A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
The treatment with oral melphalan and prednisone has been recommended as standard treatment
of AL amyloidosis but the results are rather disappointing. Another therapeutic option is
pulsed high-dose dexamethasone + melphalan (Mel-Dex) with more encouraging results regarding
the achievement of a faster disease response and higher rates of haematological remission. In
the last 5 - 10 years, promising treatment outcomes after therapy with high-dose melphalan
and autologous stem cell support have been reported by several groups but only highly
selected patients are eligible for this treatment. Lenalidomide has been shown to be
effective in phase II and III trials in MM patients. Because of the relationship to MM,
Lenalidomide is a promising therapeutic option also for patients with AL amyloidosis. The
addition of Lenalidomide to Mel-Dex could improve rate of complete response (CR) and organ
response in patients not eligible for or refused high-dose chemotherapy.
Phase:
Phase 2
Details
Lead Sponsor:
Heidelberg University
Collaborator:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH