Kyprolis (carfilzomib) is used to treat multiple myeloma. It is for people whose multiple myeloma has relapsed (returned) or is refractory (not responding to treatment). Kyprolis is usually given in combination with other drugs, but it can also be used alone for people who have received at least one other treatment.
How Does Kyprolis Work?
Kyprolis is a type of medicine called a proteasome inhibitor. The proteasome is like the cell's "trash disposal" system. Proteasome inhibitors such as Kyprolis bind to and block the activity of the proteasome inside cancer cells. This stops the proteasomes in the cell from getting rid of extra proteins. These extra proteins then build up and kill the myeloma cell. Since cancer cells usually have more active proteasomes than normal cells, they are more easily affected by these inhibitors.
How Was Kyprolis Studied?
Kyprolis's effectiveness has been proven in several large, randomized clinical trials. Two key studies are summarized below.
The ASPIRE study
The ASPIRE study included 792 people with relapsed or refractory multiple myeloma who had received one to three previous treatments. Several groups of people were not able to take part in the study, including people who had decreased kidney function, liver problems, certain heart conditions, and those who did not respond to bortezomib or lenalidomide and dexamethasone in their most recent treatment or to any previous treatments.
People ranged in age from 31 to 91 (median, 64 years; meaning half were older and half were younger than 64). Over half of the people were male (56%), and 95% were White, 3% were Black, and 2% were reported as other or not specified.
This study compared Kyprolis in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone. Both regimens were given on a 28-day cycle (a four-week repeating schedule). Kyprolis was given for the first 18 cycles unless it was stopped early because the cancer started to get worse or people had side effects that prevented them from continuing. Lenalidomide and dexamethasone were given on the same treatment schedule in both groups. After cycle 18, people in both groups received only lenalidomide and dexamethasone. Treatment was continued until the cancer started to get worse or people had side effects that prevented them from continuing.
Dosing Schedules | |
| Kyprolis | Cycles 1 through 12
Cycles 13 through 18
|
| Lenalidomide | Days 1 through 21 |
| Dexamethasone | Days 1, 8, 15, and 22 |
The ENDEAVOR study
The ENDEAVOR study included 929 people with relapsed or refractory multiple myeloma who had received one to three previous treatments. Several groups of people were not able to take part in the study, including people who had kidney failure, certain liver problems, or heart conditions, or those who had a less than partial response to prior treatments.
People ranged in age from 30 to 89 (median, 65 years; meaning half were older and half were younger than 65). Half of the people were male (50%), and 77% were White, 2% were Black, 12% were Asian, and 9% were reported as other or not specified.
This study compared Kyprolis and dexamethasone (Kyprolis regimen) to bortezomib and dexamethasone (bortezomib regimen). The Kyprolis regimen was given on a 28-day cycle (a four-week repeating schedule). The bortezomib regimen was given on a 21-day cycle (a three-week repeating schedule). Both treatments were continued until the cancer started to get worse or people had side effects that prevented them from continuing.
Kyprolis Regimen | |
| Kyprolis | Days 1, 2, 8, 9, 15, and 16 |
| Dexamethasone | Days 1, 2, 8, 9, 15, 16, 22, and 23 |
Bortezomib Regimen | |
| Bortezomib | Days 1, 4, 8, and 11 |
| Dexamethasone | Days 1, 2, 4, 5, 8, 9, 11, and 12 |
What Benefits Were Seen With Kyprolis?
Kyprolis showed major improvements in how long people lived without their disease getting worse in both studies.
The ASPIRE study
The main goal of this study was to compare the time people lived without their cancer getting worse (progression-free survival). The time people lived without their cancer worsening (median progression-free survival) was 26.3 months for the Kyprolis group, compared to 17.6 months for the lenalidomide group. This means the risk of the cancer getting worse or death was reduced by 31% in the Kyprolis group compared to the lenalidomide group.
Other goals of the study were to see how long people lived (overall survival), the percentage of people with at least a partial response (overall response rate), and the percentage of people with at least a complete response. These results are given in the table below.
Kyprolis Group | Lenalidomide Group | |
| Median Overall Survival | 48.3 months | 40.4 months |
| Overall Response Rate | 87.1% | 66.7% |
| Complete Response (CR) or Better | 31.8% | 9.3% |
The ENDEAVOR study
The main goal of this study was also to compare the time people lived without their cancer getting worse (progression-free survival). The time people lived without their cancer worsening (median progression-free survival) was 18.7 months for the Kyprolis group, compared to 9.4 months for the bortezomib group. This means the risk of the cancer getting worse or death was decreased by 47% in the Kyprolis group compared to the bortezomib group.
Other goals of the study were to see how long people lived (overall survival), the percentage of people with at least a partial response (overall response rate), the percentage of people with at least a complete response, and the duration of response. These results are given in the table below.
Kyprolis Group | Bortezomib Group | |
| Median Overall Survival | 47.6 months | 40 months |
| Overall Response Rate | 77% | 63% |
| Complete Response (CR) or Better | 13% | 6% |
| Median Duration of Response | 21.3 months | 10.4 months |
What Are the Side Effects?
Kyprolis can cause serious side effects, including heart, kidney, liver, and lung problems. Your health care provider may need to pause or stop your treatment altogether if side effects are severe. Your health care team will monitor you closely during treatment.
Blood clots have been reported in some patients. Your health care provider may prescribe medicine to prevent blood clots, depending on how you are taking Kyprolis and your risk for blood clots. Birth control that contains estrogen can also increase the risk for blood clots. To avoid adding to this risk, you should consider a form of nonhormonal birth control during Kyprolis treatment. Talk to your health care provider if you need help choosing another form of birth control.
Serious bleeding, including bleeding that has resulted in death, has been reported. Tell your health care provider right away if you notice any signs of bleeding. This may include easy bruising, nosebleeds, discolored skin patches, and blood in your stool (poop) or urine (pee).
Kyprolis can cause vomiting and diarrhea, which can lead to dehydration. It is important to stay hydrated during treatment. Drink plenty of water. If you feel nauseous, try taking sips of water throughout the day, drinking ginger tea, reducing fatty foods, and eating smaller meals. Limit alcohol, sugary drinks, and caffeine. Eating fruits and vegetables that have a high water content (such as cucumbers and watermelon) and drinking soups or broth can also help keep you hydrated.
How Do I Take Kyprolis?
Kyprolis is given as an intravenous (IV) infusion into a vein by a health care provider. The infusion usually lasts 10-30 minutes once or twice weekly, depending on your treatment regimen.Treatment is usually continued until your cancer gets worse or you have side effects that prevent you from continuing Kyprolis.
How Can I Tell if Kyprolis Is Working?
You may not notice specific physical signs that Kyprolis is working, but your health care team will monitor key factors. They will do tests to check if the amount of myeloma protein in your blood or urine is decreasing. They may also do imaging tests (such as CT scans) to see if any tumors are shrinking or disappearing.
Is There Any Cost Assistance Available?
There is a copay savings program available from the drugmaker that can help cut your out-of-pocket cost for Kyprolis. Whether or not you are eligible depends on your insurance coverage. Call 866-264-2778 or visit www.amgensupportplus.com/Copay for more information and to apply.
