- KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. ... Read More
DKd vs Kd safety
DKd led to longer time on therapy and had comparable discontinuation rates vs Kd1
Median treatment duration of KYPROLIS®1
Permanent discontinuation of KYPROLIS® due to ARs1
Safety experience with DKd vs Kd1
- Fatal adverse reactions within 30 days of the last dose of any study treatment occurred in 10% of 308 patients in the DKd arm compared with 5% of 153 patients in the Kd arm1
- The most frequent fatal adverse reaction that occurred in patients in the 2 arms (DKd vs Kd) was infections (4.5% vs 2.6%)1
- Dose reduction of KYPROLIS® due to adverse reactions occurred in 25% of patients in the DKd arm vs 20% in the Kd arm1
DKd = KYPROLIS®+Darzalex® (daratumumab) and dexamethasone; Kd = KYPROLIS®+dexamethasone; ARs = adverse reactions.
Adverse reactions (≥ 15%) in patients who received either DKd or Kd1
(n = 308)
(n = 153)
|All grades||Grade 3 or Grade 4||All grades||Grade 3 or Grade 4|
|General disorders and administration site conditions|
|Respiratory tract infectionc||40%g||7%||29%||3.3%|
|Blood and lymphatic system disorders|
|Respiratory, thoracic, and mediastinal disorders|
|Musculoskeletal and connective tissue disorders|
aThe incidence of infusion‐related reactions is based on a group of symptoms (including hypertension, pyrexia, rash, myalgia, hypotension, blood pressure increased, urticaria, acute kidney injury, bronchospasm, face edema, hypersensitivity, rash, syncope, wheezing, eye pruritus, eyelid edema, renal failure, swelling face) related to infusion reactions which occurred within 1 day after DKd or Kd administration.
bFatigue includes fatigue and asthenia.
cRespiratory tract infection includes respiratory tract infection, lower respiratory tract infection, upper respiratory tract infection, and viral upper respiratory tract infection.
dThrombocytopenia includes platelet count decreased and thrombocytopenia.
eAnemia includes anemia, hematocrit decreased, and hemoglobin decreased.
fCough includes productive cough and cough.
gIncludes fatal adverse reactions.
At a median follow-up of nearly 17 months: DKd had comparable exposure-adjusted risks of adverse reactions vs Kd2,3
Exposure-adjusted adverse reactions2,3
|Category||DKd (n = 308)
EARE* (95% CI)
|Kd (n = 153)
EARE* (95% CI)
|Grade 3 or higher||195.8 (173.1-221.5)||172.5 (143.4-207.4)|
|Serious||75.9 (65.4-88.1)||73.4 (58.0-92.7)|
|Fatal||9.1 (6.4-13.0)||6.2 (3.1-12.4)|
*Per 100 subject years.
EARE = exposure-adjusted risk estimate.
DKd vs Kd study design: Phase 3, randomized, open-label, multicenter trial that compared KYPROLIS® plus daratumumab and dexamethasone (DKd) to KYPROLIS® plus dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. 466 patients were randomized 2:1 to receive DKd (n = 312) or Kd (n = 154) twice weekly for 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was PFS. Select secondary endpoints included ORR, MRD-negative CR rate at 12 months, OS, and safety.1,2
PFS = progression-free survival; ORR = overall response rate; MRD = minimal residual disease; CR = complete response; OS = overall survival.