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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Up to 6 cycles of oral L-Mel-Dex, every 28 days Revlimid® 10 mg daily for 21 days, (add on therapy), Melphalan 0.15 mg/kg/day day 1-4, Dexamethasone 20 mg day 1-4
University Clinic Heidelberg
Heidelberg, Germany
Complete response (CR) rate
Time frame: 6 months: after 6 cycles of L-Mel-Dex
Rate of hematological response (CR and PR)
Time frame: 6 months
Organ response rate
Time frame: 3 months after discontinuation of L-Mel_Dex (maximum: 9 months)
Correlation of cytogenetic aberrations and gene expression profiling (GEP) results with best hematological response to treatment
Time frame: 6 months
Retrospective comparison with a historical control group treated with Mel-Dex in our institution
Time frame: 01.04.2012
Toxicity (hematological and non-hematological)
Time frame: 6 months
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