Phase 2 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 19 years of age or older at the time of signing the consent form.
• People who are willing and able to understand and sign a consent form before any study procedures begin.
• People who are able to attend scheduled study visits and follow the study requirements.
• People who have previously tested positive for a virus called CMV (cytomegalovirus) through a blood antibody test, at any point in the past — this will be re-checked during the screening process.
• People who have a confirmed diagnosis of multiple myeloma (MM) with measurable disease, meaning the disease can be detected through specific blood, urine, or protein tests.
• People who have already received 3 or more separate rounds (lines) of treatment for their multiple myeloma.
• People whose prior myeloma treatment included at least one medicine from each of these three groups: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody (confirm with trial site if unsure which medicines these include).
• People whose myeloma has come back or gotten worse during or after their most recent myeloma treatment.
• People who have a general health/activity level rated as 0, 1, or 2 on a standard medical scale (meaning they are fully active to somewhat limited in strenuous activity but still able to care for themselves).
• People who are able to have children and who agree to use two forms of contraception — one highly effective and one barrier method — for the required time periods, and who agree to regular pregnancy testing throughout the study.
• People who are able to have children and who, if choosing abstinence instead of contraception, agree to review this monthly and have it documented.
• Male participants who agree to use a condom during sexual contact with someone who is pregnant or could become pregnant, throughout the study and for at least 90 days after the last dose of one of the study drugs (letermovir), even after a vasectomy.
• Male participants who agree not to donate sperm during the study and for at least 90 days after the last dose of letermovir.
• Female participants who agree not to donate eggs during the study and for at least 90 days after the last dose of letermovir.
• People who agree not to receive any live vaccines during the study and for at least 90 days after the last dose of one of the study drugs (elranatamab).

Who may not be able to join:

• People who have had serious organ damage caused by CMV within the 6 months before enrolling.
• People who have active CMV virus detected in their blood at the time of screening.
• People who have taken, or plan to take during the study, certain antiviral medicines (including ganciclovir, valganciclovir, foscarnet, or high doses of acyclovir, valacyclovir, or famciclovir) within 7 days before screening.
• People who have a known allergy or sensitivity to letermovir or any of its ingredients.
• People who have had a plasma exchange (plasmapheresis) procedure within the 28 days before starting study treatment.
• People who have had major surgery within 28 days before starting study treatment.
• People who have had a donor stem cell transplant (allogeneic) within the past year, or an autologous (own cells) stem cell transplant within 12 weeks of starting study treatment — and those who had a donor transplant must show no signs of graft-versus-host disease and must be off immunosuppressant medicines.
• People who have plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or clinically significant light-chain amyloidosis (these are specific blood or protein-related conditions — confirm with trial site if unsure).
• People whose multiple myeloma has spread to the brain or spinal cord (central nervous system).
• People who have a significant medical condition, active or uncontrolled infection, concerning lab results, or a mental health condition that would make participation too risky.
• People who have had COVID-19 within 7 days (for mild or no symptoms) or 14 days (for moderate or severe illness) before starting treatment — or longer if the treating doctor determines it is needed.
• People who have a condition that would make it difficult to understand or interpret their results in the study.
• People whose blood test results show any of the following: very low white blood cell count (neutrophils below 1,000/µL), very low platelet count (below 25,000/µL), poor kidney function (eGFR below 30 or on dialysis), or liver enzyme or bilirubin levels above certain thresholds.
• People who have a gut condition or have had gut surgery (such as gastric bypass) that could affect how the body absorbs the study medicines.
• People who have had another cancer in the past, unless they have been cancer-free for 3 or more years — with some exceptions for certain treated skin cancers or a specific type of in-situ cancer treated with curative intent (confirm with trial site).
• People who have taken immune-suppressing medicines within 14 days before starting study treatment, with some exceptions for low-dose steroids or local steroid treatments.
• People who have had certain significant heart or blood vessel problems within the 6 months before enrolling, including heart attack, unstable chest pain, serious heart rhythm problems, blood clots, stroke, or signs of reduced heart function.
• People who have uncontrolled high blood pressure or uncontrolled diabetes within 14 days before enrolling.
• People who have received a live vaccine within 3 months before starting study treatment.
• People who are HIV-positive, or who have active or chronic hepatitis B or C, or active hepatitis A (with some specific exceptions based on hepatitis B test results — confirm with trial site).
• People who have significant ongoing nerve damage (grade 3 or higher), a history of Guillain-Barré syndrome, or a history of serious nerve-related muscle problems.
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study.

Important: Always verify eligibility with the trial site directly before applying.