Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During... | NCT04682405

Name	Class
GlycoMimetics Incorporated	INDUSTRY
The Foundation for Barnes-Jewish Hospital	OTHER

Label	Type	Description	Intervention Names
Uproleselan + Standard of Care Melphalan	Experimental	On the evening of Day -3, patients will receive dose #1 of uproleselan On the following morning of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #2 of uproleselan On the evening of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #3 of uproleselan On Day -2 following completion of dose #3 of uproleselan, the patient will be administered the conditioning dose of melphalan (200mg/m^2) as per institutional practice. On the following morning of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #4 of uproleselan On the evening of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #5 of uproleselan On the following morning of Day 0 (12 +/- 2 hours from prior dose) patients will receive dose #6 (final dose) of uproleselan On Day 0, 4 hours (+/- 2 hours) after the final dose of uproleselan, the patient will be infused with the HSC product. The patient will remain inpatient until engraftment	Drug: Uproleselan Drug: Melphalan
Placebo + Standard of Care Melphalan	Placebo Comparator	On the evening of Day -3, patients will receive dose #1 of placebo On the following morning of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #2 of placebo On the evening of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #3 of placebo. On Day -2 following completion of dose #3 of placebo, the patient will be administered the conditioning dose of melphalan (200mg/m^2) as per institutional practice. On the following morning of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #4 of placebo. On the evening of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #5 of placebo. On the following morning of Day 0 (12 +/- 2 hours from prior dose) patients will receive dose #6 (final dose) of placebo. On Day 0, 4 hours (+/- 2 hours) after the final dose of placebo, the patient will be infused with the HSC product. The patient will remain inpatient until engraftment	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Uproleselan	Drug	Provided by study	Uproleselan + Standard of Care Melphalan

Measure	Description	Time Frame
Change in Diarrhea as Assessed Per CTCAE v5.0	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.	From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Measure	Description	Time Frame
Change in Oral Mucositis as Assessed Per CTCAE v5.0	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy-confirmed multiple myeloma (MM) (per IMWG criteria).
Undergoing first auto-HCT for MM in first partial response (PR) or better
Conditioning regimen to be single agent melphalan (200 mg/m^2)
Adults 18 to 75 years of age, inclusive
ECOG performance status ≤ 2
Mobilized ≥ 5.0 x 10^6 CD34+ cells/kg (i.e. sufficient CD34+ HSCs for one auto-HCT, with at least one back-up graft in reserve)
Adequate bone marrow and organ function prior to stem cell mobilization as defined below:
- Leukocytes, absolute neutrophil count, and platelets within institutional standard limits for high-dose melphalan autologous stem cell transplant
- Total bilirubin ≤ 1.5 x ULN (unless the patient has a history of Gilbert's Syndrome, in which case, total bilirubin must be ≤ 2.5 times the ULN)
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x ULN
- Creatinine clearance ≥ 30 mL/min by Cockcroft-Gault
- Baseline pulmonary function test (PFT) with carbon monoxide diffusion capacity in the lung (DLCO) ≥ 50% and forced expiratory volume in 1 second (FEV1) both within institutional standard limits for high-dose melphalan autologous stem cell transplant
The effects of uproleselan (GMI-1271) on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, prior sterilization procedure, abstinence, etc.) prior to study entry, for the duration of study participation and for 12 weeks after the completion of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Should a man who is participating in the study become aware that he has impregnated a partner, he must inform his treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
Active signs or symptoms of CNS involvement by malignancy (lumbar puncture not required). Prior history of CNS involvement is acceptable, if patient has completed treatment for CNS involvement with documented treatment response.
Prior exposure to uproleselan (GMI-1271)
Currently receiving any other investigational agents
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to uproleselan or melphalan
Known active infection with hepatitis A, B (e.g., HBsAg positive), or C (e.g., anti-HCV positive), or human immunodeficiency virus
Uncontrolled acute life-threatening bacterial, viral, or fungal infection-Myocardial infarction within 6 months of uproleselan/placebo dosing, or subject has current significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hemodynamic instability, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Any medical, psychiatric, or other condition which, in the opinion of the investigator, unfavorably alters the risk-benefit of subject participation, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.
Pregnant and/or breastfeeding.
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during the trial and for 12 weeks following the last dose of uproleselan/placebo. Women who are postmenopausal with amenorrhea for at least 1 year prior to trial entry and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status (>28U/L) will be considered NOT of childbearing potential. Highly effective contraception includes:
- Total abstinence with a male partner.
- Female sterilization (has had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before uproleselan/placebo. In case of oophorectomy alone, the subject would be eligible only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 months prior to Screening). For female subjects on the trial, the vasectomized male partner should be the sole partner for that subject.
- BOTH of the following forms of contraception consistently used together:
  - Injected, transdermal, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%) with the exception of intrauterine devices, which are excluded due to the risk of infection and bleeding.
  - Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with or without spermicidal foam/gel/film/cream/vaginal suppository.
  - Men who are sexually active and not willing to use condoms during the trial and for 12 weeks following the last dose of uproleselan/placebo, unless they have undergone vasectomy for sterilization (at least 6 months prior to Screening), are excluded from trial participation.
Men who are sexually active and not willing to use condoms during the trial and for 12 weeks following the last dose of uproleselan/placebo, unless they have undergone vasectomy for sterilization (at least 6 months prior to Screening), are excluded from trial participation.

