Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 1:19 PM
Study NCT ID:
NCT06920251
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Optimal Infection Prophylaxis Strategy for Relapsed/Refractory Multiple Myeloma Patients Undergoing Elranatamab Therapy
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMUS-EL
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: