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 willing to give written consent to take part and understand they are free to withdraw at any time without affecting their future care.
• People aged 18 years or older, of any gender.
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
• People who have already been diagnosed with multiple myeloma according to standard international diagnostic guidelines.
• People whose multiple myeloma is measurable through blood or urine tests before receiving the study treatment — for example, a certain level of abnormal protein detected in the blood or urine, or an abnormal balance of light chain proteins in the blood.
• People who have already received idecabtagene vicleucel (a type of cell therapy) as a standard treatment, responded to it with at least a partial response, and whose myeloma has since relapsed — and who previously received at least four prior lines of treatment including specific types of standard myeloma drugs (an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody).
• People whose heart is pumping at least 40% of its capacity, as measured by a heart scan.
• People whose blood counts and organ function meet the following minimum levels before starting the study (with some flexibility allowed if supported by transfusions or medications completed at least 7 days before treatment begins):
  • Neutrophil count (infection-fighting white blood cells) of at least 1,000 per microlitre.
  • Platelet count of at least 25,000 per microlitre.
  • Haemoglobin (a measure of red blood cells) of at least 8 g/dL.
  • Kidney function producing a creatinine clearance of at least 30 mL/min.
  • Liver function within acceptable ranges, including bilirubin below 2 mg/dL and liver enzyme levels below 2.5 times the upper limit of normal (people with a condition called Gilbert's syndrome may still be considered with approval from the lead investigator).
• Women who could become pregnant, and men, must agree to use reliable contraception during the study and for a set period after treatment ends, due to unknown risks to an unborn baby — and must notify the treating doctor immediately if pregnancy occurs or is suspected.

Who may not be able to join:

• People with certain related blood or plasma conditions, including smouldering myeloma, plasma cell leukaemia, POEMS syndrome, or amyloidosis.
• People who have had a stem cell transplant within the 12 weeks before enrolling, or who have active graft-versus-host disease.
• People with active infections including hepatitis B, hepatitis C, HIV, COVID-19 (SARS-CoV-2), or any uncontrolled bacterial, fungal, or viral infection that has not resolved at least 14 days before enrolment.
• People who have had certain significant heart or blood vessel problems within the 6 months before enrolment, such as a heart attack, unstable chest pain, uncontrolled irregular heart rhythms, blood clots, stroke, or a specific heart electrical abnormality (prolonged QT interval).
• People who have had another active cancer within the past 3 years, except for certain treated skin cancers or non-invasive (in situ) cancers.
• People with ongoing nerve damage (neuropathy) in their hands or feet rated as grade 2 or above.
• People with a history of Guillain-Barré syndrome or related nerve conditions, or a history of severe (grade 3 or higher) motor nerve damage.
• People who have previously been treated with an anti-BCMA bispecific antibody (the same type of drug being studied in this trial).
• Women who are pregnant or breastfeeding, as the study drug may be harmful to an unborn baby or infant.
• People with a known or suspected allergic reaction to the study drug or any of its ingredients.
• People currently taking part in another clinical trial using an investigational treatment for this condition.
• People who have received a live vaccine within 4 weeks before the first dose of the study drug.
• People whose side effects from previous cancer treatments have not returned to near-normal levels (grade 1 or below), except for hair loss or certain nerve-related side effects.
• People who have had major surgery within 14 days before enrolment, or who have significant medical, surgical, or psychiatric conditions — including recent or active thoughts of self-harm — that the investigator considers would make participation unsafe or inappropriate.
• People who have received another experimental drug within 30 days (or 5 half-lives of that drug, whichever is longer) before the first dose of the study treatment.

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