Indications

  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
  • KYPROLIS® is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

This website is intended for healthcare professionals only

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What’s Your K.Q.?

Assess your KYPROLIS® knowledge and find out who is your iconic “spirit nurse.”

Proteasome inhibitors are recognized as an important component of multiple myeloma treatment, due to the ___________ presence of the proteasome in all myeloma cells.1,2

Correct!
Oops! The
correct
answer is B.

References: 1. Gandolfi S, Laubach JP, Hideshima T, Chauhan D, Anderson KC, Richardson PG. The proteasome and proteasome inhibitors in multiple myeloma. Cancer Metastasis Rev. 2017;36:561-584. 2. Crawford LJ, Walker B, Irvine AE. Proteasome inhibitors in cancer therapy. J Cell Commun Signal. 2011;5:101-110. 

Monitor serum
potassium levels regularly
during treatment
with KYPROLIS®.1

Correct!
Oops! The correct
answer is A.

Reference: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 

Adequate hydration is
required prior to KYPROLIS®
dosing in Cycle 1, especially in
patients at high risk
of tumor lysis
syndrome or renal toxicity. What is
the recommended hydration?1

If needed, give an additional 250 mL to
500 mL of intravenous fluids following
KYPROLIS® administration. Continue oral
and/or intravenous hydration, as needed, in
subsequent cycles. Monitor patients for
evidence of volume overload and adjust
hydration to individual patient needs,
especially in patients with or at risk for
cardiac failure.

Correct!
Oops! The
correct
answer is B.

Continue oral and/or intravenous hydration, as needed, in subsequent cycles. Monitor for volume overload and adjust hydration to individual patient needs, especially in patients with or at risk for cardiac failure.

If needed, give an additional 250 mL to 500 mL of intravenous fluids following KYPROLIS® administration.

Reference: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 

Which of the
following doses of
KYPROLIS®+dexamethasone
(Kd) is
NOT FDA
approved?1

Correct!
Oops! The correct
answer is C.
See below for additional Dosing & Administration information for KYPROLIS®.

KRd = KYPROLIS®+lenalidomide and dexamethasone; IV = intravenous.

Reference: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 

According to the National Cancer
Institute CTCAE,
adverse events
are categorized from Grade 1 to
Grade 5.

What is the correct
description of
Grade 3, 4,
and 5 adverse events?1

Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (ADL).*

Grade 4 Life-threatening consequences; urgent intervention indicated.

Grade 5 Death related to adverse event.

*Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.

Correct!
Oops!
The correct
answer is C.

Reference: 1. National Cancer Institute. CTCAE v5.0. 2017:1-146. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf. Accessed October 18, 2018. 

Fluorescence in situ
hybridization (FISH)
is
a common test that
_______________1

Correct!
Oops! The
correct
answer is A.

Reference: 1. Mikhael JR, Dingli D, Roy V, et al. Management of newly diagnosed symptomatic multiple myeloma: updated Mayo stratification of myeloma and risk-adapted therapy (mSMART) consensus guidelines 2013. Mayo Clinic Proc. 2013;88:360-376. 

The ENDEAVOR trial studied
KYPROLIS®+dexamethasone
(Kd) vs
Velcade® (bortezomib)
+dexamethasone (Vd).

What was the median
Progression-free Survival
for
Kd vs Vd in this study?1

A phase 3, randomized, open-label, multicenter superiority study compared KYPROLIS® plus dexamethasone (Kd) to Velcade® plus dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy. 929 patients were randomized to a 1:1 ratio to receive Kd (n = 464) for 28-day cycles or Vd (n = 465) for 21-day cycles until disease progression or unacceptable toxicity occurred. Patient stratification included prior proteasome inhibitor therapy (either Velcade® or KYPROLIS®, or no prior therapy), prior lines of therapy (1 vs 2 or 3), International Staging System stage (1 vs 2 or 3), and planned route of Velcade® administration, if randomized to the Velcade® group (intravenous vs subcutaneous). The primary endpoint was Progression-free Survival (PFS). Select secondary endpoints included Overall Survival (OS), overall response rate (ORR), duration of response (DoR), and safety.

ENDEAVOR = RandomizEd, OpeN label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma.

Correct!
Oops!
The correct
answer is C.

Reference: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 

As stated in the KYPROLIS®
prescribing information,
what
was the incidence rate
of Grade 2 or higher peripheral
neuropathy (PN) with
KYPROLIS®+dexamethasone (Kd)
vs Velcade® (bortezomib)+
dexamethasone (Vd)?1,2

In a phase 3, head-to-head study (Kd n = 463, Vd n = 456), PN was a prespecified secondary endpoint. The event rate of Grade 2 or higher PN in the Kd arm was 7% (95% CI: 5-9) vs 35% in the Vd arm (95% CI: 31-39).

CI = confidence interval.

