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:

• Adults aged 18 or older who have multiple myeloma that has come back or stopped responding to treatment, and whose disease can be measured through specific blood, urine, or protein tests.
• People who have already been through at least 4 previous rounds of treatment, including specific types of drugs known as immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies.
• People who previously received a type of cell therapy called BCMA CAR-T, provided at least 6 months have passed since that treatment.
• People who previously used a TNF-alpha inhibitor (a type of anti-inflammatory drug) for another condition, provided at least 6 months have passed since that treatment.
• People whose blood counts and organ function meet specific minimum levels — including red blood cells, white blood cells, platelets, liver function, and kidney function — as determined by blood tests.
• People whose heart is functioning adequately, including a heart pumping strength (ejection fraction) of at least 30%, no uncontrolled irregular heartbeats, no severe heart failure, and a normal heart rhythm reading on a specific heart tracing test.
• People who test negative for latent (inactive) tuberculosis at the screening stage.
• People who are well enough to carry out basic daily activities, as measured by a standard health performance scale (confirm with trial site).
• People who are able and willing to give formal written consent to participate.
• Women who could become pregnant must agree to use two forms of reliable contraception starting 4 weeks before treatment and continuing for 6 months after treatment ends, and must have a negative pregnancy test before starting and at regular intervals during the trial.
• Male participants who are sexually active with women who could become pregnant must use a condom for the duration of the study and for 6 months after treatment ends, and must not donate sperm during this time.
• Breastfeeding is not permitted during participation.

Who may not be able to join:

• People diagnosed with certain other blood or plasma cell conditions, including Waldenström macroglobulinemia, primary AL amyloidosis, primary plasma cell leukaemia, or POEMS syndrome.
• People currently taking corticosteroid medications (such as prednisone), unless taken at a low dose for a hormone-related medical need.
• People using complementary or alternative medicines that could interfere with how the study drugs work or affect the safety results.
• People who have received a live vaccine within 4 weeks before starting treatment, or who would need one during or within 4 weeks after treatment (live vaccines cannot be given at the same time as one of the study drugs).
• People with currently active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, or who have used certain biologic medications to treat these conditions within the past 6 months.
• People with a history of a severe allergic reaction to any of the following medications: etanercept, infliximab, adalimumab, certolizumab pegol, or golimumab.
• People with serious lung conditions, including severe chronic obstructive pulmonary disease (COPD) or moderate-to-severe asthma that is not well controlled.
• People with serious heart problems, including very low heart pumping strength, certain abnormal heart rhythm patterns, a prolonged electrical signal on a heart tracing test, a heart attack within the past 6 months, or unstable chest pain.
• People with active tuberculosis, any recent close contact with someone with active tuberculosis, active invasive fungal infections, other active serious infections, or a history of certain unusual infections.
• People with a history of or currently active nerve-related conditions affecting the protective coating of nerves, such as multiple sclerosis, Guillain-Barré syndrome, optic neuritis, or related disorders.
• People who have taken experimental or targeted treatments within the past 2 weeks (or within 5 half-lives of the drug, whichever is shorter) and have not yet recovered from side effects.
• People who have had major surgery within the past 2 weeks or who have not yet recovered from surgery.
• People known to be living with HIV or hepatitis C.
• People with currently active hepatitis B infection.
• People with a history of another cancer that is currently active or requires ongoing treatment (exceptions may apply for certain non-invasive skin cancers — confirm with trial site).
• People with a significant history of not following medical instructions, or who are unable or unwilling to follow the study requirements.
• People with any other medical condition, mental health condition, or substance use issue that the trial doctors believe would interfere with safe participation or the reliability of the results.

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