Study on Whether Ide-cel (bb2121) Can Be Made from People with Multiple Myeloma Who Have Had a Blood Cell Transplant

Inclusion Criteria

Cohort 1:

• Patients with multiple myeloma who have had at least four previous treatments, including specific drugs, and have measurable disease before a recent high-dose melphalan transplant.
• Measurable disease can be shown by certain levels of proteins in the blood or urine, visible tumors on scans, or a specific percentage of cancer cells in the bone marrow.

Cohort 2:

• Patients with confirmed multiple myeloma who have had at least four previous treatments and a bone marrow transplant, with minimal residual disease in the bone marrow.
• Must be over 18 years old and in good health with a performance score of 70 or higher.
• Must have recovered from previous treatment side effects and not be on certain medications before cell collection.
• Must meet specific blood and organ function criteria.
• Women must not be pregnant and agree to use effective birth control. Men must agree to use condoms and not donate sperm.
• Must be willing to follow study requirements, including long-term follow-up.

Before Chemotherapy:

• Women must have a negative pregnancy test.
• Must meet specific blood and organ function criteria.
• Must not have recent severe bleeding or active infections.
• Must not be on certain medications or have specific health issues.
• Must have available manufactured cells for treatment.

Before Ide-Cel or Cilta-Cel Infusion:

• Treatment may be delayed if there are signs of infection, fever, breathing issues, heart problems, or other severe health changes.

Exclusion Criteria

• Recent treatments like plasmapheresis, major surgery, or radiation therapy.
• Previous organ transplant requiring immune suppression.
• Recent severe bleeding or need for ongoing blood thinners.
• Certain brain or nervous system conditions.
• Other specific blood disorders or significant amyloidosis.
• Severe heart conditions or recent heart issues.
• Active autoimmune diseases requiring immune suppression.
• Positive tests for HIV, hepatitis B or C, or acute hepatitis A.
• Recent or untreated cancers, except for certain skin cancers.
• Women who are pregnant or breastfeeding.
• Allergies to study medications.
• Serious medical or psychiatric conditions.
• Uncontrolled infections.
• Inability to provide consent or follow study requirements.
• Recent anti-myeloma therapy or steroid use before cell collection.