Millennium | Clinicians | Oncology | VELCADE

	Overview
	VELCADE^®
	Research and Development
	Clinical Trials
	Resources for Patients

	MULTIPLE MYELOMA



	MECHANISM
	LANDMARK PHASE 3 APEX TRIAL
	SURVIVAL
	TREATMENT TIMING
	RENAL IMPAIRMENT
	LENGTH OF THERAPY
	RETREATMENT
	SAFETY PROFILE
-	Peripheral Neuropathy
-	Transient Thrombocytopenia
	DOSE MODIFICATION GUIDELINES
	HANDLING AND ADMINISTRATION
	IMPORTANT SAFETY INFORMATION
	REIMBURSEMENT
	ADDITIONAL INFORMATION
	REFERENCES

OPTIMIZE TREATMENT

Standard 8-Cycle Dosing Schedule

	1.3 mg/m² dose VELCADE^® twice weekly (days 1, 4, 8, 11) with 10-day treatment-free period for 8 cycles
	Convenient 3-5 second bolus IV injection

Maintenance Dosing Regimen

In APEX, patients could receive up to 11 cycles of therapy (8 cycles of induction and 3 cycles of maintenance: 1.3 mg/m² on days 1, 8, 15, 22 of a 35-day cycle)

Patients responding with a CR or PR received a median of 10 cycles of VELCADE (n = 135)¹

OPTIMIZE OUTCOMES

Most Responding Patients (CR + PR) Achieved Their Maximal Serum M-Protein Reduction in Later Treatment Cycles in APEX (n=111)*¹

Most patients achieved their best response (M-protein) after longer duration of therapy (n = 111)¹

–	66% of patients had maximal M-protein reduction on or after cycle 4

29% of confirmed responding patients (CR or PR) had their first response appear on or after cycle 4 (n = 135)¹

In APEX, patients with improved quality of response (CR/nCR) had greater clinical benefits†⁶

–	Median time off treatment† was 17.5 months for CR/nCR patients versus 6.7 months for PR patients
–	Median TTP was 12.2 months for CR/nCR patients versus 8.3 months for PR patients

Please Refer to the APEX Trial Description and Dose Modification Guidelines

*A sub-analysis was performed on the 135 VELCADE patients with confirmed CR and PR according to EBMT criteria. There were 111 patients with measurable M-protein disease. A plot was drawn illustrating time to maximum M-protein reduction in this subgroup.

†In a retrospective analysis of the SUMMIT (n=202) and APEX trials (n=333) the quality of response (CR/nCR vs PR removing nCR) was correlated to clinical benefit (time to alternative therapy, overall survival, and time to progression). Time off treatment was measured from the last dose of VELCADE to the first dose of alternate therapy. Time to alternative treatment was measured from first dose of VELCADE to first dose of alternative therapy.

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).