Last updated: 07/23/2026 14:20:14

An Indirect Treatment Comparison of Momelotinib vs. Luspatercept plus JAKi for Myelofibrosis with transfusion dependent Anemia

GSK study ID
309966
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not applicable
Not applicable
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Comparative Efficacy and Safety of Momelotinib vs. Luspatercept plus JAKi in Myelofibrosis with Transfusion-Dependent Anemia: A Matching-Adjusted Indirect Comparison
Trial description: This observational study compares transfusion-related efficacy and safety outcomes of momelotinib from the SIMPLIFY-2 and MOMENTUM studies with those of luspatercept plus JAK inhibitor (JAKi) therapy from the INDEPENDENCE study in transfusion-dependent myelofibrosis patients, using a matching-adjusted indirect comparison (MAIC) to adjust for differences in baseline characteristics across the trials.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of participants with RBC transfusion independence (RBC-TI) for ≥12 weeks by end of week 24 (RBC-TI 12)

Timeframe: Up to week 24

Secondary outcomes:

Proportion of participants with RBC transfusion independence (RBC-TI) for ≥16 weeks by end of Week 24 (RBC-TI 16)

Timeframe: Up to week 24

Proportion of participants with ≥50 percentage (%) reduction in RBC transfusion burden from baseline and a reduction of ≥4 Units from Baseline for ≥12 weeks Through Week 24

Timeframe: Up to Week 24

Proportion of participants with ≥ 50% reduction in RBC transfusion burden from baseline for ≥12 weeks through week 24

Timeframe: Up to week 24

Proportion of participants with RBC-TI 12 and mean haemoglobin increase ≥ 1g/dL for ≥ 12 weeks through week 24

Timeframe: Up to week 24

Proportion of participants with any Treatment-emergent adverse event (TEAE), Treatment related TEAE, Grade 3/4 TEAE, Serious TEAE

Timeframe: Up to Extended Treatment Period (Up to approximately Week 204)

Proportion of participants with common TEAES (Thrombocytopenia, Hypertension, Peripheral oedema, Diarrhoea)

Timeframe: Up to Extended Treatment Period (Up to approximately Week 204)

Proportion of Death

Timeframe: Up to Extended Treatment Period (Up to approximately Week 204)

Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Myelofibrosis (MF)
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2026 to Invalid Date
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • To be eligible for inclusion in the momelotinib analysis population, patients from SIMPLIFY-2 and MOMENTUM must have received momelotinib during randomized treatment period
  • Received 4 to 12 RBC transfusion units during the 12 weeks prior to randomization.
  • Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:

    To be eligible for inclusion in the momelotinib analysis population, patients from SIMPLIFY-2 and MOMENTUM must have received momelotinib during randomized treatment period

    • Received 4 to 12 RBC transfusion units during the 12 weeks prior to randomization.
    • Had no interval greater than 42 days without at least 1 RBC transfusion during the 12-week baseline assessment period.
    • Had a baseline hemoglobin level of less than 10 g/dL.
Exclusion criteria:
  • Not Applicable

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Not applicable
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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