Future oncology (London, England) · 2023
Daratumumab in Indian patients with relapsed and refractory multiple myeloma: a prospective, multicenter, phase IV study.
Клиническое исследование IV фазыМногоцентровое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Kumar Lalit, Melinkeri Sameer, Ganesan Prasanth, Kumar Jeevan, Biswas Ghanashyam, Kilara Nalini, Pathalingappa Harish, Prasad Svss, Jain Minish, Mishra Sourav Kumar, Prasad Saurabh, Boyella Pavan Kumar, Sahoo Ranjit Kumar, Bondarde Shailesh, Shah Sandip, Rege Milind, Deb Uttiya, Korde Tanuja, Dixit Jitendra
Аннотация
Aim: To assess the safety and effectiveness of daratumumab monotherapy in Indian patients with relapsed/refractory multiple myeloma. Methods: In this prospective, multicenter, phase IV study, patients (aged ≥18 years) received intravenous daratumumab (16 mg/kg) in six cycles. Safety was the primary end point. Results: Of the 139 patients included, 121 (87.1%) experienced ≥1 treatment-emergent adverse events (TEAEs; 53 [38.1%] drug-related), 32 (23%) had ≥1 serious TEAEs (five [3.6%] drug-related) and 16 (11.5%) deaths were reported (one death [0.7%] was drug-related). Overall response rate was 26.3%; 62.7% of patients had stable disease. Median time to first response and median progression-free survival were 5.2 and 5.9 months, respectively. Functional status and well-being were improved. Conclusion: Daratumumab showed an acceptable and expected safety profile with consistent efficacy, providing a novel therapeutic option for relapsed/refractory multiple myeloma management in India.