A phase II trial of cyclophosphamide, lenalidomide and dexamethasone in previously treated patients with AL amyloidosis
Giovanni Palladini,
Paola Russo,
Paolo Milani,
Andrea Foli,
Francesca Lavatelli,
Mario Nuvolone,
Stefano Perlini,
Giampaolo Merlini
Affiliations
Giovanni Palladini
Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, ItalyDepartment of Molecular Medicine, University of Pavia, Pavia, Italy
Paola Russo
Transfusion Medicine Service, Melegnano Hospital, Vizzolo Predabissi, ItalyDept. of Computer Engineering and System Science, University of Pavia, Pavia, Italy
Paolo Milani
Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, ItalyDepartment of Molecular Medicine, University of Pavia, Pavia, Italy
Andrea Foli
Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, ItalyDepartment of Molecular Medicine, University of Pavia, Pavia, Italy
Francesca Lavatelli
Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, ItalyDepartment of Molecular Medicine, University of Pavia, Pavia, Italy
Mario Nuvolone
Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, ItalyDepartment of Molecular Medicine, University of Pavia, Pavia, Italy
Stefano Perlini
Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, ItalyDepartment of Molecular Medicine, University of Pavia, Pavia, Italy;Department of Internal Medicine, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Italy
Giampaolo Merlini
Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, ItalyDepartment of Molecular Medicine, University of Pavia, Pavia, Italy
Immune-modulatory drugs are active in immunoglobulin light-chain amyloidosis and the addition of alkylating agents can potentiate their action. In this phase II prospective trial we used cyclophosphamide, lenalidomide and dexamethasone in the treatment of 21 patients who were refractory (n=13, 62%) or relapsed (n=8, 38%) after prior treatment including melphalan in all cases, bortezomib in 4 and thalidomide in 6. Median number of cycles administered was 4 (range 2–9 cycles). Severe adverse events were observed in 57% of patients, most common being neutropenia (29%). The hematologic response rate was 62%, with one complete response and 5 very good partial responses. Overall median survival was three years. The achievement of CR/VGPR was associated with a significant survival advantage. The combination of cyclophosphamide, lenalidomide and dexamethasone is an effective treatment for relapsed/refractory AL amyloidosis, and good quality hematologic response should be the aim of treatment in this setting.(clinicaltrials.gov identifier: NCT00607581)
