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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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