Phase 1 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:

• You are 18 years of age or older
• You have been diagnosed with multiple myeloma that can be measured through specific blood, urine, or bone marrow tests
• You have received at least two previous rounds of cancer treatment
• You have previously been treated with three specific types of myeloma therapy: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody (such as daratumumab) — and your myeloma is no longer responding to daratumumab
• Your myeloma cells show a protein called CD38 on their surface, confirmed by a bone marrow sample test
• Your myeloma is either no longer responding to your most recent treatment, or you could not tolerate it
• You are generally well enough to carry out most daily activities (confirm with trial site)
• Your most recent cancer treatments were completed a certain number of days before joining, depending on the type of treatment (confirm with trial site for specific timeframes)
• Your blood counts, liver function, and kidney function are within acceptable ranges, based on recent blood tests
• If you are a woman who could become pregnant, you have a negative pregnancy test before starting the trial
• If you are a woman who could become pregnant, you agree to use highly effective birth control during the study and for 6 months after your last dose
• If you are a man who is sexually active with someone who could become pregnant, you agree to use barrier contraception during the study and for 6 months after your last dose, and agree not to donate sperm during this time
• You have signed a consent form agreeing to take part

Who may not be able to join:

• You received daratumumab or another anti-CD38 antibody treatment less than 3 months before enrolling
• You have previously received any radioactive drug therapy for cancer
• Your body has developed detectable antibodies against daratumumab
• You have previously had radiation to more than 25% of your bone marrow
• You are currently breastfeeding or have a positive pregnancy test at screening
• You have had major surgery within 14 days before starting the study
• You are currently receiving other chemotherapy, radiation, or biological cancer treatments, or are taking bone marrow stimulating drugs (with some exceptions — confirm with trial site)
• You have received a live vaccine within 4 weeks of starting the study drug
• You have been diagnosed with certain related blood or protein disorders, including primary amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome
• You have severe, poorly controlled asthma or severe chronic obstructive pulmonary disease (COPD) based on breathing tests (confirm with trial site)
• You have known serious allergies or intolerances to monoclonal antibodies or human proteins (note: people who had manageable infusion reactions to daratumumab in the past may still be eligible — confirm with trial site)
• You have uncontrolled HIV, active hepatitis A or C, or active or chronic hepatitis B (people with well-managed HIV may still be eligible — confirm with trial site)
• You have significant heart problems, such as severe heart failure, a heart attack within the past 12 months, or poorly controlled chest pain (angina)
• You have another active cancer at this time (some early-stage or easily managed skin and other cancers may be exceptions — confirm with trial site)
• You have any other health condition that the trial doctor believes would make participation unsafe
• You may not be able to follow all the study requirements for practical or personal reasons

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