CLINICAL NEWS
Triplet Combination of Daratumumab,
Bortezomib, and Dexamethasone Improves
Multiple Myeloma Survival
Risk for VTE Changes
Throughout Myeloma
Disease Course
In the pivotal, randomized, controlled, phase III
CASTOR study, adding daratumumab to bortezomib and dexamethasone (DVd) extended progression-free survival (PFS) and time to progression
(TTP) compared with bortezomib and dexamethasone (Vd) alone in patients with relapsed/refractory
multiple myeloma (MM). Antonio Palumbo, MD,
from the University of Torino in Italy, presented the
study’s findings during the Plenary Session at the
2016 ASCO Annual Meeting.
“These results are unprecedented in this cancer,” Dr. Palumbo said during his presentation. “It’s
clear that we’ll be moving to a three-drug regimen
with daratumumab as the standard of care.”
THE CASTOR trial included 498 patients who
received ≥1 prior lines of therapy. Patients were
randomized 1:1 to receive eight cycles of:
Nearly one in three patients will experience venous thromboembolism (VTE) within the first year of a multiple myeloma (MM) diagnosis, but new research presented at the
2016 ASCO Annual Meeting found that VTE risk persists
and changes throughout the disease process.
Results from the study, led by Brea Lipe, MD, from
the University of Rochester Medical Center in New York,
also suggest that thromboprophylaxis guidelines from the
International Myeloma Working Group (IMWG) may
need to be adjusted to include VTE risk assessment and
prevention later in the disease course.
The IMWG VTE prevention guidelines categorize
patients as low- or high-risk for VTE, and recommend
aspirin for low-risk patients and low-molecular-weight
heparin (LMWH) or warfarin for high-risk patients for
the first four to six months of myeloma treatment, Dr.
Lipe and study authors explained.
“Because we understand that there is a risk of clotting,
there are guidelines to help try to minimize this risk.
These guidelines are derived from anecdotal evidence,
[and] from sub-studies of larger therapeutic trials that
look at subsets of populations pre-selected for [being]
very healthy patients,” Dr. Lipe told ASH Clinical News.
“So, the question is, ‘Does this work in the real world, and
are we doing enough?’”
The authors identified 297 patients with MM and VTE
(n=89) and 211 matched controls (patients with MM who
had not experienced VTE, matched based on gender, age,
and time of diagnosis) from the Healthcare Enterprise
Repository for Ontological Narration (HERON) database.
The median time from MM diagnosis to VTE was
952 days – years after the IMWG guidelines recommend
thromboprophylaxis. “Twenty-five percent of our patients
clotted within the first year, but then about 45 percent developed their clot after the two-year mark,” Dr. Lipe added.
Patients with a higher risk of VTE were more likely
to be prescribed LMWH or warfarin versus aspirin or no
prophylaxis (p<0.001). However, thromboprophylaxis
guidelines “are not really followed very well,” Dr. Lipe
said. “About 60 percent of patients – both in the case and
control groups – were what we would consider to be high
risk. ... But, of those 60 percent, only about 16 percent
ever received the recommended prophylactic for that
condition.” The researchers did not identify an association
between either