Millennium | Clinicians | Oncology | VELCADE

	Overview
	VELCADE^®
	Research and Development
	Clinical Trials
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	MANTLE CELL LYMPHOMA



	MECHANISM
	DISEASE BACKGROUND
	PINNACLE TRIAL DESIGN AND RESULTS
	SAFETY PROFILE
	DOSING SCHEDULE
	DOSE MODIFICATION GUIDLINES
	HANDLING AND ADMINISTRATION
	IMPORTANT SAFETY INFORMATION
	REIMBURSEMENT
	ADDITIONAL INFORMATION
	REFERENCES

PINNACLE DATA REINFORCE WELL-CHARACTERIZED, MANAGEABLE SAFETY PROFILE

THE LARGEST STUDY IN PATIENTS WITH MCL WHO HAVE RECEIVED AT LEAST ONE OR TWO PRIOR THERAPIES

The safety results observed in PINNACLE should be viewed in the context of the full product Prescribing Information, which combines data from multiple studies and identifies important safety considerations with VELCADE.

In the integrated analysis of multiple myeloma and MCL studies (N = 1163)*, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), and anemia (29%).

–	Twenty percent (20%) of patients experienced at least 1 episode of greater than or equal to Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%).

*The integrated safety analysis was conducted to evaluate the overall safety population of patients who received VELCADE dosed at 1.3 mg/m² at the same schedule in multiple myeloma and MCL trials.

Please click here to view additional important safety information.

For full Prescribing Information click here. (pdf) (74KB)

For further information about VELCADE^® (bortezomib) for Injection, call 1-866-VELCADE (U.S. clinicians only).