Name	Affiliation	Role
Keith Stockerl-Goldstein, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 22, 2022

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00026 BG00125 BG00251

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Diarrhea as Assessed Per CTCAE v5.0

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.

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00026 OG00124

Title

Denominators

Categories

Day -3

- ParticipantsOG00025
- ParticipantsOG00124

Title	Measurements
	OG0000.00± 0.00

Secondary

Change in Oral Mucositis as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Esophagitis as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Gastritis as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Esophageal Pain as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Abdominal Pain as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Nausea as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Vomiting as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Enterocolitis as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Proctitis as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Hemorrhoids as Assessed Per CTCAE v5.0

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.

Posted

Mean

Standard Deviation

CTCAE grade

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Time to Neutrophil Engraftment

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

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.

Posted

Mean

Standard Deviation

Days

Through date of discharge (up to be 18 days)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Change in Nutritional Status as Assessed by Total Parenteral Nutrition (TPN) Days

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.

Posted

Mean

Standard Deviation

Days

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Duration of Hospital Length of Stay

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.

Posted

Mean

Standard Deviation

Days

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change in Bristol Stool Scale

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Nutritional Status as Assessed by Change in Standing Weight

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

Posted

Mean

Standard Deviation

kilograms

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Incidence of Infection Assessed by Rates of Bacteremia (With Organism Reported When Available)

Posted

Count of Participants

Participants

Through date of discharge (upto be 18 days)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Time to First Antibiotics

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

Posted

Median

Full Range

days

Through date of discharge (up to be day 18)

ID	Title	Description
OG000	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.
OG001	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.

Units

Secondary

Incidence of Clostridium Difficile Infections

Posted

Count of Participants

Participants

Through date of discharge (up to be 18 days)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Median Daily Dose of Anti-diarrheal Medications

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

Posted

Median

Full Range

number of doses in one day

Through date of discharge (up to be 18 days)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Daily Dose of Pain Medications

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

Posted

Median

Full Range

mg morphine equivalents

Through date of discharge (up to be 18 days)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0

