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NCT04173494 · OUTCOME

Leukemia-free Survival (LFS)

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) · Source last updated 2023-11-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Days
Interval / dispersion
Inter-Quartile Range
Time frame
Up to a maximum of 151 weeks

What was measured

LFS is defined as the interval from first study drug dosing date (or randomization date for participants who did not receive treatment) to any evidence of leukemic transformation and/or death (from any cause).

Analysis population: ITT Analysis Set. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.

Groups in this outcome

MMB 200 mg QD + Placebo

Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.

DAN 300 mg BID + Placebo

Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
MMB 200 mg QD + Placebo130
DAN 300 mg BID + Placebo65

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
MMB 200 mg QD + Placebo624.0Not reported325.0NA\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived
DAN 300 mg BID + PlaceboNANot reported284.0NA\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.466
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.386
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.4320
    param Type
    Hazard Ratio (HR)
    param Value
    0.804
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.466
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.386
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.4320
    param Type
    Hazard Ratio (HR)
    param Value
    0.804
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived
        group Id
        OG000
        lower Limit
        325.0
        upper Limit
        NA
        value
        624.0
      2. comment
        \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
        group Id
        OG001
        lower Limit
        284.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      130
    2. group Id
      OG001
      value
      65
    units
    Participants
description
LFS is defined as the interval from first study drug dosing date (or randomization date for participants who did not receive treatment) to any evidence of leukemic transformation and/or death (from any cause).
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.
    id
    OG000
    title
    MMB 200 mg QD + Placebo
  2. description
    Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.
    id
    OG001
    title
    DAN 300 mg BID + Placebo
param Type
MEDIAN
population Description
ITT Analysis Set. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.
reporting Status
POSTED
time Frame
Up to a maximum of 151 weeks
title
Leukemia-free Survival (LFS)
type
SECONDARY
unit Of Measure
Days

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice