Written in Blood
STRATUS MM-010 Trial: Pomalidomide Plus
Low-Dose Dexamethasone in Relapsed/Refractory
Multiple Myeloma
There is an unmet need for relapsed/
refractory multiple myeloma (MM)
patients who have failed treatment with
newer agents (e.g., lenalidomide and
bortezomib), as overall survival (OS) is
decreased in this population. In the
pivotal phase II MM-002 and phase
III MM-003 clinical trials, the combination of pomalidomide and lowdose dexamethasone was shown to
improve response and survival rates
compared with pomalidomide alone
and with high-dose dexamethasone,
respectively, among patients with
relapsed/refractory MM.
To further assess the safety
and efficacy of pomalidomide plus
low-dose dexamethasone, Meletios
A. Dimopoulos, MD, from the
National and Kapodistrian University of Athens School of Medicine in
Greece, and investigators conducted
the open-label, single-arm, phase
IIIb STRATUS MM-010 trial.
According to results published in
Blood, Dr. Dimopoulos and coauthors confirmed the benefit of
pomalidomide plus low-dose dexamethasone, with an overall response
rate (ORR; the study’s primary
endpoint) of 32.6 percent (95% CI
29-36.2) and a median duration of
response (DOR; one of the study’s
secondary endpoints) of 7.4 months
(95% CI 4.2-5.6).
MM-010 STRATUS included
682 patients with relapsed/refractory
MM enrolled at 91 centers in 19 European countries between November
2012 and December 2014.
Adult patients were considered
for inclusion if they:
• had received ≥2 previous lines
of treatment, including ≥2 cycles
of lenalidomide and bortezomib
(alone or in combination) and
adequate prior alkylator therapy
(≥4 cycles or progressive disease
[PD] after ≥2 cycles or received
alkylator treatment as a part of a
stem cell transplant)
• had failed treatment with both
bortezomib and lenalidomide
(defined as PD on or within 60
days of treatment, PD ≤6 months
after achieving a partial response,
or intolerance to bortezomib)
Patients were excluded if they had
received a hematopoietic cell transplant or if they were planning for or
eligible for transplant.
The median patient age was
28
ASH Clinical News
66 years, and median time since initial
diagnosis was 5.3 years. Patients had been
treated with a median of five prior antimyeloma treatment regimens (range =
2-18 treatments).
Patients received pomalidomide 4
mg on days one through 21 of a 28-day
cycle and low-dose dexamethasone 40
mg (if ≤75 years) or 20 mg (if >75 years)
on days one, eight, 15, and 22 of a 28-day
cycle. Patients who discontinued treatment were followed every three months
for up to five years after enrollment to
monitor subsequent treatments, dates
of progression, survival, and second
primary malignancies (SPMs).
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The study’s primary safety endpoint
was the incidence of adverse events (AEs;
type, frequency, severity, and relationship
to drug), including SPMs. Secondary endpoints included pomalidomide exposure,
ORR, DOR, progression-free survival
(PFS), overall OS, time to response, and
time to progression.
After a median follow-up of 16.8
months, 15.2 percent of patients (n=104)
remained on treatment and 83.9 percent
BOSULIF is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia
chromosome–positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
In the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy
Everyone has a distinct profile
Consider your patient.Consider BOSULIF.
( b o s u t inib)
Bosutinib (BOSULIF®) is recommended by the NCCN Clinical Practice Guidelines in
Oncology (NCCN Guidelines®) as a treatment option for patients with CML in need
of 2nd- or later-line TKI therapy.1
Study design: BOSULIF 500 mg once-daily treatment was studied in a single-arm, Phase 1/2, open-label, multicenter
trial (N=546) in patients with CP, AP, or BP CML in second line (after imatinib) or in third line (after imatinib followed by
dasatinib and/or nilotinib). Of the 546 patients enrolled, 73% were imatinib resistant and 27% were imatinib intolerant.2
AP=accelerated phase; BP=blast phase; CP=chronic phase.
IMPORTANT SAFETY INFORMATION
Contraindication: History of hypersensitivity to BOSULIF. Reactions have
included anaphylaxis. Anaphylactic shock occurred in less than 0.2% of treated
patients in clinical trials.
Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain
can occur. In the clinical trial, median time to onset for diarrhea was 2 days,
median duration was 1 day, and median number of episodes per patient was 3
(range 1-221). Monitor and manage patients using standards of care, including
antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce,
or discontinue BOSULIF as necessary.
Myelosuppression: Thrombocytopenia, anemia, and neutropenia can occur.
Perform complete blood counts weekly for the first month and then monthly
or as clinically indicated. Withhold, dose reduce, or discontinue BOSULIF
as necessary.
Hepatic Toxicity: Twenty percent of patients experienced an increase in either
ALT or AST. Liver en zyme elevation usually occurs early in treatment. Perform
hepatic enzyme tests monthly for the first 3 months and as clinically indicated.
In patients with transaminase elevations, monitor liver enzymes more
frequently. Drug-induced liver injury has occurred. Withhold, dose reduce, or
discontinue BOSULIF as necessary. In patients with mild, moderate, or severe
hepatic impairment, the recommended starting dose is 200 mg daily.
Renal Toxicity: An on-treatment decline in estimated glomerular filtration
rate has occurred in patients treated with BOSULIF. Monitor renal function
at baseline and during therapy, with particular attention to patients with
preexisting renal impairment or risk factors. Consider dose adjustment
in patients with baseline and treatment emergent renal impairment. The
recommended starting doses for patients with severe renal impairment
(CrCL <30 mL/min) or moderate renal impairment (CrCL 30-50 mL/min)
are 300 mg and 400 mg daily, respectively.
Fluid Retention: Fluid retention can occur and may cause pericardial effusion,
pleural effusion, pulmonary edema, and/or peripheral edema. Monitor
and manage patients using standards of care. Interrupt, dose reduce, or
discontinue BOSULIF as necessary.
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