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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Letermovir
DrugElranatamab: 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).
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects with clinically significant CMV infection during 6 cycles of elranatamab treatment
Clinically significant CMV infection is defined as the occurrence of either one of the following outcomes: 1. onset of CMV end-organ disease or 2. initiation of anti-CMV pre-emptive therapy based on documented CMV viremia\* and the clinical condition of the subject. Initiation of pre-emptive therapy refers to the practice of initiating therapy with the following approved anti-CMV agents when active CMV viral replication is documented: ganciclovir, valganciclovir, foscarnet, and/or cidofovir. * Viral load threshold for initiating pre-emptive therapy is viral DNA ≥ 500 IU/mL in 2 consecutive assessments separated by at least 1 day, or, single viral DNA ≥ 1,000 IU/mL
Time frame
From Cycle 1 Day 1 to completion of Cycle 6 (Week 24; each cycle is 28 days)Secondary outcomes
1
Proportion of subjects with clinically significant CMV infection during 12 cycles of elranatamab treatment
Clinically significant CMV infection is defined as the occurrence of either one of the following outcomes: 1. onset of CMV end-organ disease or 2. initiation of anti-CMV pre-emptive therapy based on documented CMV viremia\* and the clinical condition of the subject. Initiation of pre-emptive therapy refers to the practice of initiating therapy with the following approved anti-CMV agents when active CMV viral replication is documented: ganciclovir, valganciclovir, foscarnet, and/or cidofovir. * Viral load threshold for initiating pre-emptive therapy is viral DNA ≥ 500 IU/mL in 2 consecutive assessments separated by at least 1 day, or, single viral DNA ≥ 1,000 IU/mL
Time frame
From Cycle 1 Day 1 to completion of Cycle 12 (each cycle is 28 days)2
Incidence of CMV disease during the first 6 and 12 cycles of elranatamab
Time frame
From Cycle 1 Day 1 to completion of Cycle 6 and Cycle 12, respectively (each cycle is 28 days)..3
Incidence of CMV viremia during the first 6 and 12 cycles of elranatamab
Virus detection of any titer. CMV viremia refers to CMV DNA levels in the plasma (=CMV DNAemia).
Time frame
From Cycle 1 Day 1 to completion of Cycle 6 and Cycle 12, respectively (each cycle is 28 days).4
Toxicity
Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.
Time frame
From Cycle 1 Day 1 to study completion, an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov