Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Uproleselan · 2 trials · 2 indications
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.
Urine and feces will be collected at different time points and the radioactivity will be measured. The recovery will be expressed as percentage of radioactivity administered
The time from dosing at which Cmax was apparent
maximum observed concentration
area under the curve from 0 time to last measurable concentration
area under the curve from 0 time extrapolated to infinity
percentage of AUC(0-inf) extrapolated beyond last measured time point
the apparent elimination rate constant
the apparent elimination half-life
clearance, the apparent volume cleared of parent drug per unit time after intravenous administration
the apparent volume of distribution after intravenous administration
mean residence time
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
renal clearance: the apparent volume of plasma cleared of Uproleselan per unit time via renal elimination, calculated as: CLr = Ae (urine) / AUC
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Single IV administration of [14C]-Uproleselan | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Uproleselan | DRUG | Provided by study |
| Placebo | DRUG | Provided by study |
| Melphalan | DRUG | -Standard of care |
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 * M...
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Uproleselan is an investigational small molecule being studied in healthy subjects and in patients with multiple myeloma. In multiple myeloma, it is being evaluated for gastrointestinal toxicity prophylaxis during melphalan-conditioned autologous hematopoietic cell transplantation. It is not approved and remains in clinical development.
Uproleselan is being developed by GlycoMimetics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GLYC. The company is conducting clinical trials of the drug in healthy volunteers and in patients with multiple myeloma.
Uproleselan is in clinical development. A Phase 1 study in healthy subjects has been completed, and a Phase 2 study in multiple myeloma has also been completed. The drug is investigational and has not been approved by regulatory authorities.
Uproleselan has been studied in two completed clinical trials. NCT03606447 was a Phase 1 study in healthy male volunteers in the United Kingdom. NCT04682405 was a Phase 2 study in patients with multiple myeloma in the United States, evaluating the drug for gastrointestinal toxicity prophylaxis during autologous hematopoietic cell transplantation.
Yes, Uproleselan is also known as GMI-1271. The Phase 2 clinical trial in multiple myeloma, NCT04682405, refers to the drug as Uproleselan (GMI-1271), confirming that these names refer to the same investigational compound.