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

Posted

Median

Full Range

score on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0

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

Posted

Median

Full Range

score on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0

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

Posted

Median

Full Range

score on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment		EG00025 affected26 at risk EG00125 affected25 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0014 affected25 at risk
Sinus Tachycardia	Cardiac disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Supraventricular Tachycardia	Cardiac disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Ear Pain	Ear and labyrinth disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Adrenal Insufficiency	Endocrine disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Eye Disorders - other	Eye disorders	CTCAE (Unspecified)	Systematic Assessment	Diplopia; estropia; right eye conjunctional hemorrhage	EG0003 affected26 at risk EG0010 affected25 at risk
Blurred Vision	Eye disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Extraocular Muscle Paresis	Eye disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Periorbital Edema	Eye disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0010 affected25 at risk
Photophobia	Eye disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Vision Decreased	Eye disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Gastrointestinal Disorders - other	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment	diverticulitis	EG0000 affected26 at risk EG0011 affected25 at risk
Abdominal Pain	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG00021 affected26 at risk EG00118 affected25 at risk
Bloating	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0011 affected25 at risk
Colitis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Constipation	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0009 affected26 at risk EG0015 affected25 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG00026 affected26 at risk EG00124 affected25 at risk
Dry Mouth	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Dysphagia	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Enterocolitis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0009 affected26 at risk EG0017 affected25 at risk
Esophageal Pain	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG00013 affected26 at risk EG00110 affected25 at risk
Esophagitis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG00010 affected26 at risk EG0017 affected25 at risk
Flatulence	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0010 affected25 at risk
Gastric Hemorrhage	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Gastritis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0006 affected26 at risk EG0014 affected25 at risk
Gastroesophageal Reflux Disease	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0003 affected26 at risk EG0011 affected25 at risk
Hemorrhoids	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0005 affected26 at risk EG0013 affected25 at risk
Mucositis oral	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG00013 affected26 at risk EG0018 affected25 at risk
Nausea	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG00025 affected26 at risk EG00124 affected25 at risk
Oral Pain	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Proctitis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0004 affected26 at risk EG0012 affected25 at risk
Toothache	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Typhlitis	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Vomiting	Gastrointestinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG00017 affected26 at risk EG00120 affected25 at risk
Localized Edema	General disorders	CTCAE (Unspecified)	Systematic Assessment	Ear	EG0001 affected26 at risk EG0010 affected25 at risk
Chills	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0012 affected25 at risk
Edema Limbs	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0004 affected26 at risk EG0015 affected25 at risk
Facial Pain	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Fatigue	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG00023 affected26 at risk EG00120 affected25 at risk
Fever	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0009 affected26 at risk EG00111 affected25 at risk
Generalized Edema	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Infusion Site Extravasation	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0010 affected25 at risk
Malaise	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0009 affected26 at risk EG0017 affected25 at risk
Neck Edema	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Non-cardiac Chest Pain	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Pain	General disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Allergic Reaction	Immune system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0012 affected25 at risk
Infections and Infestations - other	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment	Klebsiella pneumoniae; MSSA/Staph lugdunensis; Streptococcus salivarius; Streptococcus dysgalactiae; viral dermatitis; herpes simplex virus; Klebsiella pneumoniae bacteremia	EG0003 affected26 at risk EG0013 affected25 at risk
Bacteremia	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0012 affected25 at risk
Enterocolitis Infectious	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0003 affected26 at risk EG0011 affected25 at risk
Folliculitis	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Lung Infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Otitis Externa	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Papulopustular Rash	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Sepsis	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0012 affected25 at risk
Skin Infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0003 affected26 at risk EG0011 affected25 at risk
Thrush	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0007 affected26 at risk EG0017 affected25 at risk
Urinary Tract Infection	Infections and infestations	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Bruising	Injury, poisoning and procedural complications	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0011 affected25 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0012 affected25 at risk
Activated partial thromboplastin time prolonged	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG0003 affected26 at risk EG0013 affected25 at risk
Alanine aminotransferase increased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG0003 affected26 at risk EG0014 affected25 at risk
Alkaline phosphatase increased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0013 affected25 at risk
