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NCT04682405 · OUTCOME

Change in Bristol Stool Scale

Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM) · Source last updated 2023-12-15

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

What was measured

Change in Bristol Stool Scale as measured by incidence of Type 7 Bristol Stool Scale: liquid consistency with no solid pieces.

Analysis population: The number of participants analyzed at each time point may differ from the overall number of participants analyzed because the data was not collected. One patient in the placebo + standard of care melphalan arm was not evaluable for the outcome measure.

Groups in this outcome

Uproleselan + Standard of Care Melphalan

Patients will receive six doses of Uproleselan intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.

Placebo + Standard of Care Melphalan

Patients will receive six doses of placebo intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.

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

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24

Reported measurements

Day -3, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan23
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan0Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan1Not reportedNot reportedNot reportedNot reported
Day -3, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan0Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan1Not reportedNot reportedNot reportedNot reported
Day -2, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan0Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan2Not reportedNot reportedNot reportedNot reported
Day -2, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan0Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan1Not reportedNot reportedNot reportedNot reported
Day -1, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan0Not reportedNot reportedNot reportedNot reported
Day -1, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan0Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan1Not reportedNot reportedNot reportedNot reported
Day 0, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan3Not reportedNot reportedNot reportedNot reported
Day 0, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan0Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan1Not reportedNot reportedNot reportedNot reported
Day 1, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan5Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan4Not reportedNot reportedNot reportedNot reported
Day 1, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan3Not reportedNot reportedNot reportedNot reported
Day 2, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan3Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan5Not reportedNot reportedNot reportedNot reported
Day 2, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan6Not reportedNot reportedNot reportedNot reported
Day 3, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan11Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan8Not reportedNot reportedNot reportedNot reported
Day 3, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan5Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan10Not reportedNot reportedNot reportedNot reported
Day 4, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan8Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan12Not reportedNot reportedNot reportedNot reported
Day 4, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan4Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan11Not reportedNot reportedNot reportedNot reported
Day 5, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan7Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan12Not reportedNot reportedNot reportedNot reported
Day 5, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan6Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan10Not reportedNot reportedNot reportedNot reported
Day 6, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan12Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan11Not reportedNot reportedNot reportedNot reported
Day 6, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan12Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan11Not reportedNot reportedNot reportedNot reported
Day 7, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan14Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan10Not reportedNot reportedNot reportedNot reported
Day 7, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan15Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan12Not reportedNot reportedNot reportedNot reported
Day 8, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan14Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan15Not reportedNot reportedNot reportedNot reported
Day 8, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan19Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan14Not reportedNot reportedNot reportedNot reported
Day 9, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan18Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan16Not reportedNot reportedNot reportedNot reported
Day 9, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan13Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan17Not reportedNot reportedNot reportedNot reported
Day 10, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan13Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan16Not reportedNot reportedNot reportedNot reported
Day 10, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan10Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan19Not reportedNot reportedNot reportedNot reported
Day 11, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan9Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan19Not reportedNot reportedNot reportedNot reported
Day 11, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan8Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan11Not reportedNot reportedNot reportedNot reported
Day 12, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan11Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan9Not reportedNot reportedNot reportedNot reported
Day 12, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan8Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan7Not reportedNot reportedNot reportedNot reported
Day 13, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan26
Placebo + Standard of Care Melphalan23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan6Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan7Not reportedNot reportedNot reportedNot reported
Day 13, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan22
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan3Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan8Not reportedNot reportedNot reportedNot reported
Day 14, AM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan24
Placebo + Standard of Care Melphalan22
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan3Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan7Not reportedNot reportedNot reportedNot reported
Day 14, PM

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan20
Placebo + Standard of Care Melphalan16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2Not reportedNot reportedNot reportedNot reported
Placebo + Standard of Care Melphalan4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day -3, AM
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day -3, PM
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day -2, AM
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day -2, PM
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day -1, AM
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day -1, PM
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day 0, AM
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day 0, PM
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day 1, AM
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day 1, PM
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day 2, AM
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day 2, PM
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      24
    units
    Participants
description
Change in Bristol Stool Scale as measured by incidence of Type 7 Bristol Stool Scale: liquid consistency with no solid pieces.
groups
  1. description
    Patients will receive six doses of Uproleselan intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.
    id
    OG000
    title
    Uproleselan + Standard of Care Melphalan
  2. description
    Patients will receive six doses of placebo intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.
    id
    OG001
    title
    Placebo + Standard of Care Melphalan
param Type
COUNT_OF_PARTICIPANTS
population Description
The number of participants analyzed at each time point may differ from the overall number of participants analyzed because the data was not collected. One patient in the placebo + standard of care melphalan arm was not evaluable for the outcome measure.
reporting Status
POSTED
time Frame
From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
title
Change in Bristol Stool Scale
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice