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1.
Department of Molecular Medicine, University of Pavia, Pavia, Italy.
Authors
Bellofiore C
1,
2,
5
Nanci M
1,
2
Nuvolone M
1,
2
Arcaini L
1,
4
Merlini G
1,
2
Palladini G
1,
2
Milani P
1,
2
(7 authors)
2.
Amyloidosis Research and Treatment Centre, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy.
Authors
Bellofiore C
1,
2,
5
Benvenuti P
2
Basset M
2
Foli A
2
Nanci M
1,
2
Nuvolone M
1,
2
Guida G
2
Attanasio A
2
Mussinelli R
2
Merlini G
1,
2
Palladini G
1,
2
Milani P
1,
2
(12 authors)
3.
Division of Haematology, University of Torino, Torino, Italy.
Authors
Mina R
3
Cani L
3
Oliva S
3
Bringhen S
3
(4 authors)
4.
Division of Haematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Authors
Mangiacavalli S
4
Cartia CS
4
Masoni V
4
Palumbo M
4
Arcaini L
1,
4
(5 authors)
5.
Hematology Unit, ARNAS Garibaldi, Catania, Italy.
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Abstract
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.