TriangleNCT04173494 · CITED IN SOURCE DOCUMENTS
A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2023-11-01
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of \>= 10 at screening, and be anemic with hemoglobin (Hgb) \< 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Total Symptom Score (TSS) Response Rate at Week 24
Percentage of Participants With Transfusion Independence (TI) at Week 24
Splenic Response Rate (SRR) of >=25% at Week 24
Change From Baseline in MFSAF TSS at Week 24
Splenic Response Rate (SRR) of >= 35% at Week 24
Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks
Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks
Duration of MFSAF TSS Response
Duration of TI Response
Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks
Percentage of Participants With Transfusion Dependence (TD) Status at Week 24
Percentage of Participants With a Hemoglobin Response
Number of Baseline TD Participants With TI Status at Week 24
Duration of TI in Baseline TD Participants
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to Week 24
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- From Week 24 to a Maximum of 151 Weeks
Overall Survival (OS)
Leukemia-free Survival (LFS)
Change From Baseline in Disease-related Fatigue as Assessed by MFSAF TSS v4.0 at Week 24
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
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
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Age \>= 18 years. * Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post- polycythemia vera/essential thrombocythemia (PV/ET) MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT criteria). * Symptomatic, defined as a TSS of \>= 10 units assessed by a single MFSAF v4.0 assessment during Screening prior to Baseline period (Day BL1). * Anemic, defined as a Hgb \< 10 g/dL in Screening/Baseline period. * Previously treated with an approved JAK inhibitor for PMF or Post-PV/ET MF for \>= 90 days, or \>= 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of \>= 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma. * Baseline splenomegaly, defined as having a palpable spleen at \>= 5 centimeter (cm), below the left costal margin, or with volume \>= 450 cubic centimeter (cm\^3) on imaging (ultrasound, magnetic resonance imaging \[MRI\] or computed tomography \[CT\] are acceptable), assessed during Screening at any point prior to Randomization. * High risk, intermediate-2, or intermediate-1 risk MF as defined by Dynamic International Prognostic Scoring System (DIPSS), or DIPSS-plus. * No allogeneic stem cell transplant planned. * Acceptable laboratory assessments: 1. Absolute neutrophil count (ANC) \>= 0.75 × 10\^9/Liter (L). 2. Platelet count (PLT) \>= 25 × 10\^9/L (without requirement for platelet transfusion). 3. Peripheral blast count \< 10%. 4. 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). 5. Calculated creatinine clearance (CCr) \>= 30 milliliter per minute (mL/min) according to Cockcroft-Gault. 6. Direct bilirubin \<= 2.0 × ULN. Exclusion Criteria: * 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. * 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): 1. 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). 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. QT Interval Corrected Using Fridericia's Formula (QTcF) interval \> 500 millisecond (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. * 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive momelotinib plus placebo to match danazol
- intervention Names
- Drug: Momelotinib
- Drug: Placebo to match danazol
- label
- Momelotinib
- type
- EXPERIMENTAL
- description
- Participants will receive danazol plus placebo to match momelotinib
- intervention Names
- Drug: Danazol
- Drug: Placebo to match momelotinib
- label
- Danazol
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Momelotinib
- description
- Momelotinib tablets will be self-administered orally once daily
- name
- Momelotinib
- other Names
- MMB, GS-0387, CYT387
- type
- DRUG
- arm Group Labels
- Momelotinib
- description
- Danazol placebo capsules will be self-administered orally twice daily
- name
- Placebo to match danazol
- type
- DRUG
- arm Group Labels
- Danazol
- description
- Danazol capsules will be self-administered orally twice daily
- name
- Danazol
- other Names
- Danocrine
- type
- DRUG
- arm Group Labels
- Danazol
- description
- Momelotinib placebo tablets will be self-administered orally once daily
- name
- Placebo to match momelotinib
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- masking Description
- During the 24 week randomized treatment phase of the study, participants, investigators and sponsor and relevant vendor personnel (with the exception of specified unblinded personnel, for example clinical supply) will remain blinded to the participant's treatment assignment and to aggregate data that may lead to inadvertent unblinding. Participants who continue treatment with momelotinib or danazol after Week 24 in the extended treatment phase will receive unblinded treatment.
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 195
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Total Symptom Score (TSS) Response Rate at Week 24
- time Frame
- Baseline and Week 24
- secondary Outcomes
- description
- 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.
