Trial Outcomes & Findings for Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM) (NCT NCT04682405)

Last Updated: 2023-12-15

Results Overview

Grade 0 is defined as no diarrhea, or no change from baseline. Grade 1 is defined as an increase of \<4 stools per day over baseline; mild increase in ostomy output compared to baseline. Grade 2 is defined as an increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL. Grade 3 is defined as an increase of \>=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limited self care ADL. Grade 4 is defined as life-threatening consequences; urgent intervention indicated. Grade 5 is defined as death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Results posted on

2023-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	26	25
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	0	1

Baseline Characteristics

Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=25 Participants 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.	Total n=51 Participants Total of all reporting groups
Age, Continuous	65.5 years n=93 Participants	64 years n=4 Participants	64 years n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	11 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	14 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=93 Participants	25 Participants n=4 Participants	51 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	26 Participants n=93 Participants	23 Participants n=4 Participants	49 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	26 Participants n=93 Participants	25 Participants n=4 Participants	51 Participants n=27 Participants

PRIMARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

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.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Diarrhea as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.13 CTCAE grade Standard Deviation 0.34
Change in Diarrhea as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.13 CTCAE grade Standard Deviation 0.34
Change in Diarrhea as Assessed Per CTCAE v5.0 Day -1	0.31 CTCAE grade Standard Deviation 0.55	0.38 CTCAE grade Standard Deviation 0.58
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 0	0.19 CTCAE grade Standard Deviation 0.40	0.21 CTCAE grade Standard Deviation 0.41
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 1	0.23 CTCAE grade Standard Deviation 0.51	0.25 CTCAE grade Standard Deviation 0.53
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 2	0.42 CTCAE grade Standard Deviation 0.58	0.46 CTCAE grade Standard Deviation 0.66
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 3	0.65 CTCAE grade Standard Deviation 0.75	0.88 CTCAE grade Standard Deviation 0.85
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 4	0.88 CTCAE grade Standard Deviation 0.71	1.08 CTCAE grade Standard Deviation 1.02
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 5	1.00 CTCAE grade Standard Deviation 0.75	1.29 CTCAE grade Standard Deviation 0.55
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 6	1.19 CTCAE grade Standard Deviation 0.85	1.42 CTCAE grade Standard Deviation 0.97
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 7	1.42 CTCAE grade Standard Deviation 0.95	1.38 CTCAE grade Standard Deviation 0.77
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 8	1.38 CTCAE grade Standard Deviation 0.85	1.63 CTCAE grade Standard Deviation 0.92
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 9	1.54 CTCAE grade Standard Deviation 0.86	1.54 CTCAE grade Standard Deviation 0.93
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 10	1.54 CTCAE grade Standard Deviation 0.86	1.92 CTCAE grade Standard Deviation 0.97
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 11	1.46 CTCAE grade Standard Deviation 1.07	1.63 CTCAE grade Standard Deviation 0.92
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 12	1.23 CTCAE grade Standard Deviation 0.95	1.17 CTCAE grade Standard Deviation 0.92
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 13	1.00 CTCAE grade Standard Deviation 0.98	1.13 CTCAE grade Standard Deviation 0.76
Change in Diarrhea as Assessed Per CTCAE v5.0 Day 14	0.92 CTCAE grade Standard Deviation 0.76	0.95 CTCAE grade Standard Deviation 0.72

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 oral mucositis is defined as no presence of mucositis. Grade 1 oral mucositis is defined as asymptomatic or mild symptoms; intervention not indicated. Grade 2 oral mucositis is defined as moderate pain or ulcer that does not interfere with oral intake; modified diet indicated. Grade 3 oral mucositis is defined as severe pain; interfering with oral intake. Grade 4 oral mucositis is defined as life-threatening consequences; urgent intervention indicated. Grade 5 oral mucositis is defined as death.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day -1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 0	0.00 CTCAE grade Standard Deviation 0.00	0.08 CTCAE grade Standard Deviation 0.28
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 1	0.00 CTCAE grade Standard Deviation 0.00	0.08 CTCAE grade Standard Deviation 0.28
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 2	0.12 CTCAE grade Standard Deviation 0.33	0.08 CTCAE grade Standard Deviation 0.28
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 3	0.16 CTCAE grade Standard Deviation 0.33	0.04 CTCAE grade Standard Deviation 0.20
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 4	0.08 CTCAE grade Standard Deviation 0.27	0.08 CTCAE grade Standard Deviation 0.28
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 5	0.12 CTCAE grade Standard Deviation 0.33	0.04 CTCAE grade Standard Deviation 0.20
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 6	0.12 CTCAE grade Standard Deviation 0.43	0.17 CTCAE grade Standard Deviation 0.48
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 7	0.31 CTCAE grade Standard Deviation 0.62	0.42 CTCAE grade Standard Deviation 0.88
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 8	0.23 CTCAE grade Standard Deviation 0.51	0.33 CTCAE grade Standard Deviation 0.70
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 9	0.38 CTCAE grade Standard Deviation 0.64	0.38 CTCAE grade Standard Deviation 0.71
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 10	0.35 CTCAE grade Standard Deviation 0.56	0.33 CTCAE grade Standard Deviation 0.70
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 11	0.27 CTCAE grade Standard Deviation 0.53	0.38 CTCAE grade Standard Deviation 0.65
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 12	0.15 CTCAE grade Standard Deviation 0.46	0.21 CTCAE grade Standard Deviation 0.51
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 13	0.15 CTCAE grade Standard Deviation 0.54	0.22 CTCAE grade Standard Deviation 0.52
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Day 14	0.04 CTCAE grade Standard Deviation 0.20	0.23 CTCAE grade Standard Deviation 0.53

