New Clinical Trial Results Could Improve Survival While Reducing Side Effects For Many Patients
The International Myeloma Foundation researchers 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 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.