Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy

NCT06920251 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-03

No results posted yet for this study

Summary

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

  • Relapsed Refractory Multiple Myeloma (RRMM)

Interventions

DRUG

Letermovir

Elranatamab: 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).

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06920251 on ClinicalTrials.gov