NCT06920251

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

Optimal Infection Prophylaxis Strategy for Relapsed/Refractory Multiple Myeloma Patients Undergoing Elranatamab Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, single arm, multicenter study to evaluate the efficacy of letermovir in the prevention of clinically significant cytomegalovirus (CMV) infection in adult, CMV-seropositive relapsed/refractory multiple myeloma (MM) patients undergoing Elranatamab therapy. Elranatamab is bispecific antibody (BsAb), and as BsAbs prolong survivals of MM patients, supportive care is becoming increasingly important to ensure good quality of life and sustain treatment response. Infection control constitutes a major pillar of such supportive care. BsAbs are already very expensive, thus dealing with complications secondary to desultory use will ultimately tantamount to significant financial burden in any given healthcare system. Therefore, implementing risk adaptive prophylactic measures and establishing active monitoring know-hows is important.

Conditions

• Relapsed Refractory Multiple Myeloma (RRMM)

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-09-11
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-04-09
• Last updated: 2025-12-03

Locations

1 site across 1 country: South Korea