Phase 1 Myeloma Trial, Recruiting

Written by an AI model from the 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 that has been confirmed by laboratory testing, and whose myeloma has come back or stopped responding after at least 3 different lines of treatment — including one from each of these three types: an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
• People whose myeloma has not spread to the brain or spinal cord.
• People aged 18 or older.
• People who are reasonably well and able to carry out daily activities, based on a standard medical scoring system (ECOG score of 0, 1, or 2).
• People whose myeloma can be measured through at least one of several specific blood, urine, or bone marrow tests at the time of joining the trial (confirm with trial site for exact thresholds).
• People who have had at least 2 weeks pass since their last radiation or systemic treatment before the blood cell collection procedure.
• People whose liver function blood tests are within acceptable ranges (confirm with trial site).
• People whose kidney function blood test result is below a specific level (confirm with trial site).
• People whose heart is pumping adequately (ejection fraction above 45%) with no fluid around the heart, confirmed by a heart ultrasound.
• People whose lungs are working well enough, shown by an oxygen level of 92% or higher while breathing normal room air.
• People who are able to understand and willing to sign a consent form (or have a legal guardian who can do so).
• Women who could become pregnant must agree to avoid pregnancy by either abstaining from heterosexual intercourse or using a highly effective contraceptive method during treatment and for at least 90 days after receiving the trial treatment.
• Men must agree to either abstain from heterosexual intercourse or use contraception during the trial, and must agree not to donate sperm.

Who may not be able to join:

• People who have had an autologous stem cell transplant (using their own stem cells) within 6 weeks of signing the consent form.
• People who have previously had a stem cell transplant using donor cells.
• People who currently have graft-versus-host disease (a complication that can follow a donor stem cell transplant).
• People whose myeloma is currently active in the brain or spinal fluid, or who have untreated brain involvement; people with a past history of this may still be excluded unless they have been in confirmed remission for at least 90 days, shown by spinal fluid testing and MRI scan.
• People who currently have another active cancer, other than certain minor skin cancers or very early-stage cancers that have not spread.
• People who received another experimental treatment less than 28 days before the scheduled blood cell collection.
• People with a severe form of heart failure classified as New York Heart Association Class IV.
• People who have had serious heart or blood vessel problems — such as unstable chest pain, a heart attack, stroke, or significant irregular heartbeat — within the 6 months before joining.
• People who currently have an active infection that requires treatment through an intravenous drip.
• People who are HIV positive.
• Women who are pregnant or breastfeeding, as the trial treatment may carry risks to an unborn baby or infant; women who could become pregnant must have a negative pregnancy blood test before joining.
• People who have shown signs of a bone marrow condition called myelodysplasia, or have related abnormal chromosomal findings on a bone marrow test.
• People with an active hepatitis B or C infection; people who test positive for certain hepatitis markers must have a negative PCR test before joining, and those with a positive PCR result will not be eligible.
• People with a significant history of brain or neurological conditions such as epilepsy, seizure disorders, paralysis, severe stroke-related disease, serious brain injury, dementia, or Parkinson's disease.
• People with other serious ongoing or uncontrolled illnesses — including active infections, uncontrolled heart failure, irregular heartbeat, lung problems, or significant mental health or social circumstances that could affect participation in the trial.
• People who have another known cancer that currently requires systemic treatment.
• People with a history of an autoimmune disease (such as rheumatoid arthritis or lupus) who have needed immune-suppressing medications — other than low-dose steroids — within the past 6 months.

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