ASH News Daily 2017 - Issue 3 - B-20

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A Phase 3 Randomized, Controlled, Open-label
Study of Selinexor, Bortezomib, and
Dexamethasone (SVd) versus Bortezomib and
Dexamethasone (Vd) in Patients with
Relapsed or Refractory Multiple Myeloma

SVd
1:1
Randomization

selinexor, bortezomib
& dexamethasone

Progression
Free
Survival

PROGRESSIVE

bortezomib &
dexamethasone

DISEASE

SVd

& Safety

selinexor, bortezomib
& dexamethasone

Crossover for patients progressing on Vd

Phase III Study
with Crossover Design
This open-label study will compare the eﬃcacy
and assess the safety of oral selinexor
plus bortezomib (Velcade® once weekly) plus
low-dose dexamethasone (SVd) versus
bortezomib (twice weekly) plus low-dose
dexamethasone (Vd) in patients with Relapsed
or Refractory Multiple Myeloma
* Global trial enrolling ~360 patients with
1-3 prior lines of anti-myeloma therapy
* Both bortezomib-exposed and
bortezomib-naïve patients allowed
* SVd Arm: once weekly injection of
bortezomib for 4 out of 5 weeks
* Vd Arm: twice weekly bortezomib injection
2 out of 3 weeks x 8 cycles, then once
weekly 4 out of 5 weeks
* For Vd arm, crossover to SVd permitted
once progression is conﬁrmed

Selinexor is an investigational agent, and safety and
eﬃcacy have not been established by any agency
VELCADE is a registered trademark of Millennium Pharmaceuticals, Inc.

To learn more visit www.clinicaltrials.gov

of hematology, Dr. Laurence Hartford, who dealt with platelet problems and told him, "I want to work
with you to solve issues around
platelet support in thrombocytopenic issues." She realized that they
first had to understand the cause
of the issue to then fix it; thus, Dr.
Slichter devoted a 45-year career to
revolutionizing platelet transfusion
therapy. She has identified methods
to significantly prolong shelf life of
platelets, determined approaches to
prevent alloimmune platelet refractoriness, identified the minimum
number of platelets required to
maintain hemostasis, and provided
insights into understanding platelet
production and viability.
Of Dr. Slichter's many accomplishments, she is most proud of
an important breakthrough in preventing immunization of platelets
that will make platelet products
available for all patients without the
necessity of matching donors and
recipients. Through the use of dog
models, she and her colleagues were
able to develop methods of modifying the platelets prior to transfusion,
in order to prevent platelets from being recognized as foreign by a transfused recipient and subsequently rejected. "I am most proud that after 35
years, at least in our dog model, we
have determined how to prevent immunization to donor platelets, and
that it is the white cells that really
contaminate platelet transfusions."
Dr. Slichter also expressed excitement about new breakthroughs including inactivating bacteria viruses
within blood products, which can
help prevent another epidemic, such
as AIDS, that can be transmitted by
transfusion.
Simultaneously, Dr. Slichter discussed her work on new platelet
products, freezing platelets for storage, and freeze-drying platelets, all
to increase the efficiency of platelet
transfusions for trauma and surgical patients. This has been an issue
because of the limited shelf life of
platelets. "With a five-day shelf life,
for example, the military asked me
to go back to [Washington,] DC because they didn't have platelets for
soldiers," she explained. "With such
a short shelf life, they couldn't get
them to patients in Afghanistan. Red
cells you can store for 42 days, plasma for years, but platelets just for
five days." She thus called for support for breakthroughs in this area
as the process to license the method
of pathogen reduction to increase
the shelf life of platelets has yet to be
approved in the United States by the
U.S. Food and Drug Administration
because of its very high costs.
Similar to most recipients, Dr.

"I am most proud that
after 35 years, at least in
our dog model, we have
determined how to
prevent immunization to
donor platelets, and that
it is the white cells that
really contaminate
platelet transfusions."
- Dr. Slichter

Slichter was surprised to receive the
award. "I think I may be the first
person who achieved this award
for work in transfusion medicine,
and it is very unusual that women
receive these kinds of awards," she
saids. In order to be allowed to take
physics, chemistry, math, and other
male-dominated subjects, Dr. Slichter's parents had to give signed
permission. She learned quickly
that nothing would be handed to
her, and determined to work hard
to make progress, believing in herself, and never taking "no" for an
answer. Aside from that formula for
success, Dr. Slichter remembered
having great mentors along the way.
She worked closely with Dr. Laurie
Harper, Dr. E. Donnall Thomas, who
won a Nobel Prize for establishing
bone marrow transplantation, and
Dr. Clement Finch, who constantly
helped her think through the data
and determine the next steps to answer an important question. The
best advice she received was to
work hard, stay focused, and really
consider the data. She advised those
coming into the field to "find a problem that interests you and then stick
with it; find mentors and colleagues
to work with. One person doesn't
solve all of the issues by themselves,
so don't be afraid to share your
thoughts with your colleagues."
In a profession that relies so heavily on collaboration, Dr. Slichter
cautioned newer professionals that
there is no room for selfishness.
"Don't be afraid someone will take
your idea; that's not how science
works. Science works by being collegial and discussing with colleagues.
You are working for your patients."
Josef T. Prchal, MD
Dr. Prchal is professor of medicine in hematology, pathology, and
genetics at the University of Utah in
Salt Lake City. He has devoted a 40year career to the study of a broad
range of red cell disorders. Dr. Prchal's decision to focus on hematology as a specialty stemmed from
the fact that it would allow him to
explore disease phenotypes better than in other fields because of
easy access to blood, established
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Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 3