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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06547112 | A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization | PHASE1 | COMPLETED | 20 | — | — | Oct 31, 2024 | Aug 19, 2025 | Aug 29, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Standard dosing | ACTIVE_COMPARATOR | For Cohort 1, motixafortide will be given on Day 4 between 6:00 and 8:00 pm. A second dose may be given on Day 6 between 6:00 and 8:00 p.m. if CD34+ cell collection goals are not met on Day 5 apheresis. |
| Cohort 2: Early dosing | EXPERIMENTAL | For Cohort 2, motixafortide will be given on Day 4 between 2:00 and 4:00 pm. A second dose may be given on Day 6 with goal of administration between 6:00 and 8:00 pm after completion of pheresis if clinically feasible. if CD34+ cell collection goals are not met on Day 5 apheresis. |
| Name | Type | Description |
|---|---|---|
| Motixafortide | DRUG | Dose = 1.25 mg/kg via subcutaneous injection |
| G-CSF | DRUG | Dose = \~10 µg/kg (and maximum of 15 µg/kg) via subcutaneous injection |
Inclusion Criteria: * Subjects must be between the ages of 18 and 78 years, inclusive. * Histologically confirmed multiple myeloma expected to receive high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT) * Received ≥3 cycles but ≤6 cycles of daratumumab-based quadruplet indu...