Blood bilirubin increased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG0003 affected26 at risk EG0011 affected25 at risk
Creatinine increased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0013 affected25 at risk
INR increased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG00021 affected26 at risk EG00110 affected25 at risk
Lymphocyte count decreased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG00024 affected26 at risk EG00124 affected25 at risk
Lymphocyte count increased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Neutrophil count decreased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG00026 affected26 at risk EG00124 affected25 at risk
Platelet count decreased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG00026 affected26 at risk EG00123 affected25 at risk
White blood cell decreased	Investigations	CTCAE (Unspecified)	Systematic Assessment		EG00026 affected26 at risk EG00125 affected25 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0004 affected26 at risk EG0018 affected25 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0003 affected26 at risk EG0012 affected25 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0003 affected26 at risk EG0015 affected25 at risk
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Hypermagnesemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0014 affected25 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0016 affected25 at risk
Hyperphosphatemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0011 affected25 at risk
Hyperuricemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG00023 affected26 at risk EG00123 affected25 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG00026 affected26 at risk EG00122 affected25 at risk
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0010 affected25 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG00018 affected26 at risk EG00119 affected25 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0013 affected25 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG0008 affected26 at risk EG0013 affected25 at risk
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment		EG00021 affected26 at risk EG00120 affected25 at risk
Musculoskeletal and Connective Tissue Disorder - other	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment	Ankle pain; bilateral shoulder pain; groin pain; hip pain; knee pain; thumb weakness	EG0003 affected26 at risk EG0013 affected25 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Back Pain	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment		EG0005 affected26 at risk EG0013 affected25 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0012 affected25 at risk
Generalized Muscle Weakness	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0011 affected25 at risk
Muscle Cramp	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0013 affected25 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0013 affected25 at risk
Neoplasms benign, malignant, and unspecified (incl cysts and polyps) - other	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Nervous System Disorders - other	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment	"tastes buds"; numbness around mouth; Restless Leg Syndrome; Taste	EG0001 affected26 at risk EG0012 affected25 at risk
Dizziness	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0006 affected26 at risk EG0016 affected25 at risk
Dysgeusia	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0012 affected25 at risk
Encephalopathy	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Headache	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0016 affected25 at risk
Lethargy	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Paresthesia	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0014 affected25 at risk
Presyncope	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0012 affected25 at risk
Tremor	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0012 affected25 at risk
Vasovagal Reaction	Nervous system disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Psychiatric Disorders - other	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment	AMS - altered mental status	EG0001 affected26 at risk EG0010 affected25 at risk
Agitation	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Anxiety	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0012 affected25 at risk
Confusion	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Delirium	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Hallucinations	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Insomnia	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0012 affected25 at risk
Restlessness	Psychiatric disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Dysuria	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0015 affected25 at risk
Hematuria	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Urinary Retention	Renal and urinary disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Reproductive System and Breast Disorders - other	Reproductive system and breast disorders	CTCAE (Unspecified)	Systematic Assessment	Vaginal bleeding	EG0000 affected26 at risk EG0011 affected25 at risk
Testicular Pain	Reproductive system and breast disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk
Respiratory, Thoracic, and Mediastinal Disorders - other	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment	winded	EG0001 affected26 at risk EG0010 affected25 at risk
Allergic Rhinitis	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0014 affected25 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0014 affected25 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0014 affected25 at risk
Postnasal Drip	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Sinus Pain	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Sore Throat	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0012 affected25 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Systematic Assessment		EG0002 affected26 at risk EG0012 affected25 at risk
Skin and Subcutaneous Tissue Disorders - other	Skin and subcutaneous tissue disorders	CTCAE (Unspecified)	Systematic Assessment	lump; multiple scattered moles/lesions on chest	EG0002 affected26 at risk EG0010 affected25 at risk
Rash Maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk
Hot Flashes	Vascular disorders	CTCAE (Unspecified)	Systematic Assessment		EG0000 affected26 at risk EG0013 affected25 at risk
Hypertension	Vascular disorders	CTCAE (Unspecified)	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk
Hypotension	Vascular disorders	CTCAE (Unspecified)	Systematic Assessment		EG0008 affected26 at risk EG0014 affected25 at risk

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D010649	Phenylalanine
D024322	Amino Acids, Aromatic
D000598	Amino Acids, Cyclic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	2	26	5	26	26	26
EG001	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.	3	25	5	25	25	25