RecruitingPhase 2NCT06920251

Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy

Optimal Infection Prophylaxis Strategy for Relapsed/Refractory Multiple Myeloma Patients Undergoing Elranatamab Therapy

Sponsor

Seoul National University Hospital

Enrollment

40 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsed Refractory Multiple Myeloma (RRMM)

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether letermovir — a drug that prevents cytomegalovirus (CMV) infections — can safely protect multiple myeloma patients receiving a newer immunotherapy called elranatamab (a bispecific antibody). CMV reactivation is a known risk with this type of treatment. **You may be eligible if...** - You are 19 or older - You have multiple myeloma that has relapsed or no longer responds to treatment - You have previously tested positive for CMV (a common virus most people carry) - You have measurable myeloma confirmed by blood or urine tests - You are receiving or plan to receive elranatamab therapy **You may NOT be eligible if...** - You have never been exposed to CMV - You have serious kidney or liver problems that prevent taking letermovir - You are allergic to the study drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLetermovir

Elranatamab: Participants will receive SC administration of elranatamab QW, Q2W or Q4W. The initial doses of elranatamab will be 12 mg (C1D1) and 32 mg (C1D4) and will serve as the 2 step-up priming regimen. Dexamethasone: Dexamethasone is administered at the dose of 20 mg/day on C1D1, C1D4 and C1D8 as a premedication for elranatamab Letermovir: Letermovir is administered at the dose of 480mg/day PO from C1D15 (W3) to C4 (W16) (total of 98 days).