drugset / Trial / NCT04412707
A PK, Safety and Tolerability Study of Peripheral and Central Infusion of Melflufen in RRMM Patients
RandomizedCrossoverOpen-labelTreatment
Summary
This is a randomized, two-period, cross-over Phase 2 study, comparing PK, and assessing safety and tolerability and efficacy of peripheral and central intravenous administration of melflufen in patients with RRMM. It is an international study, enrolling patients in US and Europe. The study will enroll patients following at least 2 lines of prior therapy.
Timeline
- Start
- 2020-08-04
- Primary completion
- 2021-06-02
- Completion
- 2022-01-10
Outcome
Outcome not reported
Stopped: “The sponsor decided to terminate the study following an FDA request of a partial clinical hold.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melphalan | Small molecule | 40 mg | Intravenous |
| Comparator | Dexamethasone | Small molecule | 20 mg | — |
| Comparator | Dexamethasone | Small molecule | 40 mg | — |
Indications
No indication recorded.