A phase II trial of lenalidomide, dexamethasone and cyclophosphamide for newly diagnosed patients with systemic immunoglobulin light chain amyloidosis.

Abstract

Immunomodulatory drugs have been shown to be of benefit in relapsed/refractory immunoglobulin light-chain (AL) amyloidosis. We designed a prospective, multicentre phase II trial of lenalidomide, dexamethasone and cyclophosphamide for newly diagnosed patients with AL amyloidosis not eligible for autologous stem-cell transplantation. Twenty-eight patients were included in the study. Cardiac involvement was present in 23 patients; 14 of them had cardiac stage III. The overall haematological response rate was 46%, including complete and very good partial responses in 25% and 18% of patients respectively. Haematological response was mainly associated with absence of cardiac stage III and lower tumour burden. Organ response was observed in 46% of patients. After a median follow-up of 24 months, median progression-free and overall survival have not been reached, both being significantly longer in responders (P < 0·001 and P = 0·001 respectively). Seventeen patients have discontinued treatment, mostly due to amyloid-related death, disease progression or lack of response. Only 14% of the patients discontinued treatment due to therapy-related adverse events. Our results support the efficacy of this regimen, with high quality responses and prolonged survival, as well as its tolerability, in patients with AL amyloidosis not eligible for stem cell transplant and without advanced cardiac involvement (clinicaltrials.gov identifier: NCT01194791).

• Authors: Maria T Cibeira, Albert Oriol, Juan J Lahuerta, Maria-Victoria Mateos, Javier de la Rubia, Miguel T Hernández, Miquel Granell, Carlos Fernández de Larrea, Jesús F San Miguel, Joan Bladé, PETHEMA cooperative study group
• Journal: British journal of haematology (Br J Haematol) Vol. 170 Issue 6 Pg. 804-13 (Sep 2015) ISSN: 1365-2141 [Electronic] England
• PMID: 25974382 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 John Wiley & Sons Ltd.

Chemical References

• Immunoglobulin Light Chains
• Thalidomide
• Dexamethasone
• Cyclophosphamide
• Lenalidomide

Topics

• Aged
• Aged, 80 and over
• Amyloidosis (diagnosis, drug therapy, metabolism, mortality)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Cyclophosphamide (administration & dosage)
• Dexamethasone (administration & dosage)
• Disease Progression
• Female
• Humans
• Immunoglobulin Light Chains (metabolism)
• Lenalidomide
• Male
• Middle Aged
• Survival Analysis
• Thalidomide (administration & dosage, analogs & derivatives)
• Treatment Outcome