Washington, Nov 22: A collaborative study has revealed that combining
the new thalidomide derivative with a steroid slows progress of
multiple myeloma, an incurable bone marrow cancer, and prolongs the
lives of patients who have relapsed from previous treatment.

In the study, 353 patients with myeloma received either a combination
of lenalidomide (Revlimid(r)) and the steroid dexamethasone or
dexamethasone plus a placebo.

"Those taking the lenalidomide combination had a median time to disease
progression of 11.1 months compared with 4.7 months in the
placebo-dexamethasone group and an improved median overall survival
time of 29.6 months compared with 20.2 months," said lead author Donna
Weber, M.D., associate professor in the Department of Lymphoma and
Myeloma at The University of Texas M. D. Anderson Cancer Center.

The results were impressive enough that in December of 2005 an
independent interim data analysis resulted in the trial being halted
early so those on placebo-dexamethasone could also benefit from the
addition of lenalidomide.

The collaborative study by North American Multiple Myeloma Study
Investigators, and an international trial led to the approval of
lenalidomide and dexamethasone for previously treated patients by the
U.S. Food and Drug Administration in 2006.

"These trials highlight how large-scale cooperation in a team effort by
myeloma investigators can quickly confirm benefits and introduce new
active agents for patients with this disease. We also owe a debt to the
willing patients who participated in this study," Weber said.

Thalidomide, a breakthrough drug for multiple myeloma, is produced and
marketed by Celgene Corporation as Thalomid. The company chemically
altered thalidomide to make lenalidomide, known commercially as
Revlimid, in hopes of reducing side effects and improving efficacy
against the disease. The drugs attack both the malignant cells and the
cellular environment that nurtures them.

Of 177 patients who received the lenalidomide combination therapy, 108
(61 percent) had complete, near-complete or partial responses to the
medication compared with 35 patients out of 176 (19.9 percent) in the
placebo-dexamethasone group.

Michael Wang, M.D., assistant professor in the Department of Lymphoma
and Myeloma at M. D. Anderson conducted an analysis and found 56.8
percent of patients who had prior treatment with thalidomide before
receiving the lenalidomide combination had a response, compared with
64.1 percent with no previous thalidomide treatment.

"That suggests that the drugs differ enough to get a separate response, not just a refinement of side effects," Weber said.

The superior results for the combination also held up among patients
previously treated with another new drug, bortezomib, a proteasome
inhibitor known commercially as Velcade and marketed by Millennium
Pharmaceuticals.

Combinations of drugs are important in ongoing treatment as a patient's disease becomes resistant to one therapy.

"It's great that this research gave us a new drug. But what we also
find with new drugs is that they work well with older therapies, which
gives us many combinations to offer our patients." Weber said.

Lenalidomide is being tested as a front-line therapy and in combination with other medications in a variety of clinical trials.

Overall, 85.3 percent of those receiving the combination therapy
experienced side effects compared with 73.1 percent of the
placebo-dexamethasone group. Some of the side effects were serious
enough to cause 19.8 percent of the combination group and 10.2 percent
of the placebo group to quit the trial.

Major side effects from the combination were suppression of patients'
white blood cells, making them vulnerable to infection, and formation
of blood clots. In most cases, these side effects were countered by
decreasing the lenalidomide dose, or administering antibiotics or
anticoagulants.

One of the major side effects of thalidomide - significant nerve pain
and numbness in the limbs known as peripheral neuropathy - was nearly
absent in the lenalidomide group.

The new study is published in the Nov. 22 New England Journal of Medicine. (ANI)