ArticleScientific reports2024
Phase 1 study of isatuximab monotherapy in Chinese patients with relapsed/refractory multiple myeloma.
Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03733717 (An Open-label, Multi-center Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma), which is not on this map. Not yet cited in PubMed.
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An Open-label, Multi-center Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
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11 authors.
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Abstract
In this multi-center, Phase-1 study (NCT03733717), we characterized the pharmacokinetics (PK) of the anti-CD38 antibody isatuximab (Isa) after IV administration (primary objective), and evaluated safety, immunogenicity, and preliminary anti-myeloma activity in Chinese patients with relapsed/refractory multiple myeloma (RRMM). Isa 20-mg/kg was administered weekly (QW) in cycle 1, then biweekly (Q2W). Twenty-one extensively pretreated RRMM patients (median 4 prior lines; 95.2% refractory to last regimen), received ≥ 1 dose of Isa. After first IV-infusion, mean maximum observed concentration was 402 μg/mL and mean area-under-the-concentration-versus-time curve (first 1-week dosing interval) 37,000 μg·h/mL. After repeated administration, exposure (C
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