Melphalan and prednisone plus bortezomib may improve
time to progression in patients with newly diagnosed multiple myeloma.
According to researchers from the Hospital
Universitario Salamanca in Spain and various sites across Europe, adding
bortezomib (Velcade, Millennium Pharmaceuticals Inc.) to combination melphalan
(Alkeran, GlaxoSmithKline) and prednisone is superior to melphalan plus
prednisone alone in newly diagnosed patients who are not eligible for high-dose
therapy.
The researchers randomly assigned 682 patients to nine
six-week cycles of melphalan plus prednisone on days one to four or to the same
combination plus bortezomib on days one, four, eight, 11, 22, 25, 29 and 32
during the first through fourth cycles and on days one, eight, 22 and 29 during
the fifth through ninth cycles.
Time to progression was 24 months in the combination
plus bortezomib group, compared with 16.6 months in the combination alone group
(P<.001).
A larger proportion of patients in the bortezomib group
had a partial response or better (71%), compared with the combination alone
group (35%). The rates for complete response were also superior in the
bortezomib group, compared with combination alone (30% vs. 4%;
P<.001).
The researchers reported a longer response time in the
bortezomib group, compared with combination alone (19.9 months vs. 13.1
months).
More patients in the bortezomib group experienced
grade-3 events (53% vs. 44%; P=.02), but the rate of grade-4 events and
treatment-related deaths were similar in both groups.
N Engl J Med. 2008;359:906-917.