A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis
Stopped early · Phase 1
Conditions studied: AL Amyloidosis
In brief
This is a phase 1/2 open label study of melphalan flufenamide (melflufen) in combination with dexamethasone for participants with Al amyloidosis following at least one prior line of therapy. Melflufen will be administered on Day 1 of each 28-day cycle in combination with dexamethasone on days 1 and 2. In both phases, treatment of each individual participant will continue for up to 8 cycles or until any stopping events occur. Approximately 46 participants will be enrolled. The study was intended to be a Phase 1/2 trial but was early terminated and never moved forward to Phase 2.
Key facts
- Study ID
- NCT04115956
- Run by
- Oncopeptides AB
- People needed
- 6
- Starts
- 2020-08-06
- Expected to finish
- 2022-01-05
- Last updated by the study team
- 2022-03-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Boston University Medical Center — Boston, Massachusetts, United States
- Fakultní Nemocnice Ostrava — Ostrava - Poruba, Czechia
- Centre Hospitalier Universitaire de Limoges — Limoges, France
- Universitätsklinikum Heidelberg — Heidelberg, Germany
- Alexandra General Hospital of Athens — Athens, Greece
- Hadassah University Hospital Ein Kerem — Jerusalem, Israel
- Oslo University Hospital - Rikshospitalet — Oslo, Norway
- Hospital Clinic de Barcelona — Barcelona, Spain
- University College London Hospitals NHS Foundation Trust — London, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.