A real‐life study of daratumumab combinations in newly diagnosed patients with light chain (AL) amyloidosis

• Published in: Hematological oncology Vol. 42; no. 4; pp. e3289 - n/a
• Main Authors: Bellofiore, Claudia, Benvenuti, Pietro, Mina, Roberto, Basset, Marco, Foli, Andrea, Nanci, Martina, Nuvolone, Mario, Guida, Gianluigi, Attanasio, Andrea, Mussinelli, Roberta, Mangiacavalli, Silvia, Cartia, Claudio Salvatore, Masoni, Valeria, Palumbo, Michele, Cani, Lorenzo, Oliva, Stefania, Consoli, Ugo, Conticello, Concetta, Di Raimondo, Francesco, Arcaini, Luca, Bringhen, Sara, Merlini, Giampaolo, Palladini, Giovanni, Milani, Paolo
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.07.2024
• Subjects: Adult; Aged; Aged, 80 and over; AL amyloidosis; Amyloidosis; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bortezomib; Bortezomib - administration & dosage; Bortezomib - adverse effects; Bortezomib - therapeutic use; cardiac staging; daratumumab; Effectiveness; Female; Heart rate; Humans; Immunoglobulin Light-chain Amyloidosis - diagnosis; Immunoglobulin Light-chain Amyloidosis - drug therapy; Immunotherapy; Inhibitor drugs; Lenalidomide - administration & dosage; Lenalidomide - adverse effects; Lenalidomide - therapeutic use; Male; Middle Aged; Monoclonal antibodies; Myeloma; Observational studies; prognosis; Prospective Studies; Targeted cancer therapy; Treatment Outcome; AL amyloidosis; cardiac staging; daratumumab; prognosis
• DOI: 10.1002/hon.3289
• ISSN: 0278-0232; 1099-1069

Daratumumab‐based regimens are the new standard of care for newly diagnosed patients with AL amyloidosis based on the results of the ANDROMEDA study. However, real‐world data on daratumumab efficacy in upfront therapy in unselected patients are scanty. In the framework of a prospective observational study, we investigated the efficacy and safety of daratumumab in 88 newly diagnosed patients, including subjects with IIIb cardiac stage (26%) or myeloma defining events (29%). Daratumumab was administered with bortezomib in 50 (56%) patients, lenalidomide in 31 (35%), and monotherapy in 7 (8%). The rate of serious adverse events was low (16%). The overall hematologic response rate was 75% with 52 (59%) patients attaining at least a very good partial response (VGPR) at six months. Amongst patients evaluable for organ response, the rate of cardiac and renal responses at 6 months was 31% and 21%, respectively. Comparing stage IIIb patients with the remaining ones, the rate of profound hematologic response was not significantly different (≥VGPR 57% vs. 59%, p 0.955) likewise the rate of cardiac (33% vs. 30%, p 0.340) and renal (40% vs. 16%, p 0.908) responses. Daratumumab‐based regimens demonstrated to be safe and effective in treatment‐naïve AL amyloidosis even in advanced stage disease.