• Tamir Shragai, Moshe Gatt, Noa Lavie, Iuliana Vaxman, Tamar Tadmor, Ory Rouvio, Miri Zektser, Nethanel Horowitz, Hila Magen, Mouna Ballan, Celia Suru, Efrat Luttwak, Shai Levi, Tomer Ziv-Baran, Irit Avivi, and Yael C Cohen.
• Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.
• Eur. J. Haematol. 2021 Feb 1; 106 (2): 184-195.

ObjectivesPatients with relapsed/refractory AL amyloidosis (RRAL) have poor prognosis, but emerging data shows promising results with the use daratumumab. We evaluated daratumumab treatment in RRAL in real-world setting.MethodsA retrospective multisite study of RRAL patients treated with daratumumab alone and in combinations.ResultsForty-nine patients, diagnosed between 1.1.2008 and 1.2.2018 were included; 27% also had multiple myeloma (MM). Revised Mayo score was ≥ 3 in 67%. Hematologic overall response rate was 81%, 64% achieved very good partial response (VGPR) or better. Concurrent active MM was associated with lower rates of VGPR (OR 0.19, 95% CI 0.04-0.81; P = .03) in a multi-variate analysis. Cardiac and renal responses were 74% and 73%, respectively. Median progression-free survival (PFS) was 28.4 months and median overall survival (OS) was not reached; 2-year PFS and OS were 68.6 ± 7.5% and 90.4 ± 4.6%, respectively. Hematologic response correlated with prolonged PFS and OS. Daratumumab was safe and well tolerated, no patients discontinued therapy due to toxicity. Our data was aligned with outcomes from a systematic literature review, which identified 10 case series (n = 517) and 2 clinical trials (n = 62) meeting prespecified criteria.ConclusionsOur data support favorable safety tolerability and efficacy of daratumumab among non-selective RRAL patients in a real-world setting.© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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