Phase 2 Study of Letermovir to Prevent CMV Infection in Adults with Relapsed or Refractory Multiple Myeloma Receiving Elranatamab Therapy

What this Trial Is About

Researchers are evaluating the use of letermovir to prevent significant cytomegalovirus CMV infections in adults with relapsed or refractory multiple myeloma MM who are CMV-seropositive and receiving treatment with Elranatamab, a bispecific antibody BsAb. The study is an open-label, single-arm, multicenter trial focused on this specific patient group to improve infection control during BsAb therapy, which is important for maintaining quality of life and treatment response. Participants will receive letermovir starting on day 15 of cycle 1 through cycle 4 a total of 98 days alongside Elranatamab treatment. Elranatamab is given subcutaneously weekly or less often according to dosing schedules, with initial step-up doses at the beginning of treatment. Dexamethasone is also given as a premedication to help manage side effects. The study monitors the effects of letermovir in reducing CMV infection during these treatment cycles. During the study, participants will be closely monitored for CMV infection through laboratory tests and clinical evaluations over at least 6 treatment cycles, extending to 12 cycles for secondary outcomes. Researchers will assess CMV infection rates, CMV disease, and CMV viral levels, as well as toxicity and tolerability over about one year. Participants must attend regular visits for assessments, including blood tests and safety monitoring, to ensure accurate data collection and participant safety throughout the trial.

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