NCT04682405 · OUTCOME

Time to Neutrophil Engraftment

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: Days
Interval / dispersion: Standard Deviation
Time frame: Through date of discharge (up to be 18 days)

What was measured

-Defined as ANC ≥0.5 x 10\^9/L for 3 consecutive days or ≥1.0 x 10\^9/L for 1 day

Analysis population: One subject dropped out of Placebo + Standard of Care Melphalan arm due to adverse events and was not included in the analysis for this 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

Group	Source count
Uproleselan + Standard of Care Melphalan	26
Placebo + Standard of Care Melphalan	24

Reported measurements

Source class 1

Values in Days · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Uproleselan + Standard of Care Melphalan	12.77	0.76	Not reported	Not reported	Not reported
Placebo + Standard of Care Melphalan	12.50	0.98	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.76
value
12.77
group Id
OG001
spread
0.98
value
12.50

denoms

counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants

description

-Defined as ANC ≥0.5 x 10\^9/L for 3 consecutive days or ≥1.0 x 10\^9/L for 1 day

dispersion Type

Standard Deviation

groups

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
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

One subject dropped out of Placebo + Standard of Care Melphalan arm due to adverse events and was not included in the analysis for this outcome measure.

reporting Status

POSTED

time Frame

Through date of discharge (up to be 18 days)

title

Time to Neutrophil Engraftment

type

SECONDARY

unit Of Measure

Days

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

Preserved source evidence · Not medical advice