Trial · NCT04173494
A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
NCT04173494, Phase 3, Completed, Sierra Oncology LLC - a GSK company; results first posted 2022-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM). Trials, record NCT04173494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04173494
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
- NCT number
- NCT04173494
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 195 participants, actual
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Conditions
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Interventions
- Momelotinib, Placebo to match danazol, Danazol, Placebo to match momelotinib
- First posted
- 2019-11-22
- Last updated
- 2023-11-01
- Results first posted
- 2022-12-22
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Symptom Score (TSS) Response Rate at Week 24 | Baseline and Week 24 | Myelofibrosis Symptom Assessment Form (MFSAF) TSS version (v) 4.0 response rate was defined as percentage of participants with a \>= 50 percent (%) reduction from Baseline in mean MFSAF TSS over consecutive 28-day period immediately before end of Week 24. TSS response rate was measured using MFSAF v4.0. MFSAF v4.0 comprises 7 domains representing 7 most relevant symptoms of myelofibrosis (MF) identified through existing participant and clinician-based evidence: fatigue,night sweats,pruritus,abdominal discomfort,pain under left ribs,early satietyand bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0(absent) to 10(worst imaginable). The MFSAF TSS was calculated as sum of scores of 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date. |
| Secondary | Percentage of Participants With Transfusion Independence (TI) at Week 24 | Week 24 | TI status was defined as not receiving red blood cell (RBC) or whole blood transfusion for \>=12 weeks, with no hemoglobin (Hgb) level \< 8 grams per deciliter (g/dL) during the same interval. Percentage of participants with TI have been presented. |
| Secondary | Splenic Response Rate (SRR) of >=25% at Week 24 | Baseline and Week 24 | Splenic response rate (SRR) is defined as the percentage of participants who have reduction in spleen volume of \>=25% from Baseline at the end of Week 24. Baseline was the last assessment done before or on the day of first dose date. |
| Secondary | Change From Baseline in MFSAF TSS at Week 24 | Baseline and Week 24 | TSS was measured using the MFSAF v4.0. The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing participant and clinician-based evidence: fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, and bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). The MFSAF TSS was calculated as the sum of scores of the 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value. |
| Secondary | Splenic Response Rate (SRR) of >= 35% at Week 24 | Baseline and Week 24 | Splenic response rate (SRR) is defined as the percentage of participants who have reduction in spleen volume of \>=35 % from Baseline at the end of Week 24. Baseline was the last assessment done before or on the day of first dose date. |
| Secondary | Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks | Up to 24 weeks | Percentage of participants with zero RBC units transfused over 24-weeks were reported. |
| Secondary | Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks | Up to 24 weeks | Percentage of participants with \<=4 RBC units transfused over 24-weeks were reported. |
| Secondary | Duration of MFSAF TSS Response | Up to a maximum of 151 weeks | 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. |
| Secondary | Duration of TI Response | Up to a maximum of 151 weeks | 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). |
| Secondary | Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks | Up to Week 24 | Cumulative transfusion risk was calculated as the estimated mean cumulative number of whole blood units transfused during the study. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Symptom Score (TSS) Response Rate at Week 24 | Baseline and Week 24 | Measured in the Intent-To-Treat (ITT) Analysis Set, which included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Transfusion Independence (TI) at Week 24 | Week 24 | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Splenic Response Rate (SRR) of >=25% at Week 24 | Baseline and Week 24 | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in MFSAF TSS at Week 24 | Baseline and Week 24 | ITT Analysis Set. Only those participants with data available at specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Splenic Response Rate (SRR) of >= 35% at Week 24 | Baseline and Week 24 | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks | Up to 24 weeks | ITT Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks | Up to 24 weeks | ITT Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Duration of MFSAF TSS Response | Up to a maximum of 151 weeks | ITT Analysis Set. Only those participants with data available at specified time point were analyzed. | Days | MEDIAN |
| SECONDARY | Duration of TI Response | Up to a maximum of 151 weeks | ITT Analysis Set. Only those participants with data available at specified time point were analyzed. | Days | MEDIAN |