- measure
- Percentage of Participants With Transfusion Independence (TI) at Week 24
- time Frame
- Week 24
- description
- 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.
- measure
- Splenic Response Rate (SRR) of >=25% at Week 24
- time Frame
- Baseline and Week 24
- description
- 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.
- measure
- Change From Baseline in MFSAF TSS at Week 24
- time Frame
- Baseline and Week 24
- description
- 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.
- measure
- Splenic Response Rate (SRR) of >= 35% at Week 24
- time Frame
- Baseline and Week 24
- description
- Percentage of participants with zero RBC units transfused over 24-weeks were reported.
- measure
- Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks
- time Frame
- Up to 24 weeks
- description
- Percentage of participants with \<=4 RBC units transfused over 24-weeks were reported.
- measure
- Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks
- time Frame
- Up to 24 weeks
- description
- 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.
- measure
- Duration of MFSAF TSS Response
- time Frame
- Up to a maximum of 151 weeks
- description
- 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).
- measure
- Duration of TI Response
- time Frame
- Up to a maximum of 151 weeks
- description
- Cumulative transfusion risk was calculated as the estimated mean cumulative number of whole blood units transfused during the study.
- measure
- Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks
- time Frame
- Up to Week 24
- description
- 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.
- measure
- Percentage of Participants With Transfusion Dependence (TD) Status at Week 24
- time Frame
- Week 24
- description
- 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.
- measure
- Percentage of Participants With a Hemoglobin Response
- time Frame
- Baseline and 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.
- measure
- Number of Baseline TD Participants With TI Status at Week 24
- time Frame
- Week 24
Full 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 participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of \>= 10 at screening, and be anemic with hemoglobin (Hgb) \< 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.
- detailed Description
- MOMENTUM Contact Email: GSKClinicalSupportHD@gsk.com
Source references
- references
- citation
- 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.
- pmid
- 42452788
- type
- DERIVED
- citation
- 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.
- pmid
- 41958363
- type
- DERIVED
- citation
- Yoon SS, Chen CC, Lee SE, Chang H, Cheong JW, Hou HA, Lee WS, Lim SN, Moon JH, Ong KH, Dai Y, Liu C, Kawashima J, Goh YT. Efficacy and safety of momelotinib in Janus kinase inhibitor-experienced Asian patients with myelofibrosis and anemia. Int J Hematol. 2025 Nov;122(5):660-670. doi: 10.1007/s12185-025-04037-6. Epub 2025 Jul 21.
- pmid
- 40691344
- type
- DERIVED
- citation
- 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.
- pmid
- 40535755
- type
- DERIVED
- citation
- 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.
- pmid
- 39516087
- type
- DERIVED
- citation
- 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.
- pmid
- 37517413
- type
- DERIVED
- citation
- 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.
- pmid
- 37042865
- type
- DERIVED
- citation
- 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.
- pmid
- 36709073
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-50a9feb4e49b45960450
- requested nct id
- NCT04173494
- primary nct id
- NCT04173494
- source kind
- fda_spl_label
- source record id
- 3921e23f-5c82-4e00-9611-f017ff57c06e
- source file sha256
- d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
- payload sha256
- a4b4182a5561ba0e861b3107355ca011999eee73c898d59cf89f4c631fa6302c
- payload
- application numbers
- NDA216873
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-50a9feb4e49b45960450
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT04173494
- occurrences
- context exact
- ge of OJJAARA 200 mg once daily. Eligible patients had baseline platelet count of ≥25 × 10 9 /L in MOMENTUM and ≥50 × 10 9 /L in SIMPLIFY‑1. MOMENTUM MOMENTUM (NCT04173494) was a double‑blind, 2:1 randomized, active‑controlled trial in 195 symptomatic and anemic adults with MF who had previously received an approved JAK inhibitor
- end
- 621
- exact text
- NCT04173494
- start
- 610
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00200.json
- source file sha256
- d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
- source json pointer
- /results/9/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 3921e23f-5c82-4e00-9611-f017ff57c06e
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- e56ad5d40cb428241332923fd9e0bbeaa60b648c6b64ead7ddd1cc1023730883
- spl effective time
- 20260720
- spl set id
- 4a672fd1-eb7b-4aa9-9b23-845e4b5dc400
Preserved source evidence · Not medical advice