CARVYKTI® (ciltacabtagene autoleucel) is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. It is used when at least one other treatment has not worked or has stopped working. CARVYKTI® is a medicine made from your own white blood cells, which have been changed (genetically modified) to recognize and attack your multiple myeloma cells.
If you have not been prescribed CARVYKTI® yet, you can use this simple tool to find out if you may be eligible for treatment. Answer the questions below and speak with your doctor to see if you are eligible to receive CARVYKTI®.
Consider the lines of treatment you (or the person you care for) have received to treat multiple myeloma. Has the most recent treatment not worked or stopped working?
You may be a candidate for treatment with CARVYKTI®. Talk to your doctor about CARVYKTI® and whether it's right for you.
You can sign up for updates to receive tailored communications and support materials about CARVYKTI® designed for your needs. Please also explore the treatment process below to become more familiar with how CARVYKTI® is received.
You can also click here to find a CARVYKTI® Certified Treatment Center
There may still be treatment options available that may help control your multiple myeloma before it's time for you and your doctor to consider CARVYKTI®. If your disease returns following at least one treatment regimen that contains a proteasome inhibitor and an immunomodulatory agent, and you have not responded to lenalidomide, talk to your doctor to see if CARVYKTI® is an option for you.
There may still be treatment options available that may help control your multiple myeloma before it's time for you and your doctor to consider CARVYKTI®. If your disease returns following at least one treatment regimen that contains a proteasome inhibitor and an immunomodulatory agent, and you have not responded to lenalidomide, talk to your doctor to see if CARVYKTI® is an option for you.
CARVYKTI® is an individualized treatment that is prescribed and infused at a Certified Treatment Center. Your primary oncologist will help you set up a consultation at a Certified Treatment Center, which will determine your eligibility and provide your treatment with CARVYKTI®. You'll still remain in contact and may keep your scheduled appointments with your primary oncologist, who will continue to be involved in your care throughout this process and especially when you return home for longer-term monitoring and follow-up care.
Therapy with CARVYKTI® is a 5-step process that generally takes about 2 to 3 months to complete.*
STEP 1: CELL COLLECTION
~3 TO 6 HOURS
Some of your blood is drawn into a machine that separates the white and red blood cells, collects some of the white blood cells (including T cells), and returns the rest of the blood into your body. This process is called leukapheresis(loo-kuh-fur-ee-sis).This process may take ~3 to 6 hours and may need to be repeated until the process is complete.
Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.†
Important Safety Information
In a study comparing CARVYKTI® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI® and after treatment with CARVYKTI®. The reasons for death were progression of multiple myeloma and side effects of the treatment. Talk to your doctor if you have any questions about your health condition or treatment.
*Timing and outcomes of manufacturing may vary.
†208/208 patients in the CARTITUDE-4 study received bridging therapy.
STEP 2: GENETICALLY MODIFYING YOUR T CELLS
~4 TO 5 WEEKS*
Your white blood cells are frozen and sent to a manufacturing site, where the T cells are separated out and customized into your CARVYKTI® CAR-T cells. This is done by genetically modifying your T cells to be able to recognize BCMA on the surface of multiple myeloma cells. Your CARVYKTI® CAR-T cells are then frozen and sent to your CARVYKTI® Certified Treatment Center.
Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.†
Important Safety Information
In a study comparing CARVYKTI® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI® and after treatment with CARVYKTI®. The reasons for death were progression of multiple myeloma and side effects of the treatment. Talk to your doctor if you have any questions about your health condition or treatment.
†208/208 patients in the CARTITUDE-4 study received bridging therapy.
STEP 3: PRE-INFUSION TREATMENT
3 DAYS
A few days before your infusion of CARVYKTI®, you’ll receive low-dose chemotherapy infusions with cyclophosphamide and fludarabine. These infusions will help prepare your body for the CAR-T infusion. Each of these infusions will be given to you once a day for 3 days. These infusions are given to help clear out some of your white blood cells to make the necessary space in your immune system for CARVYKTI®. This is also known as lymphodepleting chemotherapy.
Important Safety Information
In a study comparing CARVYKTI® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI® and after treatment with CARVYKTI®. The reasons for death were progression of multiple myeloma and side effects of the treatment. Talk to your doctor if you have any questions about your health condition or treatment.
*Timing and outcomes of manufacturing may vary.
STEP 4: ONE-TIME CARVYKTI® INFUSION
~30 TO 60 MINUTES
About a month after your initial cell collection, and 2 to 4 days after your last low-dose chemotherapy, you’ll be given your CARVYKTI® through a one-time intravenous infusion that takes approximately 30 to 60 minutes. Your healthcare provider will guide you through what your infusion day will be like.
Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.†
Important Safety Information
In a study comparing CARVYKTI® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI® and after treatment with CARVYKTI®. The reasons for death were progression of multiple myeloma and side effects of the treatment. Talk to your doctor if you have any questions about your health condition or treatment.
*Timing and outcomes of manufacturing may vary.
†208/208 patients in the CARTITUDE-4 study received bridging therapy.
STEP 5: MONITORING
4 WEEKS AND BEYOND
After your infusion of CARVYKTI®, your healthcare provider at the CARVYKTI® Certified Treatment Center will closely monitor you daily for 10 days following infusion for any signs or symptoms of a reaction to treatment.
You should plan to stay close to the location where you received your treatment for at least 4 weeks. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur. You may be hospitalized if you develop serious side effects until your side effects are under control and it is safe for you to leave the hospital.
Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule. After this 4-week monitoring period, your healthcare providers will continue to provide care and partner with you to create a plan for long-term monitoring and regular follow-ups. Let your healthcare providers know if you’re not feeling well. Refrain from driving or hazardous activities for at least 8 weeks following treatment with CARVYKTI®.
Important Safety Information
In a study comparing CARVYKTI® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI® and after treatment with CARVYKTI®. The reasons for death were progression of multiple myeloma and side effects of the treatment. Talk to your doctor if you have any questions about your health condition or treatment.
Important Safety Information
In a study comparing CARVYKTI® to standard therapy, there was a higher rate of
death in the first 10 months in the CARVYKTI® arm (14%) compared to the
standard therapy arm (12%). The increased rate of deaths occurred before
receiving CARVYKTI® and after treatment with CARVYKTI®. The reasons for death were progression of multiple myeloma and side effects of the treatment.
Talk to your doctor if you have any questions about your health condition or treatment.
Watch this immersive video that guides patients and care partners through what to expect at each stage of the CARVYKTI® journey.
SEE HOW YOUR CARVYKTI® CAR-T CELLS ARE MADE
Watch this animated video to learn more about the CARVYKTI® manufacturing process.
PLANNING FOR TREATMENT WITH CARVYKTI®
Traveling away from home for medical care can be financially and logistically challenging. Support is available for eligible patients and their care partners.
The MyCARVYKTI® Patient Support Program
The MyCARVYKTI® Patient Support Program, sponsored by Janssen Biotech, Inc., and Legend Biotech, is designed to help eligible patients prescribed CARVYKTI® and their care partners with support during treatment.
Patients who meet financial and other eligibility requirements, and their care partners, may receive:
Assistance with transportation, lodging, and out-of-pocket costs related to meals and other travel expenses associated with treatment at the CARVYKTI® Certified Treatment Center
Support from MyCARVYKTI® Patient Support Specialists, who are available to help guide eligible patients through the enrollment process and assist with program benefits
Have someone like a friend or care partner go with you to appointments.
A support system can make your treatment experience seem less overwhelming.
Plan your travel and lodging to stay near your CARVYKTI® Certified Treatment Center.
Your healthcare providers will monitor you closely for 4 weeks after you receive CARVYKTI® to watch for side effects.
Wear loose, comfortable clothing.
Your doctor will need access to a vein to place the needle and catheter in your arm.
Bring a book, music, or something to do.
Leukapheresis can take ~3 to 6 hours and may need to be repeated. The CARVYKTI® infusion can take up to an hour. Consider activities during the monitoring period after infusion, too.
Have someone like a friend or care partner go with you to appointments.
A support system can make your treatment experience seem less overwhelming.
Plan your travel and lodging to stay near your CARVYKTI® Certified Treatment Center.
Your healthcare providers will monitor you closely for 4 weeks after you receive CARVYKTI® to watch for side effects.
Wear loose, comfortable clothing.
Your doctor will need access to a vein to place the needle and catheter in your arm.
Bring a book, music, or something to do.
Leukapheresis can takes ~3 to 6 hours and may need to be repeated. The CARVYKTI® infusion can take up to an hour. Consider activities during the monitoring period after infusion, too.
Your role in supporting the person you care for—the encouragement, emotional support, and practical assistance you provide—makes you an important part of the treatment experience.
You may need to help the person you care for with:
Monitoring and tracking side effects
Scheduling appointments
Providing transportation to appointments and keeping them company
Helping communicate with the healthcare provider (for example, providing medical and insurance information, asking questions)
Responsibilities at home
Emotional support and having someone to talk with
Managing their schedule and letting visitors know when they do or don't feel up to seeing them
You don't have to manage this alone. Support is available to help you along the way, and you may want to identify friends or family who can help you as well.
