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

NCT04115956 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-03-28

No results posted yet for this study

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.

The study was intended to be a Phase 1/2 trial but was early terminated and never moved forward to Phase 2.

Conditions

  • AL Amyloidosis

Interventions

DRUG

Melphalan-Flufenamide (Melflufen)

Treatment consist of i.v. melflufen on Day 1 of each 28-day cycle.

DRUG

Dexamethasone

Dexamethasone 40 mg (20 mg at investigator's discretion) administered on Days 1 and 2 of each 28-day cycle.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Oncopeptides AB

    lead INDUSTRY

Principal Investigators

  • Giovanni Palladini, MD · University Hospital San Matteo in Pavia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2022-01-05
Completion
2022-01-05
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Greece
  • Israel
  • Norway
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115956 on ClinicalTrials.gov