APEX Trial - Most Common Side Effects
Side Effect Velcade
Percentage of Patients
(N=331)
Dexamethasone
Percentage of Patients
(N=332)
Asthenic conditions (fatigue, malaise, weakness)
61%
45%
Diarrhea
57%
21%
Nausea
57%
14%
Constipation
42%
15%
Peripheral neuropathy*
36%
9%
Vomiting
35%
6%
Fever
35%
16%
Thrombocytopenia
35%
11%
Psychiatric disorders
35%
49%
Decreased appetite or weight loss
34%
9%
Tingling sensation and impairment of sensitivity
27%
11%
Anemia
26%
22%
Headache
26%
13%
Cough
21%
11%
*Represents treatment emergent neuropathy
Recommended Dose Modifications for Velcade-related Neuropathic Pain and/or Peripheral Sensory or Motor Neuropathy
Severity of Peripheral Neuropathy Signs and Symptoms Modification of Dose and Regimen
Grade 1* (paresthesias [sensations of numbness, tingling, or prickling], weakness, and/or loss of reflexes) without pain or loss of function
No action
Grade 1 with pain or Grade 2 (interfering with function but not with activities of daily living)
Reduce Velcade dose to 1.0 mg/m²
Grade 2 with pain or Grade 3 (interfering with activities of daily living)
Withhold Velcade therapy until toxicity resolves. When toxicity resolves, reinitiate with a reduced dose of Velcade at 0.7 mg/m² and change treatment schedule to once per week.
Grade 4 (permanent sensory loss that interferes with function, sensory neuropathy which is disabling, or motor neuropathy that is life threatening or leads to paralysis)
Discontinue Velcade
*The grades of severity listed here relate specifically to neuropathy