the randomized treatment period.
Time Frame
Week 24
Title
Transfusion Dependence (TD) Rate at Week 24
Description
Defined as the percentage of participants with TD. 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.
Time Frame
Week 24
Title
Number of Participants With a Hemoglobin Response
Description
Hemoglobin response was defined as increases of ≥1, ≥1.5, or ≥2 g/dL from baseline in hemoglobin over the 24-week randomized treatment period and the last 12 weeks of the period with any hemoglobin values within 4 weeks after a transfusion excluded. Assessed in all participants and in the subset of participants who were TI at baseline.
Time Frame
Baseline and Week 24
Title
Percentage of Baseline TD Participants With TI Status at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Average Duration of TI at Week 24 in Baseline TD Participants
Description
Measured in participants who achieved TI status at Week 24 who were TD at baseline. TI status was defined as the number of days from the first day of a period of at least 12 weeks, during which a participant received no transfusions and had no hemoglobin < 8 g/dL (except in the case of clinically overt bleeding), to the first red blood cell or whole blood transfusion or hemoglobin level < 8 g/dL (again, except in the case of clinically overt bleeding) (assessed until the end of Week 48).
Time Frame
Baseline and Week 48
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
An AE was defined as 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. A serious AE (SAE) was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, resulted in in a congenital anomaly/ birth defect in the offspring of an exposed female participant or offspring of a female partner of a male participant, or required medical or surgical intervention. AEs at Grade 3 (severe) or above based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, relationship of AEs to study drug, serious AEs and AEs leading to discontinuation of study drug were reported. Any clinically significant changes in laboratory tests and spleen measurements were also recorded as AEs.
Time Frame
Day 1 to Week 204
Title
Overall Survival (OS)
Description
Defined as the interval from the first study drug dosing date to death from any cause.
Time Frame
Day 1 to Week 204
Title
Leukemia-free Survival (LFS)
Description
Defined as the interval from the first study drug dosing date to any evidence of leukemic transformation and/or death.
Time Frame
Day 1 to Week 204
Title
Change From Baseline in Disease-related Fatigue as Assessed by MFSAF v4.0
Description
The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing patient- 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 total possible range of scores was 0 to 70, with higher scores corresponding to more severe MF symptoms. An increase in score from baseline indicated a worsening of MF symptoms, and a decrease in score from baseline indicated an improvement in MF symptoms.
Time Frame
Baseline to Week 48
Title
Change From Baseline in Cancer-related Fatigue as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Description
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". Raw scores were 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.
Time Frame
Baseline to Week 96
Title
Change From Baseline in Physical Function Score as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b
Description
The PROMIS Physical Function Short Form 10b consists of 14 questions; each with a 5-point response. The PROMIS short form assesses the self-reported capability of a participant rather than actual performance of physical activities. This includes the 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). The 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.
Time Frame
Baseline to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years. Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-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 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 cm, below the left costal margin, or with volume ≥ 450 cm³ on imaging (ultrasound, MRI or CT are acceptable), assessed during Screening at any point prior to Randomization. High risk, intermediate-2, or intermediate-1 risk MF as defined by DIPSS, or DIPSS-plus. No allogeneic stem cell transplant planned. Acceptable laboratory assessments: Absolute neutrophil count (ANC) ≥ 0.75 × 10E9/L. Platelet count (PLT) ≥ 25 × 10E9/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 × 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 mL/min according to Cockcroft-Gault. Direct bilirubin ≤ 2.0 × ULN. Exclusion Criteria: 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 ng/mL. Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI 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 (subjects 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. QTcF interval > 500 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. Subjects 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srdan Verstovsek, M.D., Ph.D.
Organizational Affiliation
Department of Leukemia, The University of Texas MD Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruben Mesa
Organizational Affiliation
UT Health San Antonio Cancer Center, San Antonio, TX, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
91011
Country
United States
Facility Name
American Institute of Research - Whittier
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
University of Colorado Hospital Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwest Oncology & Hematology - Rolling Meadows
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Washington University School of Medicine in Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Columbia University Irving Medical Center - Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic - Richard E. Jacobs Health Center
City
Avon
State/Province
Ohio
ZIP/Postal Code
44011
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Canberra Region Cancer Centre
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Calvary Mater Newcastle Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Perth Radiological Clinic - Magnetic Resonance Centre
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Ordensklinikum Linz Elisabethinen
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
State/Province
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Oberösterreichische Gesundheitsholding GmbH
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Hôpital Erasme
City
Bruxelles
State/Province
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Grand Hôpital de Charleroi - Notre Dame
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Ziekenhuis Netwerk Antwerpen Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Hospital St. Ivan Rilski
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital For Active Treatment Aleksandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
National Specialized Hospital for Active Treatment of Haematologic Diseases
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Saint Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre - Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Institute of the McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
