In this multi-center phase III trial, untreated patients diagnosed with AL who are not
candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Stage
I and II patients will be eligible. Stage III patients will be enrolled in an ancillary phase
II study. Eligible patients will be stratified as cardiac stage I or stage II and then
randomized to receive MDex or BMDex.
Primary objective is to compare hematologic(clonal) response i.e. the rate of complete
response (CR) + partial response (PR) defined according to the criteria of the International
Society for Amyloidosis consensus.