How does cilta-cel work?

With cilta-cel, your T-cells have been enhanced to target BCMA on myeloma cells. Learn more at: How CAR T-cell Therapy Works. 

Who can receive cilta-cel? 

Adult patients with relapsed or refractory myeloma are eligible for cilta-cel if they have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.  

To learn about more factors that may influence whether CAR-T is right for you, visit: When to Consider CAR T-cell Therapy?

When will the cilta-cel infusion be ready? 

The CAR-T process takes time. After collecting your T-cells, it takes about 5 weeks for the cilta-cel infusion to be ready. 

During this waiting period, your doctor may recommend a temporary treatment called bridging therapy to control your myeloma. This may include one or more cycles of a combination like DPd (daratumumab, pomalidomide, dexamethasone) or PVd (pomalidomide, bortezomib, dexamethasone) to help keep myeloma under control until your CAR-T infusion. 

How is cilta-cel administered?

Before your cilta-cel infusion, you will receive a short course of chemotherapy with cyclophosphamide and fludarabine through an IV daily for three days. This step is called lymphodepletion, and it helps prepare your body so CAR-T works more effectively. Your cilta-cel infusion is typically given 2–4 days after this chemotherapy. If you experience serious side effects from lymphodepletion, active infections, or inflammatory disorders, the CAR-T infusion will be delayed until these side effects are resolved. 

About 30 to 60 minutes before the CAR-T infusion, you will be given acetaminophen and diphenhydramine by your healthcare team to help lower the risk of side effects. The cilta-cel infusion itself takes between 30 and 60 minutes.  

Afterward, you will be monitored closely for at least seven days for possible side effects such as cytokine release syndrome (CRS) and neurological changes.  You will also need to stay near the treatment center and avoid driving for at least two weeks after the infusion. The requirements used to be longer but were recently updated based on the FDA’s removal of the Risk Evaluation and Mitigation Strategies (REMS). 

How effective is cilta-cel for myeloma? 

Results from the phase 3 CARTITUDE-4 trial that led to cilta-cel’s FDA approval for people with relapsed/refractory myeloma who had received 1, 2, or 3 prior lines of treatment showed the following: 

• Cilta-cel reduced the risk of disease progression or death by 59% percent compared to standard therapies PVd or DPd.
• 84.6% of patients experienced an overall response, 73.1% had a complete response or better, and 60.6% were MRD negative.  

More recent data from the CARTITUDE-4 study showed long-term results at a median follow-up of 33.6 months. Regardless of whether patients had received 1, 2, or 3 lines of therapy before cilta-cel, median progression-free survival and overall survival were not reached. This means that more than half of the patients had not yet experienced the event being measured. 

Another important finding was that patients with standard and high-risk myeloma experienced the same benefits from cilta-cel.  

These findings are very encouraging, showing that cilta-cel can be effective for the majority of people with myeloma and have long-term outcomes. 

To read more recent research on cilta-cel, including what you may expect if you’re receiving this CAR-T as a 4th or subsequent line of therapy, read our article: Cilta-cel CAR T-cell Therapy: Unprecedented Long-Term Outcomes in Relapsed and Refractory Myeloma. 

Side effect profile of cilta-cel 

The chart below shows the percentage of people with myeloma who experienced side effects from cilta-cel in the CARTITUDE-4 trial. This information can help you understand what to expect and prepare for, as well as guide conversations with your care team about managing potential side effects. 

Side effect name	Percentage of patients who experienced any version of the side effect (mild to severe/grades 1-5)	Percentage of patients who experienced a severe version of the side effect that required hospital care (grades 3-5)
Hypogammaglobulinemia (low levels of antibodies)	94%	9%
Fever (Pyrexia)	79%	5%
Cytokine release syndrome	78%	3%
Musculoskeletal (muscle/bone) pain	34%	2%
Fatigue	28%	3%
Diarrhea	27%	3%
Upper respiratory tract infection	25%	1%
Viral infection	23%	4%
Headache	23%	0%
Hypotension (low blood pressure)	23%	4%
Nausea	20%	0%
Bacterial infection	15%	6%
Cough	15%	0%
Pneumonia	14%	9%
Hypoxia (low levels of oxygen in body tissues)	12%	3%
Edema (swelling in limbs from trapped fluid)	11%	1%
Encephalopathy (a group of conditions that cause brain dysfunction)	11%	2%
Constipation	10%	0%
Pain	10%	1%
Decreased appetite	10%	0%

 

Additionally, the majority of patients experienced decreased blood counts that required supportive hospital care. 

For more information on these side effects, visit: Side Effect Management of CAR T-cell Therapy for Multiple Myeloma. 

For more information on cilta-cel, check out the source below. 

• Carvykti Prescribing Information

Financial resources for cilta-cel 

To locate financial resources for cilta-cel, visit: Financial Resources for Myeloma CAR-T.