The International
Myeloma Foundation (IMF) – supporting research and providing education,
advocacy and support for myeloma patients, families, researchers and
physicians – today said physicians should consider lowering the dose of the
steroid dexamethasone when treating patients with multiple myeloma. High
dose dexamethasone has been used as standard therapy for the treatment of
myeloma alone and in combination with other drugs. However, interim
findings from a large ongoing clinical trial of REVLIMID(R) plus
dexamethasone in newly diagnosed patients, suggest lowering the “dex” dose
may not only reduce side effects, but also may improve survival.
The trial, known as E4A03, is sponsored by the National Cancer
Institute and led by the Eastern Cooperative Oncology Group (ECOG). Based
on these findings, ECOG has suspended further patient enrollment for this
trial and has recommended that lower dose “dex” be considered for patients
currently being treated on the high dose arm of the trial. Because of the
public health implications, these findings are being made public
immediately. The complete details will be presented at a cancer conference
later this spring.
“Improved survival with low dose ‘dex’ and REVLIMID is an important
finding because it further improves the outcome for an already successful
treatment, while low dose dexamethasone is better tolerated by patients,”
said Brian G. M. Durie, M.D., chairman and co-founder of the International
Myeloma Foundation. “We are recommending that physicians consider these
findings when treating their patients across all stages of myeloma and that
patients discuss these findings with their physicians.”
Susie Novis, president and co-founder of the IMF, added, “These
findings may also have wider implications for cancer treatments because
they challenge the traditional notion that patients should be treated with
the highest dose of medicine they can tolerate. Now we have evidence that
in some situations, less may be more when treating cancer.”
REVLIMID from the Celgene Corporation is the newest of the group of
medicines called novel therapies that have significantly improved the
outlook for patients with myeloma. Preliminary analysis of the ECOG data
shows patients taking REVLIMID plus low dose dexamethasone had a 96%
survival rate after one year with a reduced risk of side effects. One year
survival for those taking the higher dose of dexamethasone was 86%. The
findings are expected to prompt review of the dexamethasone dose when
paired with other medications used in myeloma such as THALOMID(R), and
discussions are already underway to change dosing in other clinical trials
using REVLIMID with dexamethasone.
“This is a very exciting finding for patients,” said Michael Katz, who,
as a 16-year myeloma survivor, is a vice president of the IMF and co-chair
of ECOG’s Patient Representatives Committee. “When ECOG’s patient
representatives proposed adding a lower dose ‘dex’ arm to this trial, we
were just looking for a way to make the treatment more tolerable; we never
expected that the outcome for patients would actually improve. We are
grateful to all of the patients who participated and to ECOG Group chair,
Dr. Robert Comis and Myeloma Committee chair, Dr. Vincent Rajkumar, for
supporting the notion of testing lower doses and making this trial happen.”
Mr. Katz continued: “This result sends an important signal to
physicians that maximum tolerated dose is not always the right answer when
treating patients with cancers like myeloma that are incurable, but highly
treatable.”
Myeloma, also called multiple myeloma, is a cancer of the bone marrow
that affects production of red cells, white cells and stem cells. It
affects an estimated 750,000 people worldwide, and in industrialized
countries it is being diagnosed in growing numbers and in increasingly
younger people. The REVLIMID/dexamethasone combination is approved for use
in the United States by the FDA and has been recommended for approval by
the European Medicines Agency.
ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma
organization, reaching more than 135,000 members in 113 countries
worldwide. A 501 (c) 3 non-profit organization dedicated to improving the
quality of life of myeloma patients and their families, the IMF focuses on
four key areas: research, education, support and advocacy. To date, the IMF
has conducted more than 100 educational seminars worldwide, maintains a
world-renowned hotline, and operates Bank on a Cure(R), a unique gene bank
to advance myeloma research.
International Myeloma Foundation
myeloma
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