MDex vs BMDex in systemic light-chain (AL) amyloidosis
Research type
Research Study
Full title
A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis
IRAS ID
80251
Contact name
Phillip Hawkins
Contact email
Sponsor organisation
Eramus University Hospital
Eudract number
2010-022395-31
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to compare two different chemotherapy treatment regimens for patients with systemic light-chain amyloidosis (AL) who are not appropriate for stem cell transplant or who have declined the procedure. The first regimen of oral melphalan and dexamethasone (MDex)is the current standard therapy. This will be compared with melphalan and dexamethasone given together with bortezomib (BMDex). Bortezomib has previously been demonstrated to have a high level of activity in AL when combined with dexamethasone, and possibly even higer levels of activity with combined with melphalan or cyclophoshamide. This is a multi-centre pan-European randomised open-label phase III trial, in which 110 participants will be randomised to treatment with either MDex or BMDex given up to 9 cycles. Participants will be stratified in accordance with the stage of cardiac involvement. The primary objective is to compare the haematologic response (either complete response or partial response) of the two groups after three cycles of treatment. Other objectives include comparison of response at the end of treatment, organ response rates, mortality and toxicity,quality of life and overall and progression-free survival.
REC name
London - Hampstead Research Ethics Committee
REC reference
11/LO/1804
Date of REC Opinion
26 Apr 2012
REC opinion
Further Information Favourable Opinion