CLINICAL NEWS
enrolled 100 patients (median age = 62
years; range = 39-70 years) between April
2014 and February 2017. All patients
had MM that had relapsed after firstline
treatment, consisting of lenalidomide,
bortezomib, and dexamethasone (RVD)
induction and consolidation therapy,
plus lenalidomide maintenance for one
year (arm A; n=50). The other half had
undergone upfront AHCT after the
induction phase as part of the initial
protocol (arm B; n=50).
At first relapse, participants received
PCD in 28-day cycles, consisting of:
• pomalidomide 4 mg on days 1-21
• cyclophosphamide 300 mg on days 1,
8, 15, and 22
• dexamethasone 40 mg on days 1-4
and 15-18
Patients also received four re-induction
cycles with PCD. Patients in arm A who
were responding to treatment could un-
dergo AHCT and receive two additional
cycles of PCD; in arm B, patients received
five cycles of PCD. Maintenance therapy
consisted of pomalidomide plus dexa-
methasone until disease progression.
The median time from diagnosis to
first relapse was 3.6 years (range = 3.1-4.3
years), and 97 percent of patients had an
Eastern Cooperative Oncology Group
performance status score of 0 or 1. Fifteen
percent of patients had high-risk cytoge-
netics [t(4-14), del17p, and/or t(14-16)],
and most (78%) had an International Stag-
ing System score of I.
By July 4, 2017 (the planned inter-
mediate analysis data cutoff), 97 patients
had received four cycles of PCD and were
evaluable for intermediate analysis.
Eighty-two patients responded to
treatment, for an objective response
rate of 85 percent. This included one
complete remission (1%), 32 very
good PRs (33%), and 49 PRs (51%).
Three patients had stable disease (3%)
and six had progressive disease (6%).
Patients responded within a median of
28 days (range = 27-55 days).
Forty-five of 48 (94%) transplant-
naïve patients in arm A were able to
undergo planned AHCT, while seven
patients in arm B received a second
AHCT.
“The toxicity was mostly hematolog-
ic and manageable,” Dr. Garderet report-
ed. Grade 3/4 adverse events (AEs) were
reported by 72 of the 100 patients who
received the study drugs (72%), the most
common of which were hematologic
toxicities (61%, including neutropenia
[53%], lymphopenia [36%], anemia
[6%], and thrombocytopenia [5%]) and
infection (8%, including pneumonia
[63%]). No patients reported grade 3/4
peripheral neuropathy.
Six patients (6%) discontinued
one of the study drugs, and dose
reductions were required with similar
frequency for each of the three drugs
(38% of patients for pomalidomide,
35% for cyclophosphamide, and 46%
for dexamethasone). Reasons for dose
reductions included AEs/serious AEs
(77%, 70%, and 71%, respectively),
omission (13%, 13%, and 9%), and
“other” (10%, 17%, and 20%).
“The all-oral combination of PCD
was efficacious at first relapse following
RVD,” the authors reported. However,
the study is limited by its lack of a com-
parator arm and small patient popula-
tion. “These results should be com-
pared to those of other pomalidomide
and dexamethasone-based secondline
therapies,” Dr. Garderet added. ●
The authors report financial rela-
tionships with Celgene, the manufactur-
ers of pomalidomide.
REFERENCE
Garderet L, Kuhnowski F, Mary JY, et al. A multicenter open
label phase II study of pomalidomide, cyclophosphamide and
dexamethasone in relapse multiple myeloma patients initially
treated with lenalidomide, bortezomib and dexamethasone.
Abstract #837. Presented at the 2017 American Society of
Hematology Annual Meeting, December 11, 2017; Atlanta, GA.
ASH Clinical News
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