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 esophagitis is defined as no presence of esophagitis. Grade 1 esophagitis is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 esophagitis is defined as symptomatic; altered GI function; limiting instrumental ADL. Grade 3 esophagitis is defined as severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self care ADL. Grade 4 esophagitis is defined as life-threatening consequences; urgent operative intervention indicated. Grade 5 esophagitis is defined as death.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Esophagitis as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophagitis as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophagitis as Assessed Per CTCAE v5.0 Day -1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 0	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 2	0.08 CTCAE grade Standard Deviation 0.27	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 3	0.04 CTCAE grade Standard Deviation 0.20	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 4	0.04 CTCAE grade Standard Deviation 0.20	0.04 CTCAE grade Standard Deviation 0.20
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 5	0.04 CTCAE grade Standard Deviation 0.20	0.04 CTCAE grade Standard Deviation 0.20
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 6	0.12 CTCAE grade Standard Deviation 0.43	0.17 CTCAE grade Standard Deviation 0.48
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 7	0.23 CTCAE grade Standard Deviation 0.71	0.25 CTCAE grade Standard Deviation 0.68
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 8	0.58 CTCAE grade Standard Deviation 1.03	0.25 CTCAE grade Standard Deviation 0.61
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 9	0.54 CTCAE grade Standard Deviation 0.90	0.25 CTCAE grade Standard Deviation 0.61
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 10	0.46 CTCAE grade Standard Deviation 0.86	0.25 CTCAE grade Standard Deviation 0.61
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 11	0.38 CTCAE grade Standard Deviation 0.80	0.29 CTCAE grade Standard Deviation 0.62
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 12	0.19 CTCAE grade Standard Deviation 0.57	0.21 CTCAE grade Standard Deviation 0.51
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 13	0.12 CTCAE grade Standard Deviation 0.43	0.13 CTCAE grade Standard Deviation 0.34
Change in Esophagitis as Assessed Per CTCAE v5.0 Day 14	0.04 CTCAE grade Standard Deviation 0.20	0.14 CTCAE grade Standard Deviation 0.35

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 gastritis is defined as no presence of esophagitis. Grade 1 gastritis is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 gastritis is defined as symptomatic; altered GI function; medical intervention indicated. Grade 3 gastritis is defined as severely altered eating or gastric function; TPN or hospitalization indicated. Grade 4 gastritis is defined as life-threatening consequences; urgent operative intervention indicated. Grade 5 gastritis is defined as death.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Gastritis as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Gastritis as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Gastritis as Assessed Per CTCAE v5.0 Day -1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Gastritis as Assessed Per CTCAE v5.0 Day 0	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Gastritis as Assessed Per CTCAE v5.0 Day 1	0.04 CTCAE grade Standard Deviation 0.20	0.04 CTCAE grade Standard Deviation 0.20
Change in Gastritis as Assessed Per CTCAE v5.0 Day 2	0.15 CTCAE grade Standard Deviation 0.46	0.13 CTCAE grade Standard Deviation 0.45
Change in Gastritis as Assessed Per CTCAE v5.0 Day 3	0.00 CTCAE grade Standard Deviation 0.00	0.08 CTCAE grade Standard Deviation 0.41
Change in Gastritis as Assessed Per CTCAE v5.0 Day 4	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Gastritis as Assessed Per CTCAE v5.0 Day 5	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Gastritis as Assessed Per CTCAE v5.0 Day 6	0.08 CTCAE grade Standard Deviation 0.39	0.08 CTCAE grade Standard Deviation 0.28
Change in Gastritis as Assessed Per CTCAE v5.0 Day 7	0.12 CTCAE grade Standard Deviation 0.59	0.08 CTCAE grade Standard Deviation 0.41
Change in Gastritis as Assessed Per CTCAE v5.0 Day 8	0.19 CTCAE grade Standard Deviation 0.63	0.04 CTCAE grade Standard Deviation 0.21
Change in Gastritis as Assessed Per CTCAE v5.0 Day 9	0.23 CTCAE grade Standard Deviation 0.65	0.09 CTCAE grade Standard Deviation 0.29
Change in Gastritis as Assessed Per CTCAE v5.0 Day 10	0.19 CTCAE grade Standard Deviation 0.63	0.13 CTCAE grade Standard Deviation 0.45
Change in Gastritis as Assessed Per CTCAE v5.0 Day 11	0.12 CTCAE grade Standard Deviation 0.59	0.17 CTCAE grade Standard Deviation 0.48
Change in Gastritis as Assessed Per CTCAE v5.0 Day 12	0.08 CTCAE grade Standard Deviation 0.39	0.13 CTCAE grade Standard Deviation 0.34
Change in Gastritis as Assessed Per CTCAE v5.0 Day 13	0.04 CTCAE grade Standard Deviation 0.20	0.09 CTCAE grade Standard Deviation 0.29
Change in Gastritis as Assessed Per CTCAE v5.0 Day 14	0.00 CTCAE grade Standard Deviation 0.00	0.05 CTCAE grade Standard Deviation 0.21

