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:

• Adults aged 18 or older
• People who have previously been diagnosed with multiple myeloma and whose disease has come back or stopped responding to treatment
• For the first phase of the trial (dose escalation): people who have already received at least 3 prior rounds of treatment, including specific drug types — a proteasome inhibitor, an immunomodulatory drug, and a CD38 antibody (each for at least 2 cycles or 2 months) — prior treatment targeting a protein called BCMA is also allowed
• For the expansion phase of the trial: people who have received at least 2 prior rounds of treatment, including the same three drug types listed above, and whose disease is no longer responding to a drug called lenalidomide
• People whose disease can be measured through specific blood, urine, or protein tests that meet the levels set by the trial
• People who are generally well enough to carry out daily activities with no or only minor limitations (as measured by a standard medical scale)
• People whose kidneys, liver, and blood cell counts are functioning at levels that meet the trial's minimum requirements
• Women who could become pregnant must have two negative pregnancy tests before starting treatment, taken at specific times beforehand
• People who agree to use two reliable forms of contraception during the trial and for a set period after treatment ends, and to not donate eggs or sperm during that time
• People who are up to date on recommended vaccinations before starting treatment
• People who are willing and able to attend all required visits and follow the study schedule, including long-term follow-up
• People who have given signed consent before any trial procedures begin

Who may not be able to join:

• People who still have significant ongoing side effects (grade 2 or higher) from previous cancer treatments
• People with moderate or severe nerve damage in their hands or feet, or nerve pain of a certain severity
• People who have recently received certain cancer treatments within specific timeframes — for example, chemotherapy within 3 weeks, immunomodulatory or proteasome inhibitor drugs within 2 weeks, monoclonal antibodies within 4 weeks, CAR-T cell therapy or stem cell transplant within 3 months, or other newer therapies within a defined washout period
• People who have had radiation therapy within 14 days before starting the trial (with a limited exception for very low bone marrow exposure)
• People who have previously received treatment targeting a protein called GPRC5D, or who have previously been treated with the specific drug being studied in this trial (Iber)
• People with an active, uncontrolled infection of any kind (viral, bacterial, or fungal), or who have HIV, active hepatitis B, or active hepatitis C — some exceptions may apply for certain hepatitis B situations (confirm with trial site)
• People with another active cancer that could affect how results are measured — some exceptions apply for certain low-risk or previously treated cancers (confirm with trial site)
• People who are pregnant or breastfeeding
• People with significant heart problems, including severe heart failure, uncontrolled high blood pressure, irregular heart rhythm not managed by medication, or a history of heart attack or stroke within the past 6 months
• People with certain other serious blood or nerve-related conditions such as POEMS syndrome, AL amyloidosis, plasma cell leukaemia, or myeloma affecting the brain or nervous system
• People with serious uncontrolled problems with major organs that could increase risk from the treatment
• People who have had major surgery within the past 4 weeks, or a digestive condition that would prevent oral medications from being properly absorbed
• People who require high-dose steroids or other immune-suppressing medications for an ongoing condition, taken within 14 days before starting the trial — low-dose or inhaled steroids may be permitted in some cases (confirm with trial site)
• People who received a donor stem cell transplant within the past 6 months, or who still need immune-suppressing medication or have active graft-versus-host disease from a past transplant
• People with uncontrolled epilepsy or a seizure within the past 6 months
• People who received a live vaccine within 4 weeks before starting the trial

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