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 multiple myeloma that has come back or stopped responding to treatment.
• People whose bone marrow or tumour samples show that at least 30% of plasma cells carry a protein called BCMA (confirmed through specialised laboratory testing sent to an approved lab).
• People whose myeloma did not respond, or got worse, after at least 3 treatment cycles of specific standard therapies (bortezomib or lenalidomide), and whose disease progressed more than 30 days after their last treatment.
• People who are not currently recommended for a stem cell transplant, or who have declined one.
• People whose disease activity can be measured and meets at least one specific laboratory or imaging threshold set by the trial (confirm with trial site for details).
• People who are reasonably well and able to carry out daily activities, rated 0 or 1 on a standard medical fitness scale.
• People who have good enough vein access for blood collection procedures, with no medical reason preventing this.
• People whose blood counts meet minimum levels: white blood cells at or above 1.5 × 10⁹/L and platelets at or above 45 × 10⁹/L, without needing ongoing supportive treatment to reach those levels.
• People whose kidney function blood test (creatinine) is within an acceptable range (no more than 1.5 times the upper limit of normal), without supportive treatment.
• People whose liver function tests (ALT and AST) are within an acceptable range (no more than 2.5 times the upper limit of normal), without supportive treatment.
• People expected to survive at least 12 weeks.

Who may not be able to join:

• People who received certain immune-clearing chemotherapy drugs (such as cyclophosphamide or fludarabine) within 2 weeks before enrolment or cell collection, or who previously received CAR-T cell therapy targeting CD19 or BCMA, or who received certain cell-based or bispecific antibody therapies within 8 weeks before treatment.
• People who received a chemotherapy drug called bendamustine within the 6 months before treatment.
• People who have active, uncontrolled infections, including active tuberculosis, a detectable level of hepatitis B virus in the blood (at or above 1,000 copies/mL), or who test positive for hepatitis C or HIV.
• People who have had an active infection in the 72 hours before treatment starts (people taking preventive antibiotics, antifungals, or antivirals without signs of active infection may still be considered, provided those medications are not on the trial's prohibited list).
• People currently taking cyclosporine or steroid medications by mouth or injection (such as dexamethasone) — inhaled steroids are not excluded.
• People with kidney function outside the acceptable range, with a creatinine level more than 1.5 times the upper limit of normal.
• People with liver function outside the acceptable range, with liver enzymes (AST and/or ALT) more than 2.5 times the upper limit of normal and direct bilirubin more than 1.5 times the upper limit of normal.
• People with a very low sodium level in the blood (below 125 mmol/L).
• People with a low potassium level in the blood (below 3.5 mmol/L), unless potassium supplements taken before enrolment bring the level back to an acceptable range.
• People who are pregnant or breastfeeding.
• People with other serious health conditions that could make participation unsafe, such as nervous system disorders, severe heart failure, a heart attack in the past 6 months, unstable heart rhythm or chest pain, stomach ulcers, or active autoimmune disease (confirm with trial site for the full list).

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