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 esophageal pain is defined as no esophageal pain. Grade 1 esophageal pain is defined as mild pain. Grade 2 esophageal pain is defined as moderate pain; limiting instrumental ADL. Grade 3 esophageal pain is defined as severe pain; limiting self care ADL. There is no grade 4 or 5 esophageal pain defined in the CTCAE v5.0.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day -1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 0	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 1	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 2	0.12 CTCAE grade Standard Deviation 0.33	0.04 CTCAE grade Standard Deviation 0.20
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 3	0.04 CTCAE grade Standard Deviation 0.20	0.04 CTCAE grade Standard Deviation 0.20
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 4	0.08 CTCAE grade Standard Deviation 0.27	0.13 CTCAE grade Standard Deviation 0.34
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 5	0.04 CTCAE grade Standard Deviation 0.20	0.13 CTCAE grade Standard Deviation 0.34
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 6	0.19 CTCAE grade Standard Deviation 0.49	0.29 CTCAE grade Standard Deviation 0.75
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 7	0.35 CTCAE grade Standard Deviation 0.80	0.46 CTCAE grade Standard Deviation 0.88
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 8	0.46 CTCAE grade Standard Deviation 0.81	0.33 CTCAE grade Standard Deviation 0.76
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 9	0.46 CTCAE grade Standard Deviation 0.71	0.29 CTCAE grade Standard Deviation 0.69
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 10	0.38 CTCAE grade Standard Deviation 0.64	0.33 CTCAE grade Standard Deviation 0.76
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 11	0.31 CTCAE grade Standard Deviation 0.55	0.25 CTCAE grade Standard Deviation 0.61
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 12	0.19 CTCAE grade Standard Deviation 0.49	0.17 CTCAE grade Standard Deviation 0.56
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 13	0.23 CTCAE grade Standard Deviation 0.59	0.13 CTCAE grade Standard Deviation 0.46
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Day 14	0.00 CTCAE grade Standard Deviation 0.00	0.14 CTCAE grade Standard Deviation 0.47

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 abdominal pain is defined as no abdominal pain. Grade 1 abdominal pain is defined as mild pain. Grade 2 abdominal pain is defined as moderate pain; limiting instrumental ADL. Grade 3 abdominal pain is defined as severe pain; limiting self care ADL. There is no grade 4 or 5 abdominal pain defined in the CTCAE v5.0.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day -1	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 0	0.16 CTCAE grade Standard Deviation 0.37	0.04 CTCAE grade Standard Deviation 0.20
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 1	0.19 CTCAE grade Standard Deviation 0.40	0.17 CTCAE grade Standard Deviation 0.38
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 2	0.35 CTCAE grade Standard Deviation 0.56	0.25 CTCAE grade Standard Deviation 0.44
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 3	0.12 CTCAE grade Standard Deviation 0.33	0.13 CTCAE grade Standard Deviation 0.34
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 4	0.12 CTCAE grade Standard Deviation 0.33	0.25 CTCAE grade Standard Deviation 0.61
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 5	0.08 CTCAE grade Standard Deviation 0.27	0.13 CTCAE grade Standard Deviation 0.34
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 6	0.31 CTCAE grade Standard Deviation 0.68	0.21 CTCAE grade Standard Deviation 0.41
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 7	0.35 CTCAE grade Standard Deviation 0.63	0.29 CTCAE grade Standard Deviation 0.46
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 8	0.58 CTCAE grade Standard Deviation 0.70	0.54 CTCAE grade Standard Deviation 0.88
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 9	0.54 CTCAE grade Standard Deviation 0.81	0.50 CTCAE grade Standard Deviation 0.98
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 10	0.38 CTCAE grade Standard Deviation 0.64	0.46 CTCAE grade Standard Deviation 0.78
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 11	0.15 CTCAE grade Standard Deviation 0.37	0.38 CTCAE grade Standard Deviation 0.65
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 12	0.23 CTCAE grade Standard Deviation 0.43	0.29 CTCAE grade Standard Deviation 0.62
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 13	0.12 CTCAE grade Standard Deviation 0.33	0.22 CTCAE grade Standard Deviation 0.42
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Day 14	0.12 CTCAE grade Standard Deviation 0.33	0.05 CTCAE grade Standard Deviation 0.21

