Trial · NCT02101268
Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF
NCT02101268, Phase 3, Completed, Sierra Oncology LLC - a GSK company; results first posted 2023-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF. Trials, record NCT02101268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02101268
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF
- NCT number
- NCT02101268
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 156 participants, actual
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Conditions
- Primary Myelofibrosis (PMF), Post-polycythemia Vera (Post-PV), Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
- Interventions
- Momelotinib, Best Available Therapy (BAT)
- First posted
- 2014-04-02
- Last updated
- 2023-05-23
- Other registries' IDs
- eudract:2013-005007-13
- Results first posted
- 2023-05-23
- Limitations and caveats
- Best available therapy could also include the approved JAK inhibitor, ruxolitinib, and 88% of participants in the BAT arm continued to receive ruxolitinib.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Splenic Response Rate at Week 24 | Week 24 | Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT. |
| Secondary | Total Symptom Score (TSS) Response Rate at Week 24 | Week 24 | Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available. The modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of TSS in this study was based on 7 of these items, (0-70) excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 corresponding to "Worst Imaginable." |
| Secondary | Rate of Red Blood Cell (RBC) Transfusion in the Randomized Treatment Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) | Baseline to Week 24 | Rate of RBC transfusion is defined as the average number of RBC units transfused not associated with clinically overt bleeding per subject-month during the randomized treatment Phase. |
| Secondary | RBC Transfusion Independence Rate at Week 24, (Defined as Absence of RBC Transfusions and no Hemoglobin Level Below 8 g/dL in the 12 Weeks Prior to Week 24, Excluding Cases Associated With Clinically Overt Bleeding) | Week 24 | RBC transfusion independence rate is the percentage of participants who achieved transfusion independence at Week 24 (responders). RBC transfusion independence is defined as absence of RBC transfusions and no hemoglobin level below 8 g/dL in the 12 weeks prior to Week 24, excluding cases associated with clinically overt bleeding. Transfusion dependence, (non-responder) is defined as at least 4 units of RBC transfusion, or a Hgb level below 8 g/dL, in the 8 weeks prior to week 24. Methods used to assess this outcome measure include collection and recording of any instances of RBC transfusions and collection and recording of any local or central lab hemoglobin measurements |
| Secondary | RBC Transfusion Dependence Rate at Week 24 | Week 24 | RBC transfusion dependence is the percentage of participants who are transfusion dependent at Week 24, defined as at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in the 8 weeks prior to Week 24, excluding cases associated with clinically overt bleeding. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Splenic Response Rate at Week 24 | Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Symptom Score (TSS) Response Rate at Week 24 | Week 24 | TSS rate analysis at Week 24 only included participants with TSS \> 0 at baseline or with TSS = 0 at baseline but with TSS \> 0 or missing at Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Red Blood Cell (RBC) Transfusion in the Randomized Treatment Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) | Baseline to Week 24 | units/month | MEDIAN | |
| SECONDARY | RBC Transfusion Independence Rate at Week 24, (Defined as Absence of RBC Transfusions and no Hemoglobin Level Below 8 g/dL in the 12 Weeks Prior to Week 24, Excluding Cases Associated With Clinically Overt Bleeding) | Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | RBC Transfusion Dependence Rate at Week 24 | Week 24 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Splenic Response Rate at Week 24 | Momelotinib (MMB) | Responder | 7 | Participants | |
| Splenic Response Rate at Week 24 | Best Available Therapy (BAT) | Responder | 3 | Participants | |
| Splenic Response Rate at Week 24 | Momelotinib (MMB) | Nonresponder | 97 | Participants | |
| Splenic Response Rate at Week 24 | Best Available Therapy (BAT) | Nonresponder | 49 | Participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | Momelotinib (MMB) | Responder | 27 | Participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | Best Available Therapy (BAT) | Responder | 3 | Participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | Momelotinib (MMB) | Nonresponder | 76 | Participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | Best Available Therapy (BAT) | Nonresponder | 48 | Participants | |
| Rate of Red Blood Cell (RBC) Transfusion in the Randomized Treatment Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) | Momelotinib (MMB) | 0.5 | Inter-Quartile Range 0.0 to 2.4 | units/month | |
| Rate of Red Blood Cell (RBC) Transfusion in the Randomized Treatment Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) | Best Available Therapy (BAT) | 1.2 | Inter-Quartile Range 0.0 to 2.8 | units/month |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Treatment Phase | STARTED | Momelotinib (MMB) | 104 | |
| Randomized Treatment Phase | STARTED | Best Available Therapy (BAT) | 52 | |
| Randomized Treatment Phase | STARTED | MMB to MMB | 0 | |
| Randomized Treatment Phase | STARTED | BAT to MMB | 0 | |
| Randomized Treatment Phase | COMPLETED | Momelotinib (MMB) | 77 | |
| Randomized Treatment Phase | COMPLETED | Best Available Therapy (BAT) | 41 | |
| Randomized Treatment Phase | COMPLETED | MMB to MMB | 0 | |
| Randomized Treatment Phase | COMPLETED | BAT to MMB | 0 | |
| Randomized Treatment Phase | NOT COMPLETED | Momelotinib (MMB) | 27 | |
| Randomized Treatment Phase | NOT COMPLETED | Best Available Therapy (BAT) | 11 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events788
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 | Diarrhoea | Gastrointestinal disorders | Momelotinib (MMB) | 33 | 104 | |
| other | Diarrhoea | Gastrointestinal disorders | Best Available Therapy (BAT) | 8 | 52 | |
| other | Diarrhoea | Gastrointestinal disorders | MMB to MMB | 19 | 64 | |
| other | Diarrhoea | Gastrointestinal disorders | BAT to MMB | 10 | 40 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Momelotinib (MMB) | 18 | 104 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Best Available Therapy (BAT) | 6 | 52 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | MMB to MMB | 17 | 64 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | BAT to MMB | 8 | 40 | |
| other | Asthenia | General disorders | Momelotinib (MMB) | 20 | 104 | |
| other | Asthenia | General disorders | Best Available Therapy (BAT) | 11 | 52 |
1 to 10 of 788Source ClinicalTrials.gov
See all 788 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Momelotinib (MMB) | 8 | 104 |
| Total, all-cause mortality | Best Available Therapy (BAT) | 5 | 52 |
| Total, all-cause mortality | MMB to MMB | 29 | 64 |
| Total, all-cause mortality | BAT to MMB | 18 | 40 |
| Total, other adverse events | Momelotinib (MMB) | 99 | 104 |
| Total, other adverse events | Best Available Therapy (BAT) | 46 | 52 |
| Total, other adverse events | MMB to MMB | 63 | 64 |
| Total, other adverse events | BAT to MMB | 40 | 40 |
| Total, serious adverse events | Momelotinib (MMB) | 37 | 104 |
| Total, serious adverse events | Best Available Therapy (BAT) | 12 | 52 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02101268
GET https://conductscience.org/api/trials/v1/NCT02101268/flow?page=2