Please use this identifier to cite or link to this item: https://hdl.handle.net/11499/37063
Title: Early access program results from Turkey and a literature review on daratumumab monotherapy among heavily pretreated patients with relapsed/refractory myeloma
Authors: Beksac, M.
Aydin, Y.
Goker, H.
Turgut, Mehmet
Besisik, S.K.
Cagirgan, S.
Tuglular, T.
Keywords: EAP
Efficacy
RRMM
Safety
Survival
bortezomib
daratumumab
lenalidomide
melphalan
pomalidomide
prednisolone
thalidomide
adult
aged
anemia
Article
cancer diagnosis
cancer fatigue
cancer recurrence
clinical article
cohort analysis
controlled study
coughing
drug approval
drug efficacy
drug safety
drug tolerability
drug withdrawal
dyspnea
female
fever
human
lower respiratory tract infection
male
middle aged
monotherapy
multiple cycle treatment
multiple myeloma
nausea
neuropathy
neutropenia
overall survival
pneumonia
progression free survival
prospective study
rash
throat irritation
thrombocytopenia
treatment duration
treatment response
upper respiratory tract infection
Publisher: Elsevier Inc.
Abstract: Background: In countries where frontline drug approval is limited to first-generation proteasome inhibitors or immunomodulatory drugs, relapses have been both more frequent and less durable. We investigated real world data on the efficacy and safety of daratumumab monotherapy among patients with relapsed refractory multiple myeloma (RRMM) from Turkey using a prospective early access program. Patients and Methods: A total of 42 patients with RRMM after a minimum of 3 previous lines of proteasome inhibitor/immunomodulatory drug-based treatments were included from 25 centers across Turkey. Daratumumab monotherapy was administered intravenously at a dose of 16 mg/kg weekly (cycles 1-2), on alternate weeks (cycles 3-6), and monthly thereafter. Results: The median daratumumab monotherapy duration was 5.5 months (range, 0.2-28.7 months). The overall response rate was 45.2%, including 14 (33.3%) partial responses, 4 (9.5%) very good partial responses, and 1 (2.4%) complete response. The median duration of response was 4.9 months. The median progression-free survival (PFS) was 5.5 (95% confidence interval, 2.6-8.4 months) with 12- and 18-month PFS rates of 35.7% and 31.0%, respectively. The median overall survival was not reached; the 12- and 18-month overall survival rates were 64.3% and 59.5%, respectively. The depth of response had a significant effect on PFS (log-rank test, P = .026). Overall, of the 76 adverse events reported, 33 (43.4%) were grade ? 3; only 4 (9.52%) were grade 3 infusion-related reactions. No infusion-related reactions or adverse events led to treatment discontinuation. Conclusion: The present findings from our daratumumab early access program have confirmed the efficacy and safety profile of daratumumab monotherapy in heavily pretreated Turkish patients with RRMM. The present study investigated the efficacy and safety profile of daratumumab monotherapy in 42 patients with relapsed refractory multiple myeloma through a Turkish early access program. The current findings have confirmed the efficacy of daratumumab monotherapy in heavily pretreated patients with refractory multiple myeloma because of the deep and durable responses and favorable safety and tolerability profile. © 2020 The Authors
URI: https://hdl.handle.net/11499/37063
https://doi.org/10.1016/j.clml.2020.02.017
ISSN: 2152-2650
Appears in Collections:PubMed İndeksli Yayınlar Koleksiyonu / PubMed Indexed Publications Collection
Scopus İndeksli Yayınlar Koleksiyonu / Scopus Indexed Publications Collection
Tıp Fakültesi Koleksiyonu
WoS İndeksli Yayınlar Koleksiyonu / WoS Indexed Publications Collection

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