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 nausea is defined as no nausea. Grade 1 nausea is defined as loss of appetite without alteration in eating habits. Grade 2 nausea is defined as oral intake decreased without significant weight loss, dehydration or malnutrition. Grade 3 nausea is defined as inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated. There is no grade 4 or 5 nausea defined in the CTCAE v5.0.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Nausea as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.08 CTCAE grade Standard Deviation 0.28
Change in Nausea as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.08 CTCAE grade Standard Deviation 0.28
Change in Nausea as Assessed Per CTCAE v5.0 Day -1	0.12 CTCAE grade Standard Deviation 0.33	0.21 CTCAE grade Standard Deviation 0.51
Change in Nausea as Assessed Per CTCAE v5.0 Day 0	0.35 CTCAE grade Standard Deviation 0.63	0.42 CTCAE grade Standard Deviation 0.72
Change in Nausea as Assessed Per CTCAE v5.0 Day 1	0.62 CTCAE grade Standard Deviation 0.75	0.63 CTCAE grade Standard Deviation 0.82
Change in Nausea as Assessed Per CTCAE v5.0 Day 2	1.04 CTCAE grade Standard Deviation 0.82	1.13 CTCAE grade Standard Deviation 0.95
Change in Nausea as Assessed Per CTCAE v5.0 Day 3	1.00 CTCAE grade Standard Deviation 0.80	0.92 CTCAE grade Standard Deviation 0.88
Change in Nausea as Assessed Per CTCAE v5.0 Day 4	1.00 CTCAE grade Standard Deviation 0.80	1.17 CTCAE grade Standard Deviation 0.82
Change in Nausea as Assessed Per CTCAE v5.0 Day 5	0.92 CTCAE grade Standard Deviation 0.63	1.29 CTCAE grade Standard Deviation 0.86
Change in Nausea as Assessed Per CTCAE v5.0 Day 6	1.23 CTCAE grade Standard Deviation 0.82	1.33 CTCAE grade Standard Deviation 0.76
Change in Nausea as Assessed Per CTCAE v5.0 Day 7	1.35 CTCAE grade Standard Deviation 0.80	1.42 CTCAE grade Standard Deviation 0.88
Change in Nausea as Assessed Per CTCAE v5.0 Day 8	1.23 CTCAE grade Standard Deviation 0.91	1.21 CTCAE grade Standard Deviation 0.93
Change in Nausea as Assessed Per CTCAE v5.0 Day 9	1.19 CTCAE grade Standard Deviation 0.85	1.38 CTCAE grade Standard Deviation 1.01
Change in Nausea as Assessed Per CTCAE v5.0 Day 10	1.08 CTCAE grade Standard Deviation 0.84	1.42 CTCAE grade Standard Deviation 1.02
Change in Nausea as Assessed Per CTCAE v5.0 Day 11	0.65 CTCAE grade Standard Deviation 0.80	1.29 CTCAE grade Standard Deviation 0.95
Change in Nausea as Assessed Per CTCAE v5.0 Day 12	0.62 CTCAE grade Standard Deviation 0.80	1.00 CTCAE grade Standard Deviation 0.98
Change in Nausea as Assessed Per CTCAE v5.0 Day 13	0.65 CTCAE grade Standard Deviation 0.85	0.83 CTCAE grade Standard Deviation 0.98
Change in Nausea as Assessed Per CTCAE v5.0 Day 14	0.20 CTCAE grade Standard Deviation 0.41	0.59 CTCAE grade Standard Deviation 0.96

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 vomiting is defined as no vomiting. Grade 1 vomiting is defined as intervention not indicated. Grade 2 vomiting is defined as outpatient IV hydration; medical intervention indicated. Grade 3 vomiting is defined as tube feeding, TPN, or hospitalization indicated. Grade 4 vomiting is defined as life-threatening consequences. Grade 5 vomiting is defined as death.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Vomiting as Assessed Per CTCAE v5.0 Day 8	0.62 CTCAE grade Standard Deviation 0.94	0.42 CTCAE grade Standard Deviation 0.78
Change in Vomiting as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Vomiting as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Vomiting as Assessed Per CTCAE v5.0 Day -1	0.04 CTCAE grade Standard Deviation 0.20	0.08 CTCAE grade Standard Deviation 0.41
Change in Vomiting as Assessed Per CTCAE v5.0 Day 0	0.12 CTCAE grade Standard Deviation 0.43	0.29 CTCAE grade Standard Deviation 0.62
Change in Vomiting as Assessed Per CTCAE v5.0 Day 1	0.27 CTCAE grade Standard Deviation 0.60	0.29 CTCAE grade Standard Deviation 0.62
Change in Vomiting as Assessed Per CTCAE v5.0 Day 2	0.35 CTCAE grade Standard Deviation 0.69	0.63 CTCAE grade Standard Deviation 0.82
Change in Vomiting as Assessed Per CTCAE v5.0 Day 3	0.15 CTCAE grade Standard Deviation 0.46	0.50 CTCAE grade Standard Deviation 0.83
Change in Vomiting as Assessed Per CTCAE v5.0 Day 4	0.15 CTCAE grade Standard Deviation 0.46	0.67 CTCAE grade Standard Deviation 0.92
Change in Vomiting as Assessed Per CTCAE v5.0 Day 5	0.19 CTCAE grade Standard Deviation 0.57	0.54 CTCAE grade Standard Deviation 0.78
Change in Vomiting as Assessed Per CTCAE v5.0 Day 6	0.19 CTCAE grade Standard Deviation 0.49	0.46 CTCAE grade Standard Deviation 0.83
Change in Vomiting as Assessed Per CTCAE v5.0 Day 7	0.46 CTCAE grade Standard Deviation 0.86	0.67 CTCAE grade Standard Deviation 0.92
Change in Vomiting as Assessed Per CTCAE v5.0 Day 9	0.42 CTCAE grade Standard Deviation 0.70	0.42 CTCAE grade Standard Deviation 0.78
Change in Vomiting as Assessed Per CTCAE v5.0 Day 10	0.19 CTCAE grade Standard Deviation 0.49	0.38 CTCAE grade Standard Deviation 0.77
Change in Vomiting as Assessed Per CTCAE v5.0 Day 11	0.15 CTCAE grade Standard Deviation 0.54	0.38 CTCAE grade Standard Deviation 0.77
Change in Vomiting as Assessed Per CTCAE v5.0 Day 12	0.08 CTCAE grade Standard Deviation 0.28	0.29 CTCAE grade Standard Deviation 0.62
Change in Vomiting as Assessed Per CTCAE v5.0 Day 13	0.00 CTCAE grade Standard Deviation 0.00	0.13 CTCAE grade Standard Deviation 0.46
Change in Vomiting as Assessed Per CTCAE v5.0 Day 14	0.12 CTCAE grade Standard Deviation 0.44	0.09 CTCAE grade Standard Deviation 0.43