Facility Name
Hôpital de l'Enfant-Jésus
City
Québec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Fakultni Nemocnice Brno
City
Brno
State/Province
Jihormoravsky Kraj
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Herlev Hospital
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Aalborg Universitetshospital - Syd
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Sjællands Universitetshospital - Roskilde
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Hôpital Haut-Lévêque
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33604
Country
France
Facility Name
Hospital Center University Of Caen Normandie
City
Caen
State/Province
Basse-Normandie
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75571
Country
France
Facility Name
Centre Hospitalier Universitaire Limoges
City
Limoges
State/Province
Limousin
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier De Lens
City
Lens
State/Province
Nord Pas-Des-Calais
ZIP/Postal Code
62307
Country
France
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
State/Province
Pays De La Loire
ZIP/Postal Code
72037
Country
France
Facility Name
Centre Hospitalier Universitaire Amiens-Picardie - Site Sud
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Facility Name
Hôpital l'Archet
City
Nice
State/Province
Provence-Alpes-Côte d'Azur
ZIP/Postal Code
06200
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Bénite
State/Province
Rhone-Alps
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hosptitalier Universitaire Angers
City
Angers
ZIP/Postal Code
49 933
Country
France
Facility Name
Hôpital Saint-Vincent De Paul - Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital De La Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Emile Muller
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Centre Hospitalier Universitaire Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Universitätsklinikum Aachen
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32429
Country
Germany
Facility Name
Universitätsklinikum Halle
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thuringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szent Borbála Kórház
City
Tatabánya
State/Province
Komárom-Esztergom
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely
City
Budapest
State/Province
Pest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
City
Nyíregyháza
State/Province
Szabolcs-Szatmár-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatókórház Szombathely
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Győr
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Yitzhak Shamir Medical Center
City
Be'er Ya'aqov
State/Province
Central District
ZIP/Postal Code
7030000
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
State/Province
Haifa District
ZIP/Postal Code
31048
Country
Israel
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
State/Province
Jerusalem District
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Western Galilee Hospital-Nahariya
City
Nahariya
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petah tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Firenze
State/Province
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
State/Province
Forli-Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
City
Pesaro
State/Province
Pesaro E Urbino
ZIP/Postal Code
61121
Country
Italy
Facility Name
IRCCS Centro di Riferimento Oncologico di Basilicata
City
Rionero In Vulture
State/Province
Potenza
ZIP/Postal Code
85028
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
City
Torino
State/Province
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera Ordine Mauriziano di Torino
City
Torino
State/Province
Turin
ZIP/Postal Code
10128
Country
Italy
Facility Name
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Umberto I - Policlinico di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
20123
Country
Italy
Facility Name
Presidio Ospedaliero Universitario Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Ospedale Policlinico Giambattista Rossi Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Daegu Gwang'yeogsi
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Instytut Hematologii I Transfuzjologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Alvamed Zakład Specjalistycznej Opieki Zdrowotnej
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-401
Country
Poland
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Szpital Wojewódzki w Opolu
City
Opole
State/Province
Opolskie
ZIP/Postal Code
45-064
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne w Gdańsku
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Silesian Healthy Blood Clinic
City
Chorzów
State/Province
Salskie
ZIP/Postal Code
41-503
Country
Poland
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Spitalul Filantropia - Craiova
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200143
Country
Romania
Facility Name
Institutul Regional De Oncologie Iasi
City
Iaşi
State/Province
Iasi County
ZIP/Postal Code
700483
Country
Romania
Facility Name
Spitalul Clinic Judetean De Urgenta Târgu Mureș
City
Târgu-Mureş
State/Province
Mureș
ZIP/Postal Code
540136
Country
Romania
Facility Name
Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov
City
Braşov
ZIP/Postal Code
500366
Country
Romania
Facility Name
Coltea - Spital Clinic
City
Bucharest
ZIP/Postal Code
030 171
Country
Romania
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Institut Hospital del Mar d'Investigacions Mèdiques
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Institut Català d'Oncologia Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital de Día Quirónsalud Zaragoza
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Facility Name
Karolinska Universitetssjukhuset Solna
City
Solna
State/Province
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
State/Province
Västra Götalands Län
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Uddevalla Sjukhus
City
Uddevalla
ZIP/Postal Code
45153
Country
Sweden
Facility Name
Chiayi Chang Gung Memorial Hospital
City
Puzi City
State/Province
Chaiyi
ZIP/Postal Code
613
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
United Lincolnshire Hospitals NHS Trust
City
Boston
State/Province
England
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's and Saint Thomas' NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
State/Province
England
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
NHS Lanarkshire
City
Airdrie
State/Province
Scotland
ZIP/Postal Code
ML6 0JS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36164014
Citation
Gerds A, Verstovsek S, Vannucchi A, Al-Ali HK, Lavie D, Kuykendall A, Grosicki S, Iurlo A, Goh YT, Lazaroiu M, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Donahue R, Kawashima J, Mesa R. MPN-483 Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S340. doi: 10.1016/S2152-2650(22)01464-1.
Results Reference
derived

Learn more about this trial

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

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