Optimal infection prophylaxis strategy for relapsed/refractory multiple myeloma patients undergoing elranatamab therapy (OPTIMUS-EL) (ASH 2025) - Dec 5, 2025 - P2 | "To close the gaps of current guidelines on infection risk mitigation and subsequently BsAb treatment optimization, we aim to investigate the efficacy and safety of letermovir for the prevention of clinically significant CMV infection in patients undergoing elranatamab therapy. Based on one-sample multiple testing procedure for phase II clinical trial (one-sided α error rate 5%, power 90%, p0 39.4 versus p1 17.5), the optimal sample size is 35. Considering the drop-off rate of 10%, 40 patients will be enrolled"
Clinical • Bone Marrow Transplantation • CNS Disorders • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Ocular Inflammation • Ophthalmology • Pneumonia • Respiratory Diseases • Retinal Disorders
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Ja Min Byun 1; Dong Hyun Kim 1; Youngil Koh 1; Chang-Ki Min 2; Kihyun Kim 3; Hee Jeong Cho 4; Ji Yun Lee 5
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