Trial Information

A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

This is a randomized (study drug assigned by chance), parallel-group, open-label (all
involved people know the identity of the intervention), multicenter study in 18 countries. A
total of 646 patients with multiple myeloma whose disease has progressed after an initial
response to at least 1 line of prior therapy or was refractory to initial treatment will be
enrolled. The primary endpoint is time to progression (the interval between the date of
randomization and the date of disease progression); secondary endpoints are overall survival
(the interval between the date of randomization and the patient's death from any cause),
response rate (the proportion of patients in the evaluable population who achieved a
complete or partial response), and safety. Other study endpoints include patient reported
outcomes and exploratory pharmacogenics (to identify genetic markers of response). Patients
are assessed for efficacy and safety every 3 weeks until disease progression is documented
or for up to 42 weeks from the start of the first dose of study drug. Patients, who do not
progress after the 42-week period, are assessed every 6 weeks until disease progression is
documented. Efficacy evaluations includes: serum protein electrophoresis, 24-hour urine
collection for protein electrophoresis, skeletal survey (plain films), bone marrow biopsy
and aspirate, clinical or radiologic assessment of plasmacytomas, and serum calcium.
Responses and progressions are assessed objectively by a computer algorithm based on the
EBMT criteria. Safety evaluations include adverse event reports, changes in clinical
laboratory findings, and tests for cardiac function (multiple gated acquisition
scan/echocardiogram and electrocardiogram). Group A: VELCADE monotherapy: VELCADE 1.3 mg/m2
to be administered by i.v. bolus on Days 1, 4, 8, and 11 of each 21-day cycle. Group B:
DOXIL/VELCADE combination: treated with VELCADE at the same dose and schedule as specified
in Group A. DOXIL/CAELYX 30 mg/m2 by intravenous infusion given on Day 4 of every 21-day
cycle following the administration of VELCADE.