Trials / Terminated
TerminatedNCT04412707
A PK, Safety and Tolerability Study of Peripheral and Central Infusion of Melflufen in RRMM Patients
A Randomized, Two-period, Cross-over, Phase 2 Study, Comparing Pharmacokinetics, and Assessing Safety and Tolerability of Peripheral and Central i.v. Administration of Melphalan Flufenamide (Melflufen) in RRMM Patients
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Oncopeptides AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Melphalan | Peripheral versus central administration |
| DRUG | Dexamethasone | Oral tablets |
Timeline
- Start date
- 2020-08-04
- Primary completion
- 2021-06-02
- Completion
- 2022-01-10
- First posted
- 2020-06-02
- Last updated
- 2023-03-09
- Results posted
- 2022-08-16
Locations
10 sites across 5 countries: United States, Bulgaria, Czechia, Hungary, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04412707. Inclusion in this directory is not an endorsement.