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The combination of daratumumab with bortezomib, melphalan, and prednisone (VMP)
in transplant ineligible patients with newly diagnosed multiple myeloma doubled
progression-free survival (HR 0.50), driven by more patients achieving deep responses,
including significantly higher complete response rate and tripling of the rate of negativity
for minimal residual disease, outcome of the phase III, randomized ALCYONE study shows.
M
aria-Victoria Mateos, MD, of the University
Hospital of Salamanca/Instituto de
Investigación Biomédica de Salamanca,
Spain, explained that VMP is a standard of care
for transplant-ineligible newly diagnosed multiple
myeloma.
“The first phase I/II study,” Dr. Mateos told Elsevier’s
PracticeUpdate
, “that combined bortezomib + mel-
phalan + prednisone was in Spain in 2004. Since
then, we have been working to improve on this
scheme to afford maximum patient benefit.”
“Initially,” she continued, “bortezomib was given
twice weekly, but peripheral neuropathy ensured.
So, we proceeded to administer bortezomib once
weekly. Weekly administration proved equally safe
and effective as twice-weekly administration.”
“The present study,” she explained, “completes
this experience of VMP + the monoclonal antibody
daratumumab. It has become the first randomized
phase III study of daratumumab + VMP, the stand-
ard of care, in newly diagnosed multiple myeloma.”
Daratumumab, a human immunoglobulin Gκ
anti-CD38 monoclonal antibody with a direct
on-tumor and multifaceted immunomodulatory
mechanism of action, improves progression-free
survival and depth of response significantly in com-
bination with standard of care in relapsed multiple
myeloma.
Treatment-naïve patients may benefit greatly
with the addition of daratumumab to standard of
care regimens. Dr. Mateos reported results of the
ALCYONE study, where daratumumab is added
to VMP in transplant-ineligible newly diagnosed
multiple myeloma.
Patients ≥65 years of age or otherwise ineligible
for high-dose chemotherapy with autologous stem
cell transplantation were randomized 1:1 to VMP
± daratumumab and stratified by International
Staging System I, II, or III; region (Europe vs other);
and age (<75 vs ≥75 years).
Patients were randomized 1:1 to either nine 6-week
cycles of VMP followed by observation or the same
VMP scheme + daratumumab given as continuous
therapy until disease progression:
Consistently Strong Results
Support the Addition of
Daratumumab to Therapy for
Transplant-Ineligible Newly
Diagnosed Myeloma
PRACTICEUPDATE CONFERENCE SERIES • ASH 2017
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