Approved Uses

KYPROLIS® (carfilzomib) is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma... Read More

KYPROLIS® results

KYPROLIS® can help patients with relapsed or refractory multiple myeloma and has been studied in 3 clinical trials.

Understanding the results

The KYPROLIS® medication combinations were tested in 3 clinical studies. In 2 of these studies, they were compared with 2 of the standard treatments for multiple myeloma (Revlimid® + dexamethasone and Velcade® + dexamethasone). See the results for all 3 of the clinical studies below.

When patients received KYPROLIS® combinations rather than receiving 1 of the 2 standard treatments for multiple myeloma, they were able to:

  • Live longer without multiple myeloma getting worse
  • Live longer overall
  • Reach a complete response or better.

Study 1: Revlimid® + dexamethasone vs. KYPROLIS® + Revlimid® + dexamethasone*
Revlimid® + dexamethasone
KYPROLIS® + Revlimid® + dexamethasone
Patients lived without their multiple myeloma getting worse a median of
17.6 months
26.3 months
Patients lived longer overall a median of
40.4 months
48.3 months

More than 3 times as many patients reached a complete response or better when they received KYPROLIS® + Revlimid® + dexamethasone vs. Revlimid® + dexamethasone (32% vs. 9%).

Study 2: Velcade® + dexamethasone vs. KYPROLIS® + dexamethasone
Velcade® + dexamethasone twice a week
KYPROLIS® + dexamethasone twice a week
Patients lived without their multiple myeloma getting worse a median of
9.4 months
18.7 months
Patients lived longer overall a median of
40 months
47.6 months

More than 2 times as many patients reached a complete response or better when they received KYPROLIS® + dexamethasone vs. Velcade® + dexamethasone (13% vs. 6%).

Median is the middle value in a list of values arranged from low to high such that there is the same number of values above and below this middle value.

Complete response is defined as no detectable M proteins in the blood and urine, less than 5% abnormal plasma cells in bone marrow, and no detectable plasma cell tumors.

* In a clinical study of 792 patients with relapsed or refractory multiple myeloma who had failed 1-3 prior therapies, 396 patients received KYPROLIS® in combination with Revlimid® and dexamethasone, and 396 received Revlimid® in combination with dexamethasone. The study compared how long patients lived without their disease getting worse as well as how long they lived overall.

In a clinical study of 929 patients with relapsed or refractory multiple myeloma who had failed 1-3 prior therapies, 464 patients received KYPROLIS® in combination with dexamethasone, and 465 received Velcade® in combination with dexamethasone. The study compared how long patients lived without their disease getting worse as well as how long they lived overall.


Once-a-week KYPROLIS®

When patients received KYPROLIS® once a week at a
higher dose + dexamethasone,
they were able to:

Live longer without
multiple myeloma getting worse

Reach a complete response or better

Study 3: KYPROLIS® twice a week at a lower dose + dexamethasone vs. KYPROLIS® once a week at a higher dose + dexamethasone
KYPROLIS® twice a week at a lower dose + dexamethasone
KYPROLIS® once a week at a higher dose + dexamethasone
Patients lived without their multiple myeloma getting worse a median of
7.6 months
11.2 months

More than 4 times as many patients reached a complete response or better when they received KYPROLIS® once a week at a higher dose + dexamethasone vs. KYPROLIS® twice a week at a lower dose + dexamethasone (7.1% vs. 1.7%).

In a clinical study of 478 patients with relapsed and refractory multiple myeloma who had failed 2-3 prior therapies, 240 patients received KYPROLIS® at 70 mg/m2 in combination with dexamethasone once weekly, and 238 patients received KYPROLIS® at 27 mg/m2 in combination with dexamethasone twice weekly. 27 mg/m2 is not an FDA-approved dose for KYPROLIS® in combination with dexamethasone alone. The study compared how long patients lived without their disease getting worse.

Velcade® (bortezomib) is a registered trademark of Millennium Pharmaceuticals.

Revlimid® (lenalidomide) is a registered trademark of Celgene.


Real stories from real people

Hear how these patients decided to take on their multiple myeloma and start KYPROLIS®.

Yolanda's Story

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“In my case, I went into complete remission with my KYPROLIS® combination.”

Karl's Story

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“My M-protein levels stayed low, and being stable is exactly where I want to be.”