Kd vs Vd study: A phase 3, randomized, open-label, multicenter superiority study compared KYPROLIS® plus dexamethasone (Kd) to Velcade® plus dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy. 929 patients were randomized to a 1:1 ratio to receive Kd (n = 464) for 28-day cycles or Vd (n = 465) for 21-day cycles until disease progression or unacceptable toxicity occurred. Patient stratification included prior proteasome inhibitor therapy (either Velcade® or KYPROLIS®, or no prior therapy), prior lines of therapy (1 vs 2 or 3), International Staging System stage (1 vs 2 or 3), and planned route of Velcade® administration, if randomized to the Velcade® group (intravenous vs subcutaneous). The primary endpoint was Progression-free Survival (PFS). Select secondary endpoints included Overall Survival (OS), overall response rate (ORR), duration of response (DoR), and safety.

Correct!
Oops!
The correct
answer is C.

References: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary.  2. Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016;17:27-38. 

The ASPIRE trial studied
KYPROLIS®+lenalidomide
and
dexamethasone (KRd) vs
lenalidomide+dexamethasone (Rd).

In the ASPIRE trial, KRd
demonstrated superior
median
Progression-free Survival vs Rd.
What were the results for each arm
in that trial?1

Correct!
Oops!
The correct
answer is C.

A phase 3, randomized, open-label, multicenter superiority study evaluated KYPROLIS® in combination with lenalidomide and dexamethasone (KRd) vs lenalidomide and dexamethasone (Rd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. 792 patients were randomized in a 1:1 ratio (396 patients to KRd, 396 to Rd). Patients received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity occurred. KYPROLIS® was discontinued after Cycle 18. The primary endpoint was Progression-free Survival (PFS); select secondary endpoints included Overall Survival (OS), overall response rate (ORR), duration of response (DoR), and safety.

ASPIRE = CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma.

Reference: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 

KYPROLIS® is the only
treatment with a
median
Overall Survival advantage
in both a
doublet (Kd56)
and triplet (KRd27)
regimen.1-3

Kd = KYPROLIS®+dexamethasone;
KRd = KYPROLIS®+lenalidomide and dexamethasone.

Correct!
Oops! The correct
answer is A.

Kd = KYPROLIS®+dexamethasone;
KRd = KYPROLIS®+lenalidomide and dexamethasone.

References: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Dimopoulos MA, Goldschmidt H, Niesvizky R, et al. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017;18:1327-1337. 3. Siegel DS, Dimopoulos MA, Ludwig H, et al. Improvement in overall survival with carfilzomib, lenalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma. J Clin Oncol. 2018;36:728-734. 

I’m inspired by

FLORENCE NIGHTINGALE

Florence Nightingale was the founder of modern nursing. In addition to establishing the first training school for nurses, she organized the nursing of sick and wounded soldiers, as well as pioneered infection-control standards. Her far-sighted ideas and reforms have influenced the very nature of modern healthcare. Florence inspires us all with her vision, compassion, and dedication.

MARY ELIZA
MAHONEY

Mary was the first African-American woman to study and work as a professionally trained nurse in the United States. She dedicated her life to helping eliminate racial discrimination in the nursing profession. In retirement, she championed women's equality and was a strong supporter of women's right to vote. Mary was inducted into the American Nurses Association Hall of Fame for her significant contributions. Mary inspires us all with her courage, intelligence, and kind heart.

CLARA
BARTON

This iconic nurse was a true pioneer who dedicated her life to helping others. From caring for wounded and dying soldiers on the front lines of battle to lecturing in support of women’s right to vote, Clara worked tirelessly to help those in need. But perhaps her greatest accomplishment is the founding of the American Red Cross.
Clara inspires all of us with her bravery, imagination, and tenacity.

Important Safety Information For KYPROLIS

Cardiac Toxicities
  • New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration.
  • Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment.
  • While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate.
  • For patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.
Acute Renal Failure
  • Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.
Tumor Lysis Syndrome
  • Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold until resolved.
Pulmonary Toxicity
  • Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug‐induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension
  • Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.
Dyspnea
  • Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.
Hypertension
  • Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.
Venous Thrombosis
  • Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks.
  • Patients using hormonal contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment.
Infusion Reactions
  • Infusion reactions, including life‐threatening reactions, have occurred. Symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms and seek immediate medical attention if they occur.
Hemorrhage
  • Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.
Thrombocytopenia
  • KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
  • Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate.
Thrombotic Microangiopathy
  • Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known.
Posterior Reversible Encephalopathy Syndrome (PRES)
  • Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known.
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients
  • In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.
Embryo-fetal Toxicity
  • KYPROLIS can cause fetal harm when administered to a pregnant woman.
  • Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months following the final dose. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Adverse Reactions
  • The most common adverse reactions in the combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia.
  • The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.
Please see full Prescribing Information.
Indications
  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
  • KYPROLIS® is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.