Overview

A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis

Status:
Active, not recruiting

Trial end date:
2024-04-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Oncopeptides AB

Collaborator:

PRA Health Sciences

Treatments:

BB 1101
Dexamethasone
Dexamethasone acetate
Melphalan