drugset / Trial / NCT05438394
Clinical Study of Safety and Tolerability of Melphalan Hydrochloride for R/R MM
NaSingle-groupOpen-labelTreatment
Summary
This study is an investigator-initiated clinical study to evaluate the safety and tolerability of melphalan hydrochloride for injection in patients with relapsed or relapsed refractory multiple myeloma. Using the "3 + 3" dose escalation principle, 3-6 subjects per dose were enrolled, depending on the dose limiting toxicity (DLT) observed in the first cycle of chemotherapy for each subject. After completing the 21-day assessment of the first cycle of chemotherapy, if there was no DLT, the study started for the next dose group.
Timeline
- Start
- 2022-10-13
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | 9 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 18 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 27 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 40 mg/m2 | Intravenous |