Phase 3 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 aged 18 to 75 years of any gender.
• People who have previously been diagnosed with multiple myeloma and have received 1 to 2 rounds of treatment (including treatments based on proteasome inhibitors and immunomodulatory drugs), where each round included at least one full cycle, and whose disease has progressed during or within 12 months after their most recent myeloma treatment.
• People whose myeloma stopped responding to the drug lenalidomide during a previous treatment.
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physically strenuous activity (confirm with trial site).
• People whose blood counts, liver function, kidney function, clotting levels, blood oxygen levels, and heart pumping function all meet specific minimum thresholds as measured by blood tests before joining (confirm with trial site for exact values).
• People who agree to use effective contraception throughout the trial (excluding natural family planning methods).
• People who are willing to read and sign an ethics-approved consent form before any screening procedures begin.

Who may not be able to join:

• People who have used or needed long-term immune-suppressing medications (such as cyclosporine or systemic steroids) within 14 days before joining, although low-dose replacement steroids, short-term steroids, or steroids applied to the skin or inhaled are generally permitted.
• People who had an autologous stem cell transplant (using their own stem cells) within 12 weeks before joining, or who have ever had an allogeneic stem cell transplant (using a donor's stem cells).
• People who received certain anti-cancer treatments too recently before joining, including immunomodulatory drugs within 7 days, plasma exchange, radiotherapy (other than local bone treatment), chemotherapy, proteasome inhibitors, or other experimental drugs within 14 days, myeloma-targeted antibody treatments within 21 days, or any other anti-cancer therapy within 14 days or within 5 half-lives of the drug (whichever is shorter).
• People with a significant heart condition.
• People with an unstable or serious illness affecting the liver, kidneys, or metabolism that requires ongoing medication, as assessed by the treating doctor.
• People with a known allergy or intolerance to any of the study drugs or their ingredients, including Eque-cel components (DMSO and albumin), fludarabine, cyclophosphamide, tocilizumab, dexamethasone, or pomalidomide.
• People who have had another cancer (other than multiple myeloma) within the past 5 years, with some exceptions for certain early-stage or fully treated cancers such as cervical carcinoma in situ, certain skin cancers, localised prostate cancer, breast ductal carcinoma in situ, or papillary thyroid cancer — all following complete surgical treatment.
• People who are suspected or confirmed to have myeloma that has spread to the central nervous system (brain or spinal cord) at the time of screening.
• People who have plasma cell leukaemia, Waldenström macroglobulinaemia, POEMS syndrome, or primary amyloidosis at the time of screening.
• People with certain patterns of myeloma that has spread outside the bone marrow (extramedullary disease), particularly disease outside the bone or larger tumour deposits, as assessed by the trial site (confirm with trial site for specific size thresholds).
• People who had major surgery within 2 weeks before joining, or who are expected to have major surgery within 2 weeks after starting treatment (minor procedures under local anaesthetic may be permitted).
• People with an infection that cannot be controlled.
• People who test positive for certain infections, including active hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus (CMV).
• People who are pregnant or breastfeeding.
• People who have had a central nervous system disorder within 6 months before signing the consent form.
• People who still have significant side effects from previous cancer treatments that have not recovered to a mild level or returned to baseline (with some exceptions such as hair loss or mild nerve-related symptoms).
• People who have any other condition that the treating doctor considers unsuitable for participation.

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