How it is administered
Idecabtagene vicleucel is administered as a single intravenous (IV) infusion. The medication is prepared from your own blood cells, which are collected through a process called leukapheresis. These cells are then genetically modified in a laboratory to target multiple myeloma cells and are infused back into your bloodstream. The recommended dose is between 300 to 510 million CAR-positive T cells. Before receiving the infusion, you will receive a short course of chemotherapy (cyclophosphamide and fludarabine) to prepare your body for the treatment. You will also be given medications like acetaminophen and an antihistamine before the infusion to help prevent reactions.
How it works
Idecabtagene vicleucel is a type of CAR T-cell therapy. It uses your own T cells (a type of white blood cell) that are collected and then genetically modified in a laboratory to recognize and attack multiple myeloma cells. The modification involves adding a chimeric antigen receptor (CAR) that specifically targets a protein called BCMA (B-cell maturation antigen) found on the surface of myeloma cells. Once these modified T cells are infused back into your body, they seek out and destroy the cancerous plasma cells by binding to BCMA. This process can lead to rapid reduction in tumor markers and, in many cases, a significant response in multiple myeloma that has not responded to other treatments. The therapy can also cause the T cells to multiply and remain in your body for some time, continuing to fight the cancer.
Common side effects
- Fever (pyrexia)
- Cytokine release syndrome (CRS)
- Low levels of antibodies (hypogammaglobulinemia)
- Infections (including unspecified, viral, and bacterial)
- Musculoskeletal pain
- Fatigue
- Low white blood cell counts (neutropenia, leukopenia, lymphopenia)
- Low platelet counts (thrombocytopenia)
- Low red blood cell counts (anemia)
- Low appetite
- Nausea, diarrhea, constipation
- Headache, dizziness, confusion (encephalopathy)
- Swelling (edema)
- Chills
- Upper respiratory tract infection
- Cough, shortness of breath (dyspnea)
- Hypotension (low blood pressure)
- Rash
- Sleep disorders
- Secondary malignancies (rare)
Serious side effects can include severe CRS, neurological toxicities, prolonged low blood counts, and serious infections.
Who Should take it
Idecabtagene vicleucel is indicated for adults with multiple myeloma that has come back (relapsed) or has not responded (refractory) after at least two previous lines of therapy. These prior treatments must include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This therapy is considered for people whose disease is difficult to treat and who have limited options left after standard treatments. It is not used as a first-line therapy and is reserved for those who have already tried other medications without success.
Who should not take it
There are no absolute contraindications listed for idecabtagene vicleucel, but it should not be given to people with active infections or inflammatory disorders at the time of planned infusion. It is not recommended for use in pregnant women, as the effects on the fetus are unknown and could be harmful. The safety and effectiveness in children under 18 years old have not been established. People with certain health conditions, such as severe heart, lung, or liver problems, may not be suitable candidates for this therapy. Your healthcare team will carefully evaluate your overall health before recommending this treatment.
Commonly used with
Before receiving idecabtagene vicleucel, patients are typically given a short course of chemotherapy with cyclophosphamide and fludarabine to prepare the body for the CAR T-cell infusion. During or after treatment, supportive medications such as acetaminophen, antihistamines, and sometimes corticosteroids may be used to manage side effects. Tocilizumab, a medication that treats CRS, is often kept on hand and may be administered if needed.
Commonly tested with
Idecabtagene vicleucel has been tested in combination with lymphodepleting chemotherapy agents (cyclophosphamide and fludarabine) as part of the treatment protocol. Supportive medications such as tocilizumab (for CRS) and corticosteroids (for severe side effects) are also commonly used in clinical studies. Other standard multiple myeloma regimens (such as daratumumab, pomalidomide, dexamethasone, and others) have been used as comparators in clinical trials.