Actively Recruiting
Optimal Infection Prophylaxis Strategy for Relapsed/Refractory Multiple Myeloma Patients Undergoing Elranatamab Therapy
Led by Seoul National University Hospital · Updated on 2025-12-03
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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 informed consent.
- Confirmed seropositivity for CMV (CMV IgG positive).
- Diagnosis of multiple myeloma with measurable disease as defined by specific protein measurements or light chain levels.
- Patients with measurable extramedullary lesions if only extramedullary disease is present.
- Received at least three prior lines of antimyeloma therapy.
- Prior treatment with at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody.
- Documented disease progression during or after the last antimyeloma treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Agreement to pregnancy testing and contraceptive measures if of childbearing potential.
- Willingness and ability to follow study visits and protocol requirements.
- Agreement to avoid live vaccines during the study and specified periods after treatment.
- Agreement to refrain from donating sperm or eggs during and after the study as specified.
You will not qualify if you...
- History of CMV end-organ disease within 6 months before enrollment.
- Evidence of CMV viremia at screening.
- Recent or planned use of certain antiviral medications at specified doses within 7 days before screening or during the study.
- Known hypersensitivity to letermovir ingredients.
- Recent plasmapheresis or major surgery within 28 days before starting treatment.
- Prior allogeneic stem cell transplant within one year or recent autologous stem cell transplant within 12 weeks before treatment.
- Presence of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or significant light-chain amyloidosis.
- Known central nervous system involvement with myeloma.
- Any significant medical condition or uncontrolled infection that increases risk for treatment complications.
- Recent COVID-19 infection within 7 to 14 days depending on severity.
- Conditions that interfere with study data interpretation.
- Certain laboratory abnormalities including low neutrophil or platelet counts, poor kidney or liver function.
- Gastrointestinal conditions or surgeries affecting drug absorption.
- History of other malignancies unless disease-free for at least 3 years, with some exceptions.
- Recent immunosuppressive medication use except for specified low-dose steroids and topical treatments.
- Significant cardiovascular diseases within 6 months before enrollment.
- Uncontrolled hypertension or diabetes within 14 days before enrollment.
- Recent live vaccine within 3 months before starting study therapy.
- Positive for HIV, chronic or active hepatitis B or C infection.
- Ongoing severe neuropathy or history of Guillain-Barre syndrome.
- Pregnancy, nursing, breastfeeding, or intention to become pregnant during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks (6 cycles of 28 days each)
Participants receive Elranatamab therapy with a step-up dosing regimen and take Letermovir to prevent CMV infection.
Weekly or biweekly visits depending on dosing schedule
Duration - Up to 1 year
Participants are monitored for safety, tolerability, and incidence of CMV infection and disease after treatment completion.
Visits as scheduled for safety monitoring and assessments
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Ja Min Byun, MD, PhD
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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