Preliminary results of a Phase 1/2 study of carfilzomib, lenalidomide, vorinostat and dexamethasone (QUAD) in relapsed and/or refractory multiple myeloma
•Dr. David Siegel, Hackensack University Medical Center, United States •Saturday, June 15, 5:45-7:00 pm CEST •Poster Session: Multiple myeloma - Translational and clinical studies 2, Poster Hall •Abstract # P774
Clinical profile of once-daily, modified-release oprozomib tablets in patients with hematologic malignancies: Results of a Phase 1b/2 trial
•Dr. Jonathan Kaufman, Winship Cancer Center, United States •Friday, June 14, 5:45-7:00 pm CEST •Poster Session: Multiple myeloma - Translational and clinical studies 1, Poster Hall •Abstract # P233
Important Indication and Safety Information Regarding Kyprolis® (carfilzomib) for Injection
Kyprolis® (carfilzomib) for Injection is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
The safety of KYPROLIS was evaluated in clinical studies of 526 patients with relapsed and/or refractory multiple myeloma.
Death due to cardiac arrest has occurred within a day of KYPROLIS administration. New onset or worsening of pre-existing congestive heart failure with decreased left ventricular function or myocardial ischemia have occurred following administration of KYPROLIS. Cardiac failure events (e.g. congestive heart failure, pulmonary edema, ejection fraction decreased) were reported in 7% of patients. Monitor for cardiac complications and manage promptly. Withhold KYPROLIS for Grade 3 or 4 cardiac events until recovery and consider whether to restart KYPROLIS based on a benefit/risk assessment. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with KYPROLIS and was Grade 3 or greater in less than 1% of patients. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for pulmonary hypertension until resolved or returned to baseline and consider whether to restart KYPROLIS based on a benefit/risk assessment.
Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported. Monitor and manage dyspnea immediately; interrupt KYPROLIS until symptoms have resolved or returned to baseline.
Infusion reactions were characterized by a spectrum of systemic symptoms, including 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 infusion or up to 24 hours after administration of KYPROLIS. Administer dexamethasone prior to KYPROLIS to reduce the incidence and severity of reactions. Inform patients of the risk and symptoms, and to contact physician if symptoms of an infusion reaction occur.
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