Phase 2 Myeloma Trial, Recruiting

Written by an AI model from the 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 diagnosed with ultra-high-risk multiple myeloma who are between 18 and 70 years old and are considered suitable for a stem cell transplant using their own cells
• People whose myeloma has specific high-risk genetic features, such as a large proportion of cells with a deleted chromosome 17p, or two or more high-risk genetic changes (confirm with trial site for full list)
• People whose myeloma did not respond well enough to their first treatment (standard three-drug therapy)
• People whose myeloma came back or got worse within 6 months of their best response to first-line treatment
• People diagnosed with plasma cell leukemia (a form of myeloma where a significant number of abnormal plasma cells are found in the blood)
• People with myeloma that has spread outside the bone marrow to soft tissues not attached to bone
• People classified as stage R2-ISS-IV or MPSS-IV (a high-risk disease staging classification — confirm with trial site)
• People who have given their own written consent, or whose legal guardian has done so on their behalf
• People whose liver, kidney, blood clotting, and blood cell levels fall within the ranges required by the trial (confirm with trial site for specific values)
• People whose heart pumping function is at or above 45% on an echocardiogram
• People whose blood oxygen level is at or above 92%
• People with a general health performance score of 0 or 1 on the ECOG scale (meaning fully active or restricted in strenuous activity only)
• People with an estimated life expectancy of at least 3 months
• Women who are able to become pregnant must have a negative pregnancy test and must not be breastfeeding; both men and women must use effective contraception for 24 months after receiving the cell treatment

Who may not be able to join:

• People with a known allergy to any component of the cell therapy product used in this trial
• People with serious heart conditions, including a heart attack, heart procedure, or stent placement within the past 6 months, unstable chest pain, severe irregular heartbeat, serious non-ischemic heart muscle disease, or advanced heart failure (NYHA class III or IV)
• People who have previously had an autologous or donor stem cell transplant
• People who have had a stroke or seizure within the 6 months before signing the consent form
• People with autoimmune disease, immune deficiency, or any condition requiring medications that suppress the immune system
• People who have had another cancer (other than multiple myeloma) within the past 3 years, with some exceptions for certain fully treated early-stage cancers (confirm with trial site)
• People with an active infection that is not under control
• People with unstable serious conditions affecting the liver, kidneys, or metabolism that require ongoing medication
• People who, in the week before lymphocyte collection, have active hepatitis B virus in their blood, active hepatitis C infection, HIV infection, active syphilis, or active cytomegalovirus (CMV) infection
• People who have been taking more than 5mg per day of prednisone (or an equivalent steroid) in the week before lymphocyte collection
• People who have previously received any CAR-T cell therapy or other genetically modified T cell treatment
• People who have previously received any therapy targeting a protein called BCMA
• People who have received a live vaccine within 4 weeks before signing the consent form
• People with a history of alcohol abuse, drug abuse, or a mental illness
• People who the trial investigators consider unsuitable for any other reason

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