| SECONDARY | Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks | Up to Week 24 | ITT Analysis Set. | Whole blood units | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Symptom Score (TSS) Response Rate at Week 24 | MMB 200 mg QD + Placebo | 24.62 | 95% Confidence Interval 17.49 to 32.94 | Percentage of participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | DAN 300 mg BID + Placebo | 9.23 | 95% Confidence Interval 3.46 to 19.02 | Percentage of participants | |
| Percentage of Participants With Transfusion Independence (TI) at Week 24 | MMB 200 mg QD + Placebo | 30.0 | 95% Confidence Interval 22.28 to 38.66 | Percentage of Participants | |
| Percentage of Participants With Transfusion Independence (TI) at Week 24 | DAN 300 mg BID + Placebo | 20.00 | 95% Confidence Interval 11.10 to 31.77 | Percentage of Participants | |
| Splenic Response Rate (SRR) of >=25% at Week 24 | MMB 200 mg QD + Placebo | 39.23 | 95% Confidence Interval 30.79 to 48.18 | Percentage of Participants | |
| Splenic Response Rate (SRR) of >=25% at Week 24 | DAN 300 mg BID + Placebo | 6.15 | 95% Confidence Interval 1.70 to 15.01 | Percentage of Participants | |
| Change From Baseline in MFSAF TSS at Week 24 | MMB 200 mg QD + Placebo | -9.36 | Standard Error 1.08 | Scores on a scale | |
| Change From Baseline in MFSAF TSS at Week 24 | DAN 300 mg BID + Placebo | -3.13 | Standard Error 1.62 | Scores on a scale | |
| Splenic Response Rate (SRR) of >= 35% at Week 24 | MMB 200 mg QD + Placebo | 22.31 | 95% Confidence Interval 15.48 to 30.44 | Percentage of Participants | |
| Splenic Response Rate (SRR) of >= 35% at Week 24 | DAN 300 mg BID + Placebo | 3.08 | 95% Confidence Interval 0.37 to 10.68 | Percentage of Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized DB TP (Up to Week 24) | STARTED | MMB 200 mg Once Daily (QD) + Placebo | 130 | |
| Randomized DB TP (Up to Week 24) | STARTED | DAN 300 mg BID + Placebo | 65 | |
| Randomized DB TP (Up to Week 24) | COMPLETED | MMB 200 mg Once Daily (QD) + Placebo | 94 | |
| Randomized DB TP (Up to Week 24) | COMPLETED | DAN 300 mg BID + Placebo | 38 | |
| Randomized DB TP (Up to Week 24) | NOT COMPLETED | MMB 200 mg Once Daily (QD) + Placebo | 36 | |
| Randomized DB TP (Up to Week 24) | NOT COMPLETED | DAN 300 mg BID + Placebo | 27 | |
| Open-Label Extended TP(Weeks 24 to 151) | STARTED | MMB 200 mg Once Daily (QD) + Placebo | 93 | |
| Open-Label Extended TP(Weeks 24 to 151) | STARTED | DAN 300 mg BID + Placebo | 41 | |
| Open-Label Extended TP(Weeks 24 to 151) | COMPLETED | MMB 200 mg Once Daily (QD) + Placebo | 0 | |
| Open-Label Extended TP(Weeks 24 to 151) | COMPLETED | DAN 300 mg BID + Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events636
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period | 12 | 130 | 34 |
| other | Anaemia | Blood and lymphatic system disorders | DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period | 6 | 65 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | MMB 200 mg QD- Open-Label Extended Treatment Period | 9 | 93 | 18 |
| other | Anaemia | Blood and lymphatic system disorders | DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period | 3 | 41 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period | 7 | 130 | 11 |
| other | Neutropenia | Blood and lymphatic system disorders | DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period | 2 | 65 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | MMB 200 mg QD- Open-Label Extended Treatment Period | 5 | 93 | 9 |
| other | Neutropenia | Blood and lymphatic system disorders | DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period | 2 | 41 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period | 28 | 130 | 50 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period | 7 | 65 | 11 |
1 to 10 of 636Source ClinicalTrials.gov
See all 636 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period | 25 | 130 |
| Total, all-cause mortality | DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period | 16 | 65 |
| Total, all-cause mortality | MMB 200 mg QD- Open-Label Extended Treatment Period | 23 | 93 |
| Total, all-cause mortality | DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period | 8 | 41 |
| Total, other adverse events | MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period | 108 | 130 |
| Total, other adverse events | DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period | 55 | 65 |
| Total, other adverse events | MMB 200 mg QD- Open-Label Extended Treatment Period | 57 | 93 |
| Total, other adverse events | DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period | 28 | 41 |
| Total, serious adverse events | MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period | 45 | 130 |
| Total, serious adverse events | DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period | 26 | 65 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MMB 200 mg QD + Placebo vs DAN 300 mg BID + Placebo: Number of Baseline TD Participants With TI Status at Week 24 |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04173494
GET https://conductscience.org/api/trials/v1/NCT04173494/registered?page=2