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 enterocolitis is defined as no enterocolitis. Grade 1 enterocolitis is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 enterocolitis is defined as abdominal pain; mucus or blood in stool. Grade 3 enterocolitis is defined as severe or persistent abdominal pain; fever; ileus; peritoneal signs. Grade 4 enterocolitis is defined as life-threatening consequences; urgent intervention indicated. Grade 5 enterocolitis is defined as death.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day -1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 0	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 1	0.08 CTCAE grade Standard Deviation 0.27	0.04 CTCAE grade Standard Deviation 0.20
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 2	0.04 CTCAE grade Standard Deviation 0.20	0.08 CTCAE grade Standard Deviation 0.41
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 4	0.04 CTCAE grade Standard Deviation 0.20	0.04 CTCAE grade Standard Deviation 0.20
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 5	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 6	0.00 CTCAE grade Standard Deviation 0.00	0.08 CTCAE grade Standard Deviation 0.28
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 7	0.12 CTCAE grade Standard Deviation 0.33	0.08 CTCAE grade Standard Deviation 0.28
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 8	0.27 CTCAE grade Standard Deviation 0.67	0.25 CTCAE grade Standard Deviation 0.61
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 9	0.27 CTCAE grade Standard Deviation 0.60	0.38 CTCAE grade Standard Deviation 0.61
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 10	0.23 CTCAE grade Standard Deviation 0.59	0.38 CTCAE grade Standard Deviation 0.82
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 11	0.12 CTCAE grade Standard Deviation 0.43	0.25 CTCAE grade Standard Deviation 0.61
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 12	0.08 CTCAE grade Standard Deviation 0.39	0.25 CTCAE grade Standard Deviation 0.61
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 13	0.04 CTCAE grade Standard Deviation 0.20	0.13 CTCAE grade Standard Deviation 0.34
Change in Enterocolitis as Assessed Per CTCAE v5.0 Day 14	0.00 CTCAE grade Standard Deviation 0.00	0.05 CTCAE grade Standard Deviation 0.21

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 proctitis is defined as no proctitis. Grade 1 proctitis is defined as rectal discomfort, intervention not indicated. Grade 2 proctitis is defined as symptomatic (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL. Grade 3 proctitis is defined as severe symptoms; fecal urgency or stool incontinence; limiting self-care ADL. Grade 4 proctitis is defined as life-threatening consequences; urgent intervention indicated. Grade 5 proctitis is defined as death.

