NCT04682405 · OUTCOME
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0
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
- MEDIAN
- Unit
- score on a scale
- Interval / dispersion
- Full Range
- Time frame
- Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
What was measured
* Questions regarding gastrointestinal, pain, and psychological symptoms interfering with daily activities
* Responses are scored from 1-5 with 1=not at all to 5=very much
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
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 25 |
|---|
| Placebo + Standard of Care Melphalan | 24 |
|---|
Reported measurements
Mouth or throat sore interference - Day -3
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 25 |
|---|
| Placebo + Standard of Care Melphalan | 24 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 1.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 3.00 | Not reported |
|---|
Mouth or throat sore interference - Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 25 |
|---|
| Placebo + Standard of Care Melphalan | 22 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 4.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 5.00 | Not reported |
|---|
Mouth or throat sore interference - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 23 |
|---|
| Placebo + Standard of Care Melphalan | 22 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 1.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 5.00 | Not reported |
|---|
Decreased appetite interference - Day -3
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 25 |
|---|
| Placebo + Standard of Care Melphalan | 24 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 3.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 3.00 | Not reported |
|---|
Decreased appetite interference - Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 25 |
|---|
| Placebo + Standard of Care Melphalan | 22 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 3.00 | Not reported | 1.00 | 5.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 3.50 | Not reported | 1.00 | 5.00 | Not reported |
|---|
Decreased appetite interference - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 23 |
|---|
| Placebo + Standard of Care Melphalan | 22 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 2.00 | Not reported | 1.00 | 5.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 3.00 | Not reported | 1.00 | 5.00 | Not reported |
|---|
Abdominal pain interference - Day -3
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 25 |
|---|
| Placebo + Standard of Care Melphalan | 24 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 3.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 2.00 | Not reported |
|---|
Abdominal pain interference - Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 25 |
|---|
| Placebo + Standard of Care Melphalan | 22 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 2.00 | Not reported | 1.00 | 4.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.50 | Not reported | 1.00 | 4.00 | Not reported |
|---|
Abdominal pain interference - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 23 |
|---|
| Placebo + Standard of Care Melphalan | 22 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 4.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 4.00 | Not reported |
|---|
Bowel incontinence interference - Day -3
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 24 |
|---|
| Placebo + Standard of Care Melphalan | 24 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 3.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 2.00 | Not reported |
|---|
Bowel incontinence interference - Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 25 |
|---|
| Placebo + Standard of Care Melphalan | 22 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 5.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 4.00 | Not reported |
|---|
Bowel incontinence interference - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
| Group | Source count |
|---|
| Uproleselan + Standard of Care Melphalan | 23 |
|---|
| Placebo + Standard of Care Melphalan | 22 |
|---|
Values in score on a scale · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Uproleselan + Standard of Care Melphalan | 2.00 | Not reported | 1.00 | 5.00 | Not reported |
|---|
| Placebo + Standard of Care Melphalan | 1.00 | Not reported | 1.00 | 5.00 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 1.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Mouth or throat sore interference - Day -3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Mouth or throat sore interference - Day 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 1.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Mouth or throat sore interference - date of discharge or Day 14 (whichever is sooner)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Decreased appetite interference - Day -3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 3.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 3.50
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Decreased appetite interference - Day 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 2.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 3.00
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Decreased appetite interference - date of discharge or Day 14 (whichever is sooner)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 2.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Abdominal pain interference - Day -3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 2.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 1.50
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Abdominal pain interference - Day 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Abdominal pain interference - date of discharge or Day 14 (whichever is sooner)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 2.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Bowel incontinence interference - Day -3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Bowel incontinence interference - Day 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 2.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 5.00
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Bowel incontinence interference - date of discharge or Day 14 (whichever is sooner)
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 24
- units
- Participants
- description
- * Questions regarding gastrointestinal, pain, and psychological symptoms interfering with daily activities
* Responses are scored from 1-5 with 1=not at all to 5=very much
- dispersion Type
- Full Range
- 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
- MEDIAN
- 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, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
- title
- Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0
- type
- SECONDARY
- unit Of Measure
- score on a scale
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