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

EMERGING VELCADE^® RETREATMENT DATA

VELCADE is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy.

39% Overall Response Rate (ORR) with Velcade Retreatment +/- Dexamethasone⁷

Open-label, prospective, multicenter, single-arm US study (n=28 evaluable for safety; n=23 evaluable for response)*

–	Standard VELCADE dosing†
–	68% of patients had dexamethasone
–	Median number of prior therapies: 3 (including initial VELCADE)
–	ORR defined as ≥ 50% M-protein reduction

Time from initial first dose to progression following retreatment: 32 months‡

–	Median duration of VELCADE treatment in total: 6.4 months, 2.9 months initially and 2.8 months upon retreatment
–	Median time off treatment: 11.1 months (range: 2.4-33.9 months)

VELCADE was generally well-tolerated

–	5 patients (18%) experienced new peripheral neuropathy (PN), 2 (7%) had worsening PN during retreatment
–	2 serious adverse events (SAEs) were possibly related to VELCADE: one grade 2 and one grade 3 thrombocytopenia
–	In total 11 patients reported SAEs
–	3 patients died: 2 due to disease progression, 1 due to sepsis

*The primary objective of the study was to determine ORR to VELCADE in patients who had achieved a response to prior VELCADE therapy with a duration of response > 4 months, at least 2 months of which they were off all therapy.

†VELCADE 1.3 mg/m² days 1, 4, 8, and 11 of a 21-day cycle.

‡Relapsed patients were retreated at the VELCADE dose at which they finished their initial treatment administered as a bolus injection on days 1, 4, 8, and 11 of a 21-day cycle, alone or in combination with dexamethasone at the discretion of the investigator.

31% Retreatment Response Rate in Patients with Partial Response^§ to Initial Velcade⁸

Retrospective, case series of 95 patients receiving 2 courses of VELCADE > 60 days apart in community centers

–	Median number of therapies prior to initial VELCADE: 3
–	Patients received a median of 4 cycles on initial VELCADE; 3 cycles on retreatment
–	Median time between first and second VELCADE treatment: 5 months; 45% had intervening treatment
–	54% of patients had single-agent VELCADE followed by retreatment with single-agent VELCADE

38 patients responded to initial treatment, of whom 12 (31%) responded to retreatment¶

–	Of the 24 patients who did not respond to initial treatment (less than 50% M-protein reduction), 3 (13%) responded to retreatment

Retreatment was not associated with unexpected toxicities

–

Discontinuation for toxicity decreased between initial and retreatment (from 39% to 27%)

–	Most common toxicities leading to discontinuation: neuropathy and thrombocytopenia

–

Discontinuation due to neuropathy decreased between initial and retreatment (from 17% to 5%)

§Partial response: 50%-90% reduction in M-protein values.

¶Sixty-two patients were evaluable for treatment response in both courses of therapy.

60% Overall Response Rate to Velcade^® Retreatment
in Patients Who Responsded Initially
(≥50% M-Protein Reduction)⁹

Retrospective case series designed to clarify the utility of VELCADE retreatment in academic centers (n=22)

–	Patients received at least 2 cycles of VELCADE therapy with at least a 60-day rest period prior to retreatment
–	Median number of therapies prior to retreatment: 6
–	VELCADE retreatment was typically given in combination (including dexamethasone, pegylated liposoneal doxorubicin, thalidomide, and melphalan)

Median time off treatment between end of initial VELCADE therapy and start of next alternative therapy: 12.6 months

–	Most patients (55%) had intervening treatment
–	Patients received initial treatment of 7.5 cycles of VELCADE and 5.5 cycles of retreatment
–	Patients who were sensitive to initial VELCADE treatment (≥50% M-protein reduction and TFI ≥6 months) were highly sensitive to VELCADE retreatment (75% ORR)
–	Response rates for patients who had not responded (less than 50% M-protein reduction) to VELCADE initially was 29%
–	Response rates to retreatment were similar with combination VELCADE use compared with single-agent VELCADE

No dose reductions for neuropathy upon retreatment (vs 4 during initial treatment)

–	2 patients withdrew due to toxicities during retreatment versus 3 during initial treatment
–	No hospitalizations for adverse events during retreatment (vs 3 during initial treatment)

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).