Outcome measures

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 hemorrhoids is defined as no hemorrhoids. Grade 1 hemorrhoids is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 hemorrhoids is defined as symptomatic; banding or medical intervention indicated. Grade 3 hemorrhoids is defined as severe symptoms; invasive intervention indicated. There is no grade 4 or 5 hemorrhoids defined in the CTCAE v5.0.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day -1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 0	0.04 CTCAE grade Standard Deviation 0.20	0.00 CTCAE grade Standard Deviation 0.00
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 1	0.04 CTCAE grade Standard Deviation 0.20	0.00 CTCAE grade Standard Deviation 0.00
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 2	0.08 CTCAE grade Standard Deviation 0.27	0.00 CTCAE grade Standard Deviation 0.00
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 3	0.08 CTCAE grade Standard Deviation 0.39	0.00 CTCAE grade Standard Deviation 0.00
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 4	0.12 CTCAE grade Standard Deviation 0.43	0.04 CTCAE grade Standard Deviation 0.20
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 5	0.12 CTCAE grade Standard Deviation 0.43	0.08 CTCAE grade Standard Deviation 0.28
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 6	0.15 CTCAE grade Standard Deviation 0.46	0.08 CTCAE grade Standard Deviation 0.28
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 7	0.08 CTCAE grade Standard Deviation 0.27	0.08 CTCAE grade Standard Deviation 0.28
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 8	0.08 CTCAE grade Standard Deviation 0.27	0.04 CTCAE grade Standard Deviation 0.20
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 9	0.15 CTCAE grade Standard Deviation 0.37	0.08 CTCAE grade Standard Deviation 0.28
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 10	0.12 CTCAE grade Standard Deviation 0.33	0.08 CTCAE grade Standard Deviation 0.28
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 11	0.15 CTCAE grade Standard Deviation 0.37	0.04 CTCAE grade Standard Deviation 0.20
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 12	0.16 CTCAE grade Standard Deviation 0.37	0.08 CTCAE grade Standard Deviation 0.28
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 13	0.04 CTCAE grade Standard Deviation 0.20	0.09 CTCAE grade Standard Deviation 0.29
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Day 14	0.08 CTCAE grade Standard Deviation 0.28	0.09 CTCAE grade Standard Deviation 0.29

SECONDARY outcome

Timeframe: Through date of discharge (up to be 18 days)

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.

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

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Time to Neutrophil Engraftment	12.77 Days Standard Deviation 0.76	12.50 Days Standard Deviation 0.98

SECONDARY outcome

Timeframe: Before conditioning and at day +14 or date of discharge (whichever is sooner) (up to be 18 days)

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.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Nutritional Status as Assessed by Total Parenteral Nutrition (TPN) Days	0.19 Days Standard Deviation 0.98	0.00 Days Standard Deviation 0.00

SECONDARY outcome

Timeframe: From date of admission for auto-HCT to date of discharge (up to be 18 days)

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.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Duration of Hospital Length of Stay	18.42 Days Standard Deviation 1.98	18.46 Days Standard Deviation 1.84

SECONDARY outcome

Timeframe: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

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

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Bristol Stool Scale Day -3, AM	0 Participants	1 Participants
Change in Bristol Stool Scale Day -3, PM	0 Participants	1 Participants
Change in Bristol Stool Scale Day -2, AM	0 Participants	2 Participants
Change in Bristol Stool Scale Day -2, PM	0 Participants	1 Participants
Change in Bristol Stool Scale Day -1, AM	1 Participants	0 Participants
Change in Bristol Stool Scale Day -1, PM	0 Participants	1 Participants
Change in Bristol Stool Scale Day 0, AM	1 Participants	3 Participants
Change in Bristol Stool Scale Day 0, PM	0 Participants	1 Participants
Change in Bristol Stool Scale Day 1, AM	5 Participants	4 Participants
Change in Bristol Stool Scale Day 1, PM	1 Participants	3 Participants
Change in Bristol Stool Scale Day 2, AM	3 Participants	5 Participants
Change in Bristol Stool Scale Day 2, PM	2 Participants	6 Participants
Change in Bristol Stool Scale Day 3, AM	11 Participants	8 Participants
Change in Bristol Stool Scale Day 3, PM	5 Participants	10 Participants
Change in Bristol Stool Scale Day 4, AM	8 Participants	12 Participants
Change in Bristol Stool Scale Day 4, PM	4 Participants	11 Participants
Change in Bristol Stool Scale Day 5, AM	7 Participants	12 Participants
Change in Bristol Stool Scale Day 5, PM	6 Participants	10 Participants
Change in Bristol Stool Scale Day 6, AM	12 Participants	11 Participants
Change in Bristol Stool Scale Day 6, PM	12 Participants	11 Participants
Change in Bristol Stool Scale Day 7, AM	14 Participants	10 Participants
Change in Bristol Stool Scale Day 7, PM	15 Participants	12 Participants
Change in Bristol Stool Scale Day 8, AM	14 Participants	15 Participants
Change in Bristol Stool Scale Day 8, PM	19 Participants	14 Participants
Change in Bristol Stool Scale Day 9, AM	18 Participants	16 Participants
Change in Bristol Stool Scale Day 9, PM	13 Participants	17 Participants
Change in Bristol Stool Scale Day 10, AM	13 Participants	16 Participants
Change in Bristol Stool Scale Day 10, PM	10 Participants	19 Participants
Change in Bristol Stool Scale Day 11, AM	9 Participants	19 Participants
Change in Bristol Stool Scale Day 11, PM	8 Participants	11 Participants
Change in Bristol Stool Scale Day 12, AM	11 Participants	9 Participants
Change in Bristol Stool Scale Day 12, PM	8 Participants	7 Participants
Change in Bristol Stool Scale Day 13, AM	6 Participants	7 Participants
Change in Bristol Stool Scale Day 13, PM	3 Participants	8 Participants
Change in Bristol Stool Scale Day 14, AM	3 Participants	7 Participants
Change in Bristol Stool Scale Day 14, PM	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Day -3, Day 8, and date of discharge or Day 14 (whichever is sooner) (up to be 18 days)

