Trial · NCT02515630
Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
NCT02515630, Phase 2, Completed, Sierra Oncology LLC - a GSK company; results first posted 2021-01-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF). Trials, record NCT02515630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02515630
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
- NCT number
- NCT02515630
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Conditions
- Primary Myelofibrosis (PMF), Post-polycythemia Vera (Post-PV) Myelofibrosis, Postessential Thrombocythemia (Post-ET) Myelofibrosis
- Interventions
- MMB
- First posted
- 2015-08-05
- Last updated
- 2023-06-18
- Results first posted
- 2021-01-20
- Limitations and caveats
Pharmacokinetics parameters were removed as an analysis endpoint in the SAP due to the sparse PK samples collection.~Change in circulating cytokine and inflammatory markers were limited to CRP as an analysis endpoint in the SAP.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Transfusion Independence Response by Week 24 | From baseline to Week 24 | The percentage of subjects who became transfusion independent for ≥ 12 weeks at any time on study. A subject was considered transfusion independent on study if no RBC transfusion occurred in any 12-week period during the 24-week treatment period. |
| Secondary | Transfusion Response Rate by Week 24 | From baseline to Week 24 | The percentage of subjects who became transfusion independent for ≥ 8 weeks, defined as no RBC transfusions for at least an 8-week period at any time on study. |
| Secondary | Splenic Response Rate at Week 24 | Measured at Week 24 | The percentage of subjects who achieved a ≥ 35% reduction in spleen volume from baseline as measured by MRI at Week 24. |
| Secondary | Response Rate in Total Symptom Score (TSS) at Week 24 | Measured at Week 24 | The percentage of subjects achieving a ≥ 50% reduction from baseline in TSS at Week 24, as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPNSAF TSS) diary. Total symptom score was assessed using the modified MPN-SAF TSS Version 2, an 8-item questionnaire developed to assess symptom burden and quality of life in patients with MPN. The modified MPN-SAF TSS contained 8 questions, 7 of which were summed to generate the score (the included questions related to tiredness, early satiety, abdominal discomfort, night sweats, itching, bone pain, and pain under the ribs on the left side). Each question is scored on a scale of 0-10, where higher numbers indicate more severe symptoms. For this study, the TSS scale ranges from 0 to 70. The questionnaire was completed daily on an electronic diary device. |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | At baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20 and 24 | Hepcidin daily change (in nM) was calculated as the predose value subtracted from the 6 hours postdose value at each study visit. Daily hepcidin change at the baseline visit was the difference between 2 values obtained 6 hours apart. No momelotinib was administered on that day. |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin | At baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20 and 24 | Median hepcidin at trough was assessed predose at each study visit. |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Serum Iron | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in serum iron, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Hemoglobin | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in hemoglobin, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in total iron binding capacity, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Reticulocytes | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in reticulocytes, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Transfusion Independence Response by Week 24 | From baseline to Week 24 | Assessed in the Safety Analysis Set, which includes all subjects who received ≥ 1 dose of momelotinib. Note that 6 subjects discontinued prior to Week 12 and could not be evaluated over the minimum period required for assessment of the endpoint (12 weeks). | percentage of subjects | NUMBER |
| SECONDARY | Transfusion Response Rate by Week 24 | From baseline to Week 24 | Assessed in the Safety Analysis Set, which includes all subjects who received ≥ 1 dose of momelotinib. Note that 3 subjects discontinued prior to Week 8 and could not be evaluated over the minimum period required for assessment of the endpoint (8 weeks). | percentage of subjects | NUMBER |
