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Subcutaneous daratu...
Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study
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Iida, S (author)
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Ishikawa, T (author)
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Min, CK (author)
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Kim, K (author)
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Yeh, SP (author)
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Usmani, SZ (author)
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Mateos, MV (author)
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- Nahi, H (author)
- Karolinska Institutet
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Heuck, C (author)
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Qin, X (author)
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Parasrampuria, DA (author)
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Gries, KS (author)
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Qi, M (author)
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Bahlis, N (author)
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Ito, S (author)
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(creator_code:org_t)
- 2021-02-18
- 2021
- English.
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In: Annals of hematology. - : Springer Science and Business Media LLC. - 1432-0584 .- 0939-5555. ; 101100:24, s. 1065-1077
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http://kipublication...
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https://doi.org/10.1...
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Abstract
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- The phase 3 COLUMBA study demonstrated noninferiority of subcutaneous daratumumab (DARA SC) to intravenous daratumumab (DARA IV) in relapsed or refractory multiple myeloma. We present a subgroup analysis of Asian patients from COLUMBA. Eligible patients had ≥ 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or were double refractory. Co-primary endpoints were overall response rate (ORR) and maximum trough concentration (Ctrough). Secondary endpoints included rates of infusion-related reactions, progression-free survival, and patient-reported satisfaction with therapy. Sixty-seven Asian patients (DARA SC, n = 30; DARA IV, n = 37) were randomized, including 42 Japanese patients (DARA SC, n = 18; DARA IV, n = 24). Comparable ORRs for DARA SC versus DARA IV were seen in the Asian cohort (66.7% vs 43.2%) and Japanese-only cohort (61.1% vs 54.2%), including patients weighing ≤ 65 kg. Similarity of Ctrough was seen in both Asian and Japanese-only cohorts; the ratio of the geometric mean of the Ctrough concentrations for DARA SC/DARA IV was 143.96% (90% confidence interval (CI), 112.03–185.00%) and 148.02% (90% CI, 113.32–193.34%), respectively. The Asian cohort (both treatment groups) and Japanese-only cohort (DARA SC group) experienced higher rates of grade 3/4 cytopenias compared with the global COLUMBA population, occurring predominantly in patients of low bodyweight; no patients discontinued treatment due to cytopenias. The Cancer Therapy Satisfaction Questionnaire results generally favored DARA SC. In the Asian and Japanese-only cohorts, DARA SC was comparable to DARA IV. The efficacy, pharmacokinetic, safety, and satisfaction results were generally consistent with the global COLUMBA population regardless of patient bodyweight. ClinicalTrials.gov Identifier: NCT03277105
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- By the author/editor
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Iida, S
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Ishikawa, T
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Min, CK
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Kim, K
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Yeh, SP
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Usmani, SZ
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show more...
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Mateos, MV
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Nahi, H
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Heuck, C
-
Qin, X
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Parasrampuria, D ...
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Gries, KS
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Qi, M
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Bahlis, N
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Ito, S
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show less...
- Articles in the publication
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Annals of hemato ...
- By the university
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Karolinska Institutet