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Uproleselan for Multiple Myeloma

Phase 2
Waitlist Available
Led By Keith Stockerl-Goldstein, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing first auto-HCT for MM in first partial response (PR) or better
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -3, day +8, date of discharge or day +14 (whichever is sooner) (up to 18 days)
Awards & highlights

Study Summary

This trial is testing a drug that may reduce side effects from a cancer treatment while also making the treatment more effective.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -3, day +8, date of discharge or day +14 (whichever is sooner) (up to 18 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -3, day +8, date of discharge or day +14 (whichever is sooner) (up to 18 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Diarrhea as Assessed Per CTCAE v5.0
Secondary outcome measures
Change in Abdominal Pain as Assessed Per CTCAE v5.0
Change in Bristol Stool Scale
Change in Enterocolitis as Assessed Per CTCAE v5.0
+19 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Uproleselan + Standard of Care MelphalanExperimental Treatment2 Interventions
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
Group II: Placebo + Standard of Care MelphalanPlacebo Group2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Uproleselan
2018
Completed Phase 2
~60
Melphalan
2008
Completed Phase 3
~1500

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,912 Total Patients Enrolled
30 Trials studying Multiple Myeloma
1,176 Patients Enrolled for Multiple Myeloma
GlycoMimetics IncorporatedIndustry Sponsor
22 Previous Clinical Trials
1,461 Total Patients Enrolled
1 Trials studying Multiple Myeloma
10 Patients Enrolled for Multiple Myeloma
The Foundation for Barnes-Jewish HospitalOTHER
36 Previous Clinical Trials
5,794 Total Patients Enrolled

Frequently Asked Questions

~13 spots leftby Mar 2025