An Exciting New Option for Some Multiple Myeloma Patients
- The CAR T-cell therapy Carvykti (generic name cilta-cel) significantly reduced the risk of disease progression in multiple myeloma patients whose cancer had returned after 1-3 previous treatments, according to an exciting new study.
- The data supports the use of CAR T-cell therapy earlier in the treatment plan. Right now it’s approved for multiple myeloma patients as a fifth treatment option.
- Chimeric antigen receptor (CAR) T-cell therapy reengineers the patient’s immune cells in a lab to be able to find and destroy cancer cells.
- CAR T-cell therapy is an innovative treatment that can be incredibly expensive, so it’s important for patients to understand what their insurance covers and what they may have to pay for out of pocket.
- Resources and organizations may be available to help you if you are struggling to pay for care you need.
- Patients are encouraged to talk to their doctor about whether they’re a good candidate for CAR T-cell therapy, and if a therapy like Carvykti makes sense for them earlier in your treatment plan.
A relatively new drug called cilta-cel (sold as brand name Carvykti) could change the treatment approach for patients whose cancer has returned after (relapsed) or not responded to (refractory) one to three previous therapies already.Read More
Expert Multiple Myeloma Resources
This was the first study to look at using CAR T-cell therapy for this type of multiple myeloma after the first relapse, said lead author Dr. Binod Dhakal, associate professor of medicine at the Medical College of Wisconsin.
This data helps support using Carvykti earlier in the treatment plan, allowing patients to benefit from its efficacy sooner.
Dr. Sagar Lonial, Chair and Professor of the Department of Hematology and Medical Oncology at the Winship Cancer Institute, told SurvivorNet that the data is “very exciting and suggests that the efficacy of CAR T will not just be in later lines, but potentially early in the disease course.”
“I think what this does is open up discussions for use after one or two lines, where we know the current combinations are perhaps suboptimal,” Dr. Lonial said.
Dr. Dhakal agreed that this study shows Carvykti can be a viable option “earlier in the disease journey, when patients may experience better outcomes. This brings us hope for long-term remission through personalized immunotherapy, which is quite promising.”
For multiple myeloma patients, this means it may be beneficial to talk with your doctor about whether you’re a good candidate for CAR T-cell therapy, and if a therapy like Carvykti makes sense for you earlier in your treatment plan.
It’s important to note, however, that CAR T-cell therapy can be incredibly expensive and is not available everywhere. Therapy cost and availability should be considered when creating a treatment plan (more on that below).
The data, from the CARTITUDE-4 trial, was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, the largest cancer conference in the world.
What Is CAR T-Cell Therapy?
CAR T-cell therapy, or chimeric antigen receptor T-cell therapy, is a type of treatment that reprograms immune cells to fight cancer.
The immune system has its own way of tracking down harmful invaders like germs or cancer. It looks for proteins called antigens on the surface of these cells. Then it sends out an army of white blood cells leukocytes to destroy the invaders.
But sometimes the immune system can't find the cancer on its own. Cancer cells can devise tricky ways of cloaking themselves and hiding.
The immune system's main soldier in fighting off viruses and bacteria is the T cell. Unfortunately, the body's T cells aren't typically strong enough to fight off myeloma cells.
But with CAR T-cell therapy, scientists extract the T cells from a patient's body and re-engineer them in a lab, combining them with the man-made chimeric antigen receptor. Now CAR T cells, the reprogrammed immune cells are given back to the patient to fight the cancer.
This innovative therapy has been approved to treat several different types of blood cancer, including leukemia and lymphomas.
Meanwhile, your care team will monitor you throughout the process and for some time after you receive your new CAR T cells to watch for any side effects or negative reactions.
Common side effects of CAR T-cell therapy include:
- Muscle or joint pain
- Nausea, vomiting or diarrhea
- Rapid heartbeat
- Low blood pressure
- Significant loss of appetite
The treatment may also cause nervous system symptoms like confusion, tremors or shaking, trouble speaking and loss of balance.
But it's important to note that CAR T-cell therapy can still lead to serious side effects, including the risk of infections or bleeding and allergic reactions.
There is also the possibility of something called cytokine release syndrome, which can cause a high fever, low oxygen levels, and low blood pressure. This can be a serious medical condition that requires promt identification and treatment by experts.
About one-quarter or more of people who go on CAR T-cell therapy will have some form of CRS. The good news is, very serious reactions are rare.
Doctors are studying methods to prevent CRS, in the meantime taking great precautions to monitor patients. In very serious cases, there are medications that can relieve symptoms.
About The New Study
The efficacy of Carvykti was demonstrated in the phase III CARTITUDE-4 randomized, double-blind, clinical trial. A phase III trial offers the highest level of evidence for the benefit of a new treatment.
The study enrolled 419 lenalidomide-refractory multiple myeloma patients. All the patients had received one to three previous lines of treatment. Patients were divided into two groups:
- 208 received the new drug Carvykti.
- 211 received a standard of care therapy, such as the proteasome inhibitor or monoclonal antibody mentioned above.