Individual results may vary

IMPORTANT SAFETY INFORMATION

KYPROLIS® (carfilzomib) can cause serious side effects:

  • Heart problems: KYPROLIS can cause heart problems or worsen pre-existing heart conditions. Death due to cardiac arrest has occurred within one day of KYPROLIS administration. Before starting KYPROLIS, you should have a full medical work-up (including blood pressure and fluid management). You should be closely monitored during treatment.
  • Kidney problems: There have been reports of sudden kidney failure in patients receiving KYPROLIS. Your kidney function should be closely monitored during treatment.
  • Tumor lysis syndrome (TLS): Cases of TLS have been reported in patients receiving KYPROLIS, including fatalities. You should be closely monitored during treatment for any signs of TLS.
  • Lung damage: Cases of lung damage have been reported in patients receiving KYPROLIS, including fatal cases.
  • Pulmonary hypertension (high blood pressure in the lungs): There have been reports of pulmonary hypertension in patients receiving KYPROLIS.
  • Lung complications: Shortness of breath was reported in patients receiving KYPROLIS. Your lung function should be closely monitored during treatment.
  • High blood pressure: Cases of high blood pressure, including fatal cases, have been reported in patients receiving KYPROLIS. Your blood pressure should be closely monitored during treatment.
  • Blood clots: There have been reports of blood clots in patients receiving KYPROLIS. If you are at high risk for blood clots, your doctor can recommend ways to lower the risk.
  • If you are using KYPROLIS in combination with dexamethasone or with lenalidomide plus dexamethasone, your doctor should assess and may prescribe another medicine to help lower your risk for blood clots.
  • If you are using birth control pills or other medical forms of birth control associated with a risk of blood clots, talk to your doctor and consider a different method of birth control during treatment with KYPROLIS in combination with dexamethasone or with lenalidomide plus dexamethasone.
  • Infusion reactions: Symptoms of infusion reactions included fever, chills, joint pain, muscle pain, facial flushing and/or swelling, vomiting, weakness, shortness of breath, low blood pressure, fainting, chest tightness, and chest pain. These symptoms can occur immediately following infusion or up to 24 hours after administration of KYPROLIS. If you experience any of these symptoms, contact your doctor immediately.
  • Severe bleeding problems: Fatal or serious cases of bleeding problems have been reported in patients receiving KYPROLIS. Your doctor should monitor your signs and symptoms of blood loss.
  • Very low platelet count: Low platelet levels can cause unusual bruising and bleeding. You should have regular blood tests to check your platelet count during treatment.
  • Liver problems: Cases of liver failure, including fatal cases, have been reported in patients receiving KYPROLIS. Your liver function should be closely monitored during treatment.
  • Blood problems: Cases of a blood disease called thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal cases, have been reported in patients who received KYPROLIS. Your doctor should monitor your signs and symptoms.
  • Brain problems: A nerve disease called Posterior Reversible Encephalopathy Syndrome (PRES), formerly called Reversible Posterior Leukoencephalopathy Syndrome (RPLS), has been reported in patients receiving KYPROLIS. It can cause seizure, headache, lack of energy, confusion, blindness, altered consciousness, and other visual and nerve disturbances, along with high blood pressure. Your doctor should monitor your signs and symptoms.
  • KYPROLIS should not be combined with melphalan and prednisone: Newly diagnosed transplant ineligible multiple myeloma patients have shown an increased risk of serious and fatal side effects when using KYPROLIS in combination with melphalan and prednisone.
  • Possible fetal harm: KYPROLIS can cause harm to a fetus (unborn baby) when given to a pregnant woman. Women should avoid becoming pregnant during treatment with KYPROLIS and for 6 months following the final dose. Men should avoid fathering a child during treatment with KYPROLIS and for 3 months following the final dose. KYPROLIS can cause harm to a fetus if used during pregnancy or if you or your partner become pregnant during treatment with KYPROLIS.
You should contact your doctor immediately if you experience any of the following:
  • Shortness of breath
  • Prolonged, unusual, or excessive bleeding
  • Yellowing of the skin and/or eyes (jaundice)
  • Headaches, confusion, seizures, or loss of sight
  • Pregnancy (women should not receive KYPROLIS if they are pregnant or breastfeeding)
  • Any other side effect that bothers you or does not go away
What are the possible side effects of KYPROLIS?
  • The most common side effects occurring in at least 20% of patients receiving KYPROLIS in the combination therapy trials are: low red blood cell count, low white blood cell count, diarrhea, difficulty breathing, tiredness (fatigue), low platelets, fever, sleeplessness (insomnia), muscle spasm, cough, upper airway (respiratory tract) infection, and decreased potassium levels.

These are not all the possible side effects of KYPROLIS. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

Please see full Product Information.

Approved Uses

  • KYPROLIS® (carfilzomib) is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. KYPROLIS is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma.

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