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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day -3, day +8, date of discharge or day +14 (whichever is sooner) (up to 18 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -3, day +8, date of discharge or day +14 (whichever is sooner) (up to 18 days)
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 moreTrial 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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