| SECONDARY | Splenic Response Rate at Week 24 | Measured at Week 24 | Assessed in the Safety Analysis Set, which includes all subjects who received ≥ 1 dose of momelotinib. Note that spleen volume at Week 24 was not available for 15 subjects. | percentage of subjects | NUMBER |
| SECONDARY | Response Rate in Total Symptom Score (TSS) at Week 24 | Measured at Week 24 | There were 3 subjects with missing TSS at baseline who were excluded from the analysis. Note that of the 38 subjects evaluated, 17 were missing Week 24 TSS assessments. | percentage of subjects | NUMBER |
| SECONDARY | Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | At baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20 and 24 | nM | MEDIAN | |
| SECONDARY | Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin | At baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20 and 24 | nM | MEDIAN | |
| SECONDARY | Change in Markers of Iron Metabolism and Anemia - Serum Iron | At Weeks 2, 4, 8, 12, 16, 20 and 24 | % Change from baseline | MEDIAN | |
| SECONDARY | Change in Markers of Iron Metabolism and Anemia - Hemoglobin | At Weeks 2, 4, 8, 12, 16, 20 and 24 | % Change in from baseline | MEDIAN | |
| SECONDARY | Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity | At Weeks 2, 4, 8, 12, 16, 20 and 24 | % Change from baseline | MEDIAN | |
| SECONDARY | Change in Markers of Iron Metabolism and Anemia - Reticulocytes | At Weeks 2, 4, 8, 12, 16, 20 and 24 | % Change from baseline | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group421
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Transfusion Independence Response by Week 24 | Total | 34.1 | 90% Confidence Interval 22.0 to 48.1 | percentage of subjects | |
| Transfusion Response Rate by Week 24 | Total | 39.0 | 90% Confidence Interval 26.2 to 53.1 | percentage of subjects | |
| Splenic Response Rate at Week 24 | Total | 12.2 | 90% Confidence Interval 4.9 to 23.9 | percentage of subjects | |
| Response Rate in Total Symptom Score (TSS) at Week 24 | Total | 15.8 | 90% Confidence Interval 7.1 to 28.8 | percentage of subjects | |
| Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | Transfusion Independence Responders | Baseline | -1.7 | Inter-Quartile Range -2.1 to 4.7 | nM |
| Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | Transfusion Independence Non-Responders | Baseline | 0.1 | Inter-Quartile Range -3.3 to 4.5 | nM |
| Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | Total | Baseline | 0.0 | Inter-Quartile Range -3.3 to 4.6 | nM |
| Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | Transfusion Independence Responders | Day 1 | -4.8 | Inter-Quartile Range -10.2 to -1.4 | nM |
| Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | Transfusion Independence Non-Responders | Day 1 | -11.2 | Inter-Quartile Range -16.0 to -5.8 | nM |
| Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | Total | Day 1 | -8.6 | Inter-Quartile Range -14.4 to -3.3 | nM |
1 to 10 of 421Source ClinicalTrials.gov
See all 421 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Momelotinib (MMB) | 41 | |
| Overall Study | COMPLETED | Momelotinib (MMB) | 25 | |
| Overall Study | NOT COMPLETED | Momelotinib (MMB) | 16 |
Source ClinicalTrials.gov
Adverse events49
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) | 10 | 41 | |
| other | Nausea | Gastrointestinal disorders | Momelotinib (MMB) | 9 | 41 | |
| other | Vomiting | Gastrointestinal disorders | Momelotinib (MMB) | 7 | 41 | |
| other | Abdominal pain | Gastrointestinal disorders | Momelotinib (MMB) | 6 | 41 | |
| other | Constipation | Gastrointestinal disorders | Momelotinib (MMB) | 3 | 41 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Momelotinib (MMB) | 12 | 41 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Momelotinib (MMB) | 5 | 41 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Momelotinib (MMB) | 3 | 41 | |
| other | Dizziness | Nervous system disorders | Momelotinib (MMB) | 6 | 41 | |
| other | Headache | Nervous system disorders | Momelotinib (MMB) | 6 | 41 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Momelotinib (MMB) | 3 | 41 |
| Total, other adverse events | Momelotinib (MMB) | 36 | 41 |
| Total, serious adverse events | Momelotinib (MMB) | 14 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39516087 | DERIVED |
Source PubMed
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/NCT02515630
GET https://conductscience.org/api/trials/v1/NCT02515630/registered?page=2