Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy
Trial Parameters
Brief Summary
This is an open-label, single arm, multicenter study to evaluate the efficacy of letermovir in the prevention of clinically significant CMV infection in adult, CMV-seropositive relapsed/refractory MM patients undergoing BsAbs therapy.
Eligibility Criteria
Inclusion Criteria: * Subjects must satisfy the following criteria to be enrolled in the study: * Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF). * Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. * Subject is willing and able to adhere to the study visit schedule and other protocol requirements. ④ Subjects have documented seropositivity for CMV (CMV IgG seropositvity) at any point. CMV IgG status will be re-checked during screening. ⑤ Subject has documented diagnosis of MM and measurable disease, defined as any of the following: A. M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or B. M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or C. For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio. \*Patients with ext