Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04682405 | Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM) | PHASE2 | COMPLETED | 51 | — | — | May 5, 2021 | Nov 11, 2022 | Dec 15, 2023 | 1 | United States |
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.
| 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 |
| 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...