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

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=25 Participants 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 n=24 Participants 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.
Change in Nutritional Status as Assessed by Change in Standing Weight Day -3	93.26 kilograms Standard Deviation 23.22	89.48 kilograms Standard Deviation 22.37
Change in Nutritional Status as Assessed by Change in Standing Weight Day 8	92.81 kilograms Standard Deviation 22.43	87.24 kilograms Standard Deviation 20.67
Change in Nutritional Status as Assessed by Change in Standing Weight Day 14 or day of discharge, whichever is sooner	93.34 kilograms Standard Deviation 24.11	89.44 kilograms Standard Deviation 20.58

SECONDARY outcome

Timeframe: Through date of discharge (upto be 18 days)

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Incidence of Infection Assessed by Rates of Bacteremia (With Organism Reported When Available)	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Through date of discharge (up to be day 18)

Measured by the time in days to the first antibiotic dose for bacteremia.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=23 Participants 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 n=23 Participants 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.
Time to First Antibiotics	10.00 days Interval 0.0 to 13.0	9.00 days Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: Through date of discharge (up to be 18 days)

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Incidence of Clostridium Difficile Infections	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Through date of discharge (up to be 18 days)

This is defined as the number of doses of anti-diarrheal medications, such as loperamide or lomotil, that participants took daily.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=23 Participants 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 n=21 Participants 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.
Median Daily Dose of Anti-diarrheal Medications	2.20 number of doses in one day Interval 1.0 to 4.33	2.00 number of doses in one day Interval 1.0 to 5.5

SECONDARY outcome

Timeframe: Through date of discharge (up to be 18 days)

The median daily dose of pain medications is provided as morphine equivalents.

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=18 Participants 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 n=18 Participants 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.
Median Daily Dose of Pain Medications	13.02 mg morphine equivalents Interval 2.5 to 38.75	15.65 mg morphine equivalents Interval 5.0 to 43.39

SECONDARY outcome

Timeframe: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)

* Questions regarding gastrointestinal toxicities * Responses are scored from 1-5 with 1=no symptoms to 5=severe symptoms

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=25 Participants 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 n=24 Participants 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.
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of nausea - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 4.0	2.50 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of vomiting - Day -3	1.00 score on a scale Interval 1.0 to 1.0	1.00 score on a scale Interval 1.0 to 2.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of vomiting - Day 8	2.00 score on a scale Interval 1.0 to 4.0	2.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of vomiting - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 4.0	2.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of heartburn - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of heartburn - Day 8	1.00 score on a scale Interval 1.0 to 4.0	1.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of heartburn - date of discharge or Day 14 (whichever is sooner)	1.00 score on a scale Interval 1.0 to 3.0	1.50 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of bloating - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of bloating - Day 8	2.00 score on a scale Interval 1.0 to 5.0	2.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of bloating - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 3.0	1.50 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of abdominal pain - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 2.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of abdominal pain - Day 8	2.00 score on a scale Interval 1.0 to 4.0	2.50 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of abdominal pain - date of discharge or Day 14 (whichever is sooner)	1.00 score on a scale Interval 1.0 to 3.0	2.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of difficulty swallowing - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 2.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of difficulty swallowing - Day 8	1.00 score on a scale Interval 1.0 to 5.0	1.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of difficulty swallowing - date of discharge or Day 14 (whichever is sooner)	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of mouth or throat sores - Day -3	1.00 score on a scale Interval 1.0 to 1.0	1.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of mouth or throat sores - Day 8	1.00 score on a scale Interval 1.0 to 4.0	1.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of mouth or throat sores - date of discharge or Day 14 (whichever is sooner)	1.00 score on a scale Interval 1.0 to 2.0	1.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of decreased appetite - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of decreased appetite - Day 8	3.00 score on a scale Interval 2.0 to 5.0	4.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of decreased appetite - date of discharge or Day 14 (whichever is sooner)	3.00 score on a scale Interval 1.0 to 4.0	3.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of nausea - Day -3	1.00 score on a scale Interval 1.0 to 2.0	1.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Severity of nausea - Day 8	3.00 score on a scale Interval 1.0 to 5.0	3.50 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)

* 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

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=25 Participants 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 n=24 Participants 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.
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Abdominal pain interference - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 2.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Abdominal pain interference - Day 8	2.00 score on a scale Interval 1.0 to 4.0	1.50 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Abdominal pain interference - date of discharge or Day 14 (whichever is sooner)	1.00 score on a scale Interval 1.0 to 4.0	1.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Bowel incontinence interference - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 2.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Bowel incontinence interference - Day 8	1.00 score on a scale Interval 1.0 to 5.0	1.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Bowel incontinence interference - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 5.0	1.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Mouth or throat sore interference - Day -3	1.00 score on a scale Interval 1.0 to 1.0	1.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Mouth or throat sore interference - Day 8	1.00 score on a scale Interval 1.0 to 4.0	1.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Mouth or throat sore interference - date of discharge or Day 14 (whichever is sooner)	1.00 score on a scale Interval 1.0 to 1.0	1.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Decreased appetite interference - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Decreased appetite interference - Day 8	3.00 score on a scale Interval 1.0 to 5.0	3.50 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0 Decreased appetite interference - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 5.0	3.00 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)

