None listed
Conditions
Interventions
Drug, Biological/Vaccine, Stem Cell : The subject will receive elanatumab QW,Q2W, or Q4w by SC. The initial dose of elanatumumab will be 12 mg (C1D1) and 32 mg (C1D4), followed by 76 mg.
Letermovir wi
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Participants must be at least 19 years of age at the time of signing the informed consent form (ICF) and have an expected life expectancy of at least six months. ?Participants must understand the ICF and sign it voluntarily prior to the conduct of any research-related evaluations or procedures. ?Participants must be willing and able to comply with the research visit schedule and other protocol requirements. ?Participants must have a documented history of CMV seropositivity (CMV IgG seropositivity) at any point in time. CMV IgG status will be reconfirmed during the screening test. ? Plasma CMV DNA titer must not be detected during the screening test (< lower limit of quantification; LLOQ). ?The subject must have a documented diagnosis of MM and measurable disease defined as one of the following: A. Serum protein electrophoresis (sPEP) showing M-protein = 0.5 g/dL or B. Urinary protein electrophoresis (uPEP) showing M-protein = 200 mg/24 hours in a 24-hour urine collection or C. For study participants without measurable disease on sPEP or uPEP: serum free light chain (sFLC) concentration of the involved light chain exceeds 100 mg/L (10 mg/dL) and the kappa/lambda FLC ratio is abnormal. * Patients with measurable disease and extramedullary disease (EMD) are eligible for the trial if measurable lesions are present. In these patients, PET-CT follow-up is required for response evaluation. Patients with EMD alone are not eligible for the trial. ? Subjects who have previously received three or more lines of antimyeloma therapy. (Note: Multiple periods may be included in a single line [e.g., induction therapy, autologous hematopoietic stem cell transplantation (included or excluded), intensification therapy (included or excluded), and/or maintenance therapy]). ?The subject must have received at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 antibody. *Previous use of anti-BCMA antibody drug conjugates is permitted, but exposure to anti-BCMA bispecific antibodies is not permitted. **Exposure to non-BCMA bispecific antibodies is permitted. ?The subject must have documented disease progression during or after the last multiple myeloma treatment. ?The ECOG performance status score must be 0, 1, or 2. ?Women of childbearing potential (FCBP) must meet the following criteria: A. Two negative pregnancy tests performed prior to the start of the trial treatment must be verified by the investigator. Women of childbearing potential must agree to undergo pregnancy testing concurrent with the trial throughout the trial and after the completion of trial treatment. This applies even if the subject is practicing true abstinence* from sexual contact with males. B. Commit to true abstinence* from sexual contact with males (must be reviewed monthly and documented) or agree to and be able to comply with two forms of contraception as follows: One highly effective contraceptive method and another effective (barrier) contraceptive method for the 28 days prior to the start of the trial treatment, during the clinical trial treatment (including treatment discontinuation), and for the longer of the following periods: at least 90 days after the last dose of letermovir or 6 months after the last dose of elranatamab. Note: Women of childbearing potential (FCBP): This refers to individuals who: 1) Have ever had menarche (first menstrual period); 2) Individuals who have not undergone hysterectomy (surgical removal of the uterus), bilateral salpin
Exclusion criteria
Exclusion criteria: 1. Participants with a history of CMV disease within the past 6 months prior to registration. 2. Participants with evidence of CMV viremia at screening 3. Participants who have received or plan to receive any of the following within 7 days prior to testing or during the study period: A. Ganciclovir B. Valganciclovir C. Foscarnet D. Acyclovir, exceeding 3200 mg PO per day or exceeding 25 mg/kg per day by intravenous injection E. Valacyclovir, when taken at a dose exceeding 3000 mg PO per day F. Famciclovir, when taken at a dose exceeding 1500 mg PO per day 4. Individuals with suspected or known hypersensitivity to the active or inactive ingredients of letermovir. 5. Patients who have received any of the following: A. Plasma exchange performed within 28 days prior to the start of the trial treatment. B. Major surgery (as defined by the investigator) performed within 28 days of the start of the trial treatment. 6. Patients who have received allogeneic stem cell transplantation within the past year or autologous stem cell transplantation within 12 weeks prior to the first dose. Patients who have received allogeneic stem cell transplantation must have no evidence of active graft-versus-host disease (GVHD). *Ineligible if currently receiving immunosuppressive therapy. The subject has multiple myeloma, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant light chain amyloidosis. 7. Subjects with lymphocytic leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organ enlargement, endocrine disorders, monoclonal protein, skin changes, clinically significant light chain amyloidosis) 8. The trial subject has known central nervous system (CNS) involvement of multiple myeloma. 9. The trial subject has any significant medical condition, including active or uncontrolled infection, abnormal laboratory test results, or mental illness, that would place the trial subject at unacceptable risk of complications related to treatment if the trial subject participates in the trial. 10. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: For mild or asymptomatic infection prior to the start of the study treatment, a period of 7 days is required; for severe/critical illness, a longer period may be necessary at the investigator’s clinical judgment. i) Acute symptoms have resolved, and there is no high risk associated with study participation. No further monitoring or repeated testing for COVID-19 is required. 11. If the subject has a condition that could confuse the interpretation of study data. 12. If the subject has any of the following abnormal laboratory test results: A. Absolute neutrophil count (ANC) 2.5 times the upper limit of normal (ULN) E. Serum total bilirubin > 1.5 × ULN or Gilbert's syndrome with bilirubin = 3.0 mg/dL F. Corrected serum calcium >14 mg/dL (>3.5 mmol/L), or free ionized calcium >6.5 mg/dL (>1.6 mmol/L) 13. Subjects with gastrointestinal disease or surgery (e.g., gastric bypass surgery) that may significantly affect the absorption of letermovir and/or other oral investigational agents. 14. Subjects with a hist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with clinically significant CMV infection during the 6th cycle of Elranatamab treatment (up to W24) | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with clinically significant CMV infection during 12 cycles of elranatamab treatment. | — |
Countries
Korea, Republic of
Contacts
Public ContactJamin Byun
Seoul National University Hospital
Outcome results
None listed