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 have been diagnosed with multiple myeloma according to standard international diagnostic guidelines, with measurable signs of the disease detectable in blood or urine tests at the time of screening.
• People whose myeloma has either come back after a previous treatment worked for a time, or whose myeloma did not respond adequately to previous treatment (relapsed or refractory disease).
• People who have already received at least two prior treatment regimens for myeloma, including at least one proteasome inhibitor (a specific type of myeloma drug) and at least one immunomodulatory drug (another specific type of myeloma drug).
• People whose blood counts and organ function meet minimum levels during screening — including haemoglobin, platelets, white blood cells, liver enzymes, kidney function, bilirubin, and calcium (confirm specific values with the trial site).
• People living with HIV may be eligible if they have an undetectable viral load, a sufficiently healthy immune system (CD4+ count above 300 cells/mm³), no recent serious HIV-related infections, and are on stable HIV treatment.
• Male participants must agree to use a condom with spermicide during any activity that could pass ejaculate to another person, both during the study and for at least 100 days after the last dose of study treatment.
• Male participants must agree not to donate sperm during the study and for at least 100 days after the last dose of study treatment.
• People who are willing and able to follow all study rules, including not donating blood or blood products during the study and for 100 days after the last dose.
• People who are willing to sign a consent form showing they understand the study and agree to take part before any study-related tests or procedures begin.

Who may not be able to join:

• People who have a known serious allergy or dangerous reaction to any of the study drugs or their ingredients.
• People who have previously been treated with T-cell-engaging antibody therapies.
• People who have previously received any treatment that specifically targets the GPRC5D protein on myeloma cells.
• People who have received certain recent cancer treatments within specific time windows before the first study dose, including gene-modified cell therapies (within 3 months), targeted or investigational therapies (within 21 days or 5 half-lives), monoclonal antibody treatments for myeloma (within 21 days), chemotherapy (within 21 days), proteasome inhibitors (within 14 days), immunomodulatory agents (within 14 days), or radiotherapy (within 7–14 days, depending on type).
• People who still have significant side effects from previous cancer treatments that have not returned to near-normal levels (with the exception of hair loss or nerve-related symptoms in the hands and feet).
• People who have received high doses of corticosteroids (equivalent to 140 mg or more of prednisone) in the 14 days before the first study dose.
• People who have had an allogeneic (donor) stem cell transplant at any time, or an autologous (own cells) stem cell transplant within 12 weeks before the first study dose.
• People with known active involvement of myeloma in the brain or the fluid surrounding the brain and spinal cord.
• People with certain related but distinct blood or plasma cell conditions, including plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis.
• People with a bone marrow disorder called myelodysplastic syndrome, or with another active cancer that has been progressing or required treatment changes in the last 24 months (some specific exceptions apply — confirm with the trial site).
• People who have had a stroke or seizure within 6 months before signing the consent form.
• People with an active hepatitis B or hepatitis C infection (specific testing rules apply — confirm with the trial site).
• People with certain ongoing medical or psychiatric conditions that could interfere with the study, such as uncontrolled diabetes, active serious infections, active autoimmune disease requiring immune-suppressing treatment within the past 6 months, severe dementia, or disabling psychiatric conditions including alcohol or drug dependency (some exceptions apply — confirm with the trial site).
• People with a history of not following recommended medical treatments.
• Male participants who plan to father a child during the study or within 100 days after the last dose of study treatment.
• People with serious heart conditions, including advanced heart failure (New York Heart Association stage III or IV), a heart attack or heart bypass surgery within the past 6 months, uncontrolled irregular heart rhythms, a history of serious ventricular heart rhythm problems, unexplained loss of consciousness, or severe non-ischaemic cardiomyopathy.
• People who have had major surgery within 2 weeks before starting treatment, have not fully recovered from surgery, or have major surgery planned during the expected treatment period or within 2 weeks after the last dose (minor procedures under local anaesthetic may be acceptable — confirm with the trial site).
• People with chronic obstructive pulmonary disease (COPD) where lung function testing shows the lungs are working at less than 50% of expected capacity.
• People with moderate or persistent asthma that has been active in the past 2 years, or any asthma that is currently uncontrolled (people with well-controlled mild or intermittent asthma may still be eligible — confirm with the trial site).

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