Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
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
Qualifiers
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.
Subject must have documented disease progression during or after their last antimyeloma regimen.
Disqualifiers
Subject who has a history of CMV end-oragn disease within 6 months prior to enrollment.
Subject who has evidence of CMV viremia at screening (D-7 CMV DNA results required - for specifics refer to section 5.3 and schedule of activities; SoA).
Subject who has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.
Subject has received any of the following. A. Plasmapheresis within the last 28 days of initiating study treatment B. Major surgery (as defined by the investigator) within 28 days of initiating study treatment.
Trial design
Treatments tested in this trial
- Letermovir
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov