Phase 2 Study of Maribavir for Treating Cytomegalovirus in Patients with Multiple Myeloma or Lymphoma Receiving Bispecific Antibody Therapy

What this Trial Is About

Researchers are evaluating the safety and feasibility of maribavir in patients with multiple myeloma or lymphoma who develop cytomegalovirus CMV reactivation during treatment with bispecific antibodies BsAbs. BsAbs are increasingly used due to their effectiveness but carry a high risk of infections like CMV, especially in patients who have had extensive prior treatments and weakened immune systems. Maribavir is an oral antiviral drug with a new mechanism and a favorable safety profile, offering a potential alternative to existing CMV treatments that may have limitations due to toxicity or accessibility. Participants will receive maribavir at a dose of 400 mg twice daily starting from Week 1 and continuing until CMV clearance. CMV clearance is defined as either an unquantifiable plasma CMV DNA level or a plasma CMV DNA level below 500 IUmL without evidence of CMV disease. This is a single-arm, open-label study involving patients diagnosed with multiple myeloma, follicular lymphoma, or large B-cell lymphomas who are receiving bispecific antibody therapy and have documented clinically significant CMV infection. During the study, participants will be monitored from screening until Week 18 for safety and CMV DNA titer reduction. Researchers will measure how quickly and effectively the CMV DNA level drops below 500 IUmL and track any safety outcomes during treatment. The study also evaluates the rate and timing of a significant reduction in CMV DNA and the occurrence of breakthrough CMV disease up to four weeks after starting maribavir. Total participation duration depends on individual CMV clearance time.

Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies