Melphalan, lenalidomide and dexamethasone for the treatment of immunoglobulin light chain amyloidosis: results of a phase II trial

Autor: Vaishali Sanchorawala, Jaymin M. Patel, J. Mark Sloan, Anthony C. Shelton, Jerome B. Zeldis, David C. Seldin
Jazyk: angličtina
Rok vydání: 2013
Předmět:
Zdroj: Haematologica, Vol 98, Iss 5 (2013)
Druh dokumentu: article
ISSN: 0390-6078
1592-8721
DOI: 10.3324/haematol.2012.075192
Popis: We report results of a phase II trial of combination of melphalan, lenalidomide, and dexamethasone for the treatment of immunoglobulin light chain (AL) amyloidosis. The primary objectives were tolerability and hematologic response rate; secondary objectives were organ responses and survival. Treatment protocol consisted of melphalan 5 mg/m2/day for four days, lenalidomide 10 mg/day for 21 days and dexamethasone 20–40 mg once a week every 28 days for a total of 12 cycles. Sixteen subjects were enrolled of whom 14 completed at least 3 cycles and were evaluable for response. Grade 3/4 toxicities were experienced by 88% (n=14), the most common being myelosuppression (n=7). Dose reductions occurred in 85% (n=12 of 14) of subjects. Hematologic partial and complete responses were achieved by 43% (n=6 of 14) and 7% (n=1 of 14), respectively. The median overall survival has not been reached and median progression-free survival is 24 months. In conclusion, this combination is associated with significant myelosuppression leading to dose modifications and producing minor hematologic responses in AL amyloidosis.http://clinicaltrials.gov/ct2/show/NCT00679367
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