Early Phase 1 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 sign a consent form, attend scheduled visits, and agree to long-term follow-up for up to 15 years as required by health regulations
• People aged 18 years or older
• People who have plasma cell leukemia (a type of blood cancer) either after initial treatment, or whose disease has come back or stopped responding to treatment
• People whose disease can be measured through tests to track its progression
• People with an expected survival of more than 12 weeks
• People with a good general health and activity level, as measured by a standard medical scoring system (score of 0 or 1 on the ECOG scale — confirm with trial site)
• People whose heart, liver, kidneys, and other organs are functioning well enough to meet the trial's requirements (confirm with trial site)
• Women of childbearing age who have a negative pregnancy test before starting treatment, agree to use reliable contraception for at least 1 year after treatment, and agree not to donate eggs for at least 1 year after treatment
• Men who agree to use reliable contraception for at least 1 year after treatment if sexually active with a woman who could become pregnant, and agree not to donate sperm for at least 1 year after treatment

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People who have tested positive for HIV, or who have active hepatitis B or C infection (a past hepatitis B or C infection that has been treated may be acceptable if the virus is no longer detectable on tests)
• People with any active infection that is not under control, including active tuberculosis
• People still experiencing significant side effects from previous treatments that have not returned to a mild or resolved level (with some exceptions, such as hair loss)
• People with significant medical conditions, abnormal test results, or mental health conditions that could affect their ability to safely participate in the trial
• People who have had a donor stem cell transplant at any point, or their own stem cell transplant within the past 12 weeks
• People who received treatment for their disease within 14 days (or within a timeframe based on the specific drug used) before the pre-treatment phase begins
• People who received any cell-based therapy within 28 days before signing the consent form
• People who have taken high-dose steroid medications (more than the equivalent of 15 mg/day of prednisone) within 7 days before signing the consent form (skin-applied steroids may be exempt)
• People who received any live, inactivated, or mRNA vaccine within 4 weeks before signing the consent form
• People who had major surgery within 2 weeks before signing the consent form, or who have major surgery planned during the trial or within 4 weeks after receiving the study treatment
• People who are allergic or intolerant to the medicines used in this trial, including the pre-treatment drugs, a medication called tocilizumab, or a component called DMSO used in the preparation of the trial treatment — or people who have had a severe allergic reaction (such as anaphylactic shock) to any treatment in the past
• People diagnosed with certain related blood or protein disorders, including secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis
• People who have had certain serious heart conditions within the 6 months before screening (confirm specific conditions with trial site)
• People who need extra oxygen to maintain normal oxygen levels, or people with a lung condition called COPD where breathing tests show significantly reduced lung function
• People with active autoimmune diseases (such as psoriasis or rheumatoid arthritis) that require ongoing immune-suppressing treatment
• People who have or have had a second type of cancer in addition to their blood cancer, unless that second cancer has been successfully treated and has been in full remission for at least 2 years (certain low-risk skin cancers, non-spreading prostate cancer, and some other early-stage cancers may be exceptions — confirm with trial site)
• People with active or suspected cancer that has spread to the brain or nervous system
• People who are unable or unwilling to follow the trial requirements, or who are considered unsuitable for any other reason by the trial doctors

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