This is an open-label, single arm, multicenter study to evaluate the feasibility of maribavir treatment in multiple myeloma and lymphoma patients undergoing bispecific antibody treatment and experiencing treatment emergent CMV events
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.
ECOG performance status of 0, 1, or 2. ⑦ Individual of childbearing potential (IOCBP) must: A. Have two negative pregnancy tests before study treatment, and agree to ongoing testing.
Requires ganciclovir, valganciclovir, foscarnet, or cidofovir for non-CMV indications or requires co-administration with maribavir.
Known hypersensitivity to maribavir. ③ CMV disease involving the CNS (retinitis alone is allowed). ④ Received allogeneic SCT within 1 year or autologous SCT within 12 weeks prior to study treatment.
Males: CrCl = (140 - age) × weight (kg) / (72 × creatinine [mg/dL])
Females: Multiply above result by 0.85 B. AST or ALT >5 × ULN C. Total bilirubin >3 × ULN (except Gilbert's syndrome)
Single group
Maribavir
DrugParticipants will receive maribavir 400 mg twice daily starting from Week 1 and continuing until clearance of CMV. CMV clearance is defined as either an unquantifiable plasma CMV DNA titer (i.e., below the lower limit of quantification \[LLOQ\]) as assessed by the local laboratory, or a CMV DNA level below 500 IU/mL in plasma without evidence of CMV disease.
Rate to Achieve CMV DNA Titer Reduction to < 500 IU/mL
The proportion (%) of patients whose plasma CMV DNA titer decreases to below 500 IU/mL at any point during maribavir treatment, as assessed by local laboratory testing.
Time to Achieve CMV DNA Titer Reduction to < 500 IU/mL
The time (in days) from the initiation of maribavir treatment to the first documented plasma CMV DNA titer of \< 500 IU/mL, confirmed by local laboratory testing.
Safety outcomes
Adverse events (AEs) will be evaluated in terms of type, frequency, seriousness, and severity, and their relationship to maribavir will be assessed. All AEs will be graded according to the NCI CTCAE criteria, and their causality with study drug will be determined by the investigator.
Rate to Achieve ≥1 log₁₀ Decrease in CMV DNA Titer From Baseline
The proportion (%) of patients who achieve a reduction of ≥1 log₁₀ in plasma CMV DNA titer from baseline (i.e., the time of maribavir initiation), as assessed by local laboratory testing.
Time to Achieve ≥1 log₁₀ Reduction in Plasma CMV DNA Titer From Baseline
The time (in days) from maribavir initiation to the first documented ≥1 log₁₀ decrease in plasma CMV DNA titer from baseline, as assessed by local laboratory testing.
Rate of Breakthrough CMV Disease
The proportion (%) of patients who develop CMV disease during or after maribavir treatment, despite initial virologic control or response.
Immunity
Host immune status will be evaluated using CD4+/CD8+ T-cell counts, serum immunoglobulin levels (IgG, IgA, IgM), and CMV-specific cell-mediated immunity (CMI). CMV-CMI will be assessed at a central lab using the T-SPOT.CMV assay (Oxford Immunotec), which measures interferon-gamma-producing T cells in response to CMV antigens IE-1 and pp65.
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