Actively Recruiting
Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy
Led by Seoul National University Hospital · Updated on 2025-12-03
40
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older at the time of consent
- Ability to understand and voluntarily sign informed consent
- Willingness and ability to follow study visit schedule and protocol requirements
- Documented seropositivity for CMV (CMV IgG)
- Confirmed diagnosis of multiple myeloma with measurable disease (defined by specific laboratory criteria)
- Measurable extramedullary lesion if only extramedullary disease is present, with PET-CT follow-up
- Received three or more prior lines of antimyeloma therapy
- Received at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody
- Documented disease progression during or after last antimyeloma therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Individuals of childbearing potential must have two negative pregnancy tests prior to treatment, agree to ongoing pregnancy testing, and commit to abstinence or effective contraception use
- Male subjects must agree to abstinence or condom use during sexual contact with pregnant or childbearing potential individuals and refrain from sperm donation during and after treatment
- Female subjects must refrain from egg donation during and after treatment
- Agreement to avoid live vaccines during treatment and for 90 days after last dose
You will not qualify if you...
- History of CMV end-organ disease within 6 months prior to enrollment
- Evidence of CMV viremia at screening
- Use or planned use of specific antiviral drugs within 7 days prior to screening or during study
- Known hypersensitivity to letermovir or its ingredients
- Plasmapheresis within 28 days before treatment or major surgery within 28 days before treatment
- Allogeneic stem cell transplant within 1 year or autologous transplant within 12 weeks before treatment, with active graft-versus-host disease or immunosuppressant use
- Presence of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or significant light-chain amyloidosis
- Central nervous system involvement with myeloma
- Significant medical conditions or uncontrolled infections posing risk
- Recent COVID-19 infection within specified timeframes
- Conditions interfering with study data interpretation
- Specific laboratory abnormalities (low neutrophil or platelet counts, low kidney function, elevated liver enzymes or bilirubin)
- Gastrointestinal disease or surgery affecting oral drug absorption
- Prior malignancies other than MM unless disease-free for 3 years, with exceptions
- Immunosuppressive medication use within 14 days before treatment with some exceptions
- Impaired cardiovascular function or significant cardiovascular diseases within 6 months prior
- Uncontrolled hypertension or diabetes within 14 days prior
- Live vaccine within 3 months before study therapy
- Positive for HIV, chronic or active hepatitis B or C
- Ongoing Grade 3 or higher neuropathy, history of Guillain-Barre syndrome or variants
- Pregnancy, nursing, breastfeeding, or intent to become pregnant during study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Ja Min Byun, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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