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Senior Citizen Health & Medicine
Drug Combination Proves Effective Against Myeloma in
Phase I Trial
Velcade and Revlimid are
relatively new drugs for multiple myeloma
December 11, 2006 – About 15,000 Americans,
primarily senior citizens, are diagnosed with multiple myeloma each
year. A new study, however, offering new hope, has found two "new
generation" drugs for the bone marrow cancer multiple myeloma may work
even better together than they do individually.
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The results of this multicenter Phase I clinical
trial are to be presented today by Dana-Farber Cancer Institute
scientists at the annual meeting of the American Society of Hematology
in Orlando, Fla.
The trial – the first and largest reported to date
to test the drugs bortezomib (Velcade) and lenalidomide (Revlimid) in
combination – involved 38 myeloma patients whose disease had recurred
after previous treatment and was progressing despite other therapies.
Participants were divided into groups that received
successively higher doses of the drugs. Some also received dexamethasone,
a standard myeloma medication which adds to the effects of both
bortezomib and lenalidomide, if the combination alone no longer
controlled their disease.
The researchers, led by Paul Richardson, MD, and
Ken Anderson, MD, of Dana-Farber, found that 58 percent of 36 evaluable
patients responded to lenalidomide and bortezomib, including six percent
who had complete remission, despite being heavily pre-treated and, in
most cases, having received both classes of drug before.
The median length of remission was six months, with
some patients having disease control for up to two and a half years.
The combined therapy also produced only mild
fatigue or peripheral neuropathy (nerve damage signaled by tingling or
numbness), researchers found.
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Read more
about multiple myeloma below this news report. |
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Patients who received dexamethasone because their
disease continued to progress on the drug combination found the
additional drug tolerable, and it produced a response or disease
stabilization in about three quarters of them.
"It is remarkable to see the combination prove both
tolerable and engender such durable responses in resistant disease,"
Richardson says. "We are hopeful that this combination will prove to be
a key therapeutic backbone in improving outcomes for our patients, both
early and later in their course."
Both Velcade and Revlimid are relatively recent
additions to doctors' arsenal against multiple myeloma. Velcade thwarts
myeloma cells by interfering with their ability to break down and
dispose of certain proteins. Revlimid also attacks the tumor cells
directly and disrupts their interactions with surrounding tissue in the
bone marrow.
The trial was based on preclinical work that found
Revlimid increases myeloma cells' vulnerability to Velcade and
dexamethasone, which suggested that patients might benefit from a
combination of them. The encouraging results of the Phase I study have
prompted investigators to begin Phase II trials of the combined therapy
in patients with newly diagnosed myeloma and in hard-to-treat, relapsed
cases. Phase III trials are also planned.
Editor's Notes:
Co-authors of the study include researchers at
Dana-Farber, St. Vincent's Comprehensive Cancer Center, New York; Beth
Israel Deaconess Medical Center, Boston; H. Lee Moffitt Cancer Center,
Tampa, Fla.; Celgene, Inc., of Summit, N.J.; and Millennium
Pharmaceuticals, Inc., of Cambridge, Mass.
The research was funded by Millennium, Celgene,
and the Jerome Lipper Multiple Myeloma Center at Dana-Farber.
Dana-Farber Cancer Institute (www.danafarber.org)
is a principal teaching affiliate of the Harvard Medical School and is
among the leading cancer research and care centers in the United States.
It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC),
designated a comprehensive cancer center by the National Cancer
Institute.
What Is Multiple Myeloma?
Multiple myeloma is
cancer that begins in
plasma cells, a type of
white blood cell. To understand multiple myeloma, it is helpful to
know about normal blood cells.
Normal Blood Cells
Most blood cells develop from cells in the
bone marrow called
stem cells. Bone marrow is the soft material in the center of most
bones.
Stem cells mature into different types of blood
cells. Each type has a special function:
White blood cells help fight
infection. There are several types of white blood cells.
Red blood cells carry oxygen to
tissues throughout the body.
Platelets help form blood clots that control bleeding.
Plasma cells are white blood cells that make
antibodies. Antibodies are part of the
immune system. They work with other parts of the immune system to
help protect the body from germs and other harmful substances. Each type
of plasma cell makes a different antibody.
Normal plasma cells help protect the body from
germs and other harmful substances.
Myeloma Cells
Myeloma, like other cancers, begins in cells.
Normally, cells grow and divide to form new cells as the body needs
them. When cells grow old, they die, and new cells take their place. In
cancer, this orderly process goes wrong. New cells form when the body
does not need them, and old cells do not die when they should. These
extra cells can form a mass of tissue called a growth or
tumor.
Myeloma begins when a plasma cell becomes
abnormal. The abnormal cell divides to make copies of itself. The
new cells divide again and again, making more and more abnormal cells.
The abnormal plasma cells are myeloma cells. Myeloma cells make
antibodies called
M proteins.
In time, myeloma cells collect in the bone
marrow. They may crowd out normal blood cells. Myeloma cells also
collect in the solid part of the bone. The disease is called "multiple
myeloma" because it affects many bones. (If myeloma cells collect in
only one bone, the single mass is called a
plasmacytoma.)
Multiple myeloma is not bone cancer. Although
multiple myeloma affects the bones, it begins in blood cells, not bone
cells.
Bone cancer is a different disease. It begins in
bone cells, not blood cells. Bone cancer is diagnosed and treated
differently from multiple myeloma.
Risk Factors
No one knows the exact causes of multiple myeloma.
Doctors can seldom explain why one person develops this disease and
another does not. However, we do know that multiple myeloma is not
contagious. You cannot "catch" it from another person.
Research has shown that people with certain risk
factors are more likely than others to develop multiple myeloma. A risk
factor is something that may increase the chance of developing a
disease.
Studies have found the following risk factors for
multiple myeloma:
● Age: Growing older increases the chance of
developing multiple myeloma. Most people with myeloma are diagnosed
after age 65. This disease is rare in people younger than 40.
● Race: The risk of multiple myeloma is highest
among African Americans and lowest among Asian Americans. The reason for
the difference between racial groups is not known.
● Personal history of monoclonal gammopathy of
undetermined significance (MGUS): MGUS is a condition in which abnormal
plasma cells make a low level of M proteins. MGUS is a benign condition,
but it increases the risk of certain cancers, including multiple myeloma.
Scientists are studying other possible risk
factors for multiple myeloma. Radiation, pesticides, hair dye, certain
viruses, obesity, and diet are under study. But it is not clear that
these factors are involved in the development of the disease.
Researchers also are studying families in which more than one person has
multiple myeloma. However, such families are extremely rare.
>>
Read more about multiple myeloma at the National Cancer Institute
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