At a median follow-up of 16 months, a 74% reduction in the risk of disease progression or death was observed in the group that received the CAR T-cell therapy.
Dr. Dhakal said the study showed a “strong clinical benefit compared with the current standard of care.” He added that it “significantly reduced” the risk of disease progression or death.
“To see such promising results carried tremendous hope for patients and the myeloma community of professionals caring for patients,” lead author Dr. Binod Dhakal told SurvivorNet.
WATCH: Clinical Trials Using CAR T-Cell Therapy Are Extremely Promising
Getting CAR T-Cell Therapy
CAR T-cell therapy is a relatively new and incredibly innovative therapy, and it comes with a steep price tag. Experts estimate that CAR T-cell therapy can cost anywhere between $500,000 and $1,000,000.
CAR T-cell therapy is exclusively available at certified centers, and it is essential to reside within a maximum distance of two hours from the center for at least four weeks, as your care team will need to monitor you throughout the process.
If you do not live in proximity to a treatment center, you and your caregiver may need to undertake extensive travel to receive the treatment, which could entail additional expenses for temporary accommodation. In such cases, there is also a possibility of income loss if you are unable to work during this period.
While many private health insurance plans provide coverage for CAR T-cell therapy, some plans do not cover it at all, while others offer limited coverage. Medicare (federal health insurance for those 65 and older) includes CAR T-cell therapy within its coverage, and Medicaid (public health insurance for people with low income and resources) covers it in specific states.
However, even if your insurance plan covers CAR T-cell therapy, you may still have out-of-pocket expenses, such as deductibles and other costs.
Prior to undergoing CAR T-cell treatment, it is crucial to consult with your health insurance provider to determine the extent of coverage and the expenses you might be responsible for down the line.
Your medical center can initiate the process by submitting the necessary paperwork to your insurance company, and they may also provide an estimate of your out-of-pocket costs.
Additionally, it is advisable to inquire whether your health insurance company offers benefits for travel and lodging. Although your plan might cover medical expenses, it may not include the costs associated with traveling to and residing near a certified center.
Patients should know, though, that there are people and organizations available to help you if you are struggling to pay for care you need. Social workers can help you navigate your bills and payments, and national non-profits exist to help some people cover their bills.
SurvivorNet has put together a list of financial resources that may be able to help you pay for the cost of your cancer care.
What Is Multiple Myeloma?
Multiple myeloma is a type of blood cancer characterized by the proliferation of plasma cells, a specific type of mature white blood cells found in the bone marrow that play a vital role in combating infections.
Normally, these plasma cells produce proteins to support the immune system in its fight against harmful microorganisms. However, in multiple myeloma, cancerous plasma cells grow uncontrolled within the bone marrow, displacing healthy white blood cells.
Consequently, the immune system becomes compromised, leading to fatigue, infections, low blood counts, anemia and several other symptoms.
As the cancerous cells, known as myelomas, expand in the bone marrow, they can lead to fractures. Moreover, these abnormal plasma cells release excessive amounts of antibodies into the bloodstream, which ultimately accumulate in the kidneys for filtration and can cause damage, even leading to renal failure.
Multiple Myeloma Treatment
Not everyone with multiple myeloma needs treatment right away. If you have smoldering multiple myeloma (an early, precancerous form of myeloma), your doctor might simply monitor you regularly, to see if your disease progresses.
If you develop symptoms or your doctor thinks you need treatment, there are many options. Which of these treatments you receive, and how they are sequenced, depend on several factors.
Standard treatment options may include:
- Bone marrow (or stem cell) transplant
- Targeted therapy
- Biologic therapy (immunotherapy)
Whether or not your doctor decides you are a good candidate for a bone marrow transplant, you may initially be treated with a combination of therapies, like targeted therapy, immunotherapy, steroids, and sometimes chemo, according to Mayo Clinic.
Then, you may undergo the transplant if you’re a good candidate, and then your doctor may put you on a maintenance regimen, such as targeted therapy or immunotherapy, to help keep the cancer from coming back.
If your myeloma continues to relapse or doesn’t respond to treatment, it’s encouraging to know that new therapies like CAR T-cell therapy are becoming available to an increasing number of patients.
Questions to Ask Your Doctor About Multiple Myeloma and CAR T-Cell Therapy
Here are some questions you may consider asking your doctor to help understand your situation and whether CAR T-cell therapy may make sense for you:
- Am I a good candidate for a bone marrow transplant?
- What do you feel is the best initial treatment for me?
- My myeloma has come back, am I a good candidate for CAR T-cell therapy?
- Would it make sense for me to receive CAR T-cell therapy sooner rather than later?
- Can you describe the process of CAR T-cell therapy?
- Does this health center offer CAR T-cell therapy? If not, where is the closest one that does?
- Do you expect me to have any negative side effects from CAR T-cell therapy?
- Can you help me understand how much I may have to pay out-of-pocket for CAR T-cell therapy?
- Are resources available to help me pay the bill?