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NCT04682405 · OUTCOME

Change in Nutritional Status as Assessed by Change in Standing Weight

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
MEAN
Unit
kilograms
Interval / dispersion
Standard Deviation
Time frame
Day -3, Day 8, and date of discharge or Day 14 (whichever is sooner) (up to be 18 days)

What was measured

Patient standing weight in kilograms was taken at specific time points to assess any changes in nutritional status.

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 Melphalan25
Placebo + Standard of Care Melphalan24

Reported measurements

Day -3

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in kilograms · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan93.2623.22Not reportedNot reportedNot reported
Placebo + Standard of Care Melphalan89.4822.37Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan24
Placebo + Standard of Care Melphalan23
Values in kilograms · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan92.8122.43Not reportedNot reportedNot reported
Placebo + Standard of Care Melphalan87.2420.67Not reportedNot reportedNot reported
Day 14 or day of discharge, whichever is sooner

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in kilograms · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan93.3424.11Not reportedNot reportedNot reported
Placebo + Standard of Care Melphalan89.4420.58Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.22
        value
        93.26
      2. group Id
        OG001
        spread
        22.37
        value
        89.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day -3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.43
        value
        92.81
      2. group Id
        OG001
        spread
        20.67
        value
        87.24
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.11
        value
        93.34
      2. group Id
        OG001
        spread
        20.58
        value
        89.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Day 14 or day of discharge, whichever is sooner
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      24
    units
    Participants
description
Patient standing weight in kilograms was taken at specific time points to assess any changes in nutritional status.
dispersion Type
Standard Deviation
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
MEAN
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
Day -3, Day 8, and date of discharge or Day 14 (whichever is sooner) (up to be 18 days)
title
Change in Nutritional Status as Assessed by Change in Standing Weight
type
SECONDARY
unit Of Measure
kilograms

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Preserved source evidence · Not medical advice