Pharmacy and Therapeutics - January 2008 - (Page 47) In Multiple Myeloma Turn to VELCADE With DOXIL For a Statistically Significant Increase in Time to Progression vs VELCADE Alone VELCADE 6.5 Months Median TTP a (95% CI: 5.6, 7.1) (n=322) VELCADE + DOXIL 9.3 Months Median TTP a (95% CI: 8.2, 11.1) (n=324) *DOXIL in combination with VELCADE® (bortezomib) is indicated for the treatment of patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy. Study Design 100 Percentage of Patients Progression-Free 90 80 70 60 50 40 30 20 10 0 6.5 N=646 P<.0001b HR=0.55 c 95% CI 0.43 to 0.71 A 43% increase in median TTP when DOXIL was combined with VELCADE— a statistically significant increase (P<.0001) VELCADE (n=322) VELCADE + DOXIL (n=324) 9.3 0 Number of Subjects at Risk 4 8 12 15 TTP (Months) 301 290 269 253 201 189 170 150 127 112 97 84 70 56 56 35 38 25 19 14 13 9 6 2 4 1 2 1 0 0 VELCADE + DOXIL 324 VELCADE 322 Randomized, open-label, international, multicenter study (N=646) of patients with multiple myeloma who had not previously received VELCADE and whose disease progressed during or after at least 1 prior therapy. The primary endpoint was time to progression (TTP). Patients were randomized (1:1 ratio) to receive either DOXIL (30 mg/m2 as a 1-hour IV infusion) administered on Day 4 following VELCADE (1.3 mg/m2 IV bolus on Days 1, 4, 8, and 11) or VELCADE alone (1.3 mg/m2 IV bolus on Days 1, 4, 8, and 11). Treatment was administered every 3 weeks. Patients were treated for up to 8 cycles until disease progression or the occurrence of unacceptable toxicity. Patients who maintained a response were allowed to receive further treatment. The median number of cycles in each treatment arm was 5 (range, 1–18). Please see Important Safety Information, including Boxed WARNINGS, on previous page.
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