* Questions regarding gastrointestinal toxicities * Responses are scored from 1-5 with 1=never and 5=almost constantly

Outcome measures

Outcome measures
Measure	Uproleselan + Standard of Care Melphalan n=25 Participants 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 n=24 Participants 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.
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of nausea - date of discharge or Day 14 (whichever is sooner)	3.00 score on a scale Interval 1.0 to 4.0	3.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of vomiting - Day -3	1.00 score on a scale Interval 1.0 to 1.0	1.00 score on a scale Interval 1.0 to 2.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of vomiting - Day 8	2.00 score on a scale Interval 1.0 to 4.0	2.50 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of vomiting - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 3.0	2.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of nausea - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of nausea - Day 8	4.00 score on a scale Interval 1.0 to 5.0	4.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of bowel incontinence - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 5.0	1.50 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of heartburn - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of heartburn - Day 8	1.00 score on a scale Interval 1.0 to 5.0	1.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of heartburn - date of discharge or Day 14 (whichever is sooner)	1.00 score on a scale Interval 1.0 to 3.0	1.50 score on a scale Interval 1.0 to 400.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of bloating - Day -3	1.00 score on a scale Interval 1.0 to 5.0	1.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of bloating - Day 8	2.00 score on a scale Interval 1.0 to 5.0	2.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of bloating - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 5.0	2.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of diarrhea - Day -3	1.00 score on a scale Interval 1.0 to 4.0	1.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of diarrhea - Day 8	4.00 score on a scale Interval 3.0 to 5.0	4.00 score on a scale Interval 2.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of diarrhea - date of discharge or Day 14 (whichever is sooner)	4.00 score on a scale Interval 1.0 to 5.0	4.00 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of abdominal pain - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 3.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of abdominal pain - Day 8	2.00 score on a scale Interval 1.0 to 5.0	2.50 score on a scale Interval 1.0 to 5.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of abdominal pain - date of discharge or Day 14 (whichever is sooner)	2.00 score on a scale Interval 1.0 to 4.0	2.00 score on a scale Interval 1.0 to 4.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of bowel incontinence - Day -3	1.00 score on a scale Interval 1.0 to 3.0	1.00 score on a scale Interval 1.0 to 2.0
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0 Frequency of bowel incontinence - Day 8	2.00 score on a scale Interval 1.0 to 4.0	1.00 score on a scale Interval 1.0 to 4.0

Adverse Events

Uproleselan + Standard of Care Melphalan

Serious events: 5 serious events

Other events: 26 other events

Deaths: 2 deaths

Placebo + Standard of Care Melphalan

Serious events: 5 serious events

Other events: 25 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Uproleselan + Standard of Care Melphalan n=26 participants at risk 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 n=25 participants at risk 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.
Gastrointestinal disorders Nausea	3.8% 1/26 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).	0.00% 0/25 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).
General disorders Fever	3.8% 1/26 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).	12.0% 3/25 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).
Infections and infestations Sinusitis	3.8% 1/26 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).	0.00% 0/25 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).
Infections and infestations Bacteremia	3.8% 1/26 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).	0.00% 0/25 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).
Infections and infestations Lung Infection	3.8% 1/26 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).	0.00% 0/25 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).
Infections and infestations Skin Infection	0.00% 0/26 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).	4.0% 1/25 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).
Infections and infestations Sepsis	0.00% 0/26 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).	4.0% 1/25 • Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).

Other adverse events

Additional Information

Keith Stockerl-Goldstein, M.D.

Washington University School of Medicine

Phone: 314-747-7859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Uproleselan + Standard of Care Melphalan n=26 Participants 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 n=24 Participants 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.
Change in Proctitis as Assessed Per CTCAE v5.0 Day -3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day -2	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day -1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 0	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 1	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 2	0.04 CTCAE grade Standard Deviation 0.20	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 3	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 4	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Proctitis as Assessed Per CTCAE v5.0 Day 5	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Proctitis as Assessed Per CTCAE v5.0 Day 6	0.12 CTCAE grade Standard Deviation 0.43	0.04 CTCAE grade Standard Deviation 0.20
Change in Proctitis as Assessed Per CTCAE v5.0 Day 7	0.00 CTCAE grade Standard Deviation 0.00	0.04 CTCAE grade Standard Deviation 0.20
Change in Proctitis as Assessed Per CTCAE v5.0 Day 8	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 9	0.08 CTCAE grade Standard Deviation 0.27	0.08 CTCAE grade Standard Deviation 0.41
Change in Proctitis as Assessed Per CTCAE v5.0 Day 10	0.08 CTCAE grade Standard Deviation 0.39	0.08 CTCAE grade Standard Deviation 0.41
Change in Proctitis as Assessed Per CTCAE v5.0 Day 11	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 12	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 13	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00
Change in Proctitis as Assessed Per CTCAE v5.0 Day 14	0.00 CTCAE grade Standard Deviation 0.00	0.00 CTCAE grade Standard Deviation 0.00