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consolidation & maintenance: are they needed?

The International Myeloma Foundation : Study Says Long-Term Maintenance Treatment Demonstrates 90% Overall Survival Rate
05.05.11

--U.S. Study of Continuous REVLIMID® Therapy following Transplant--

--Validates Important Treatment Option for Patients--

North Hollywood, CA and Paris, FRANCE – May 5, 2011 – The International Myeloma Foundation (IMF), the oldest and largest foundation dedicated to improving the life and care of myeloma patients, today said new data demonstrate that REVLIMID® maintenance therapy following stem cell (bone marrow) transplant delays time to disease progression and improves overall survival. The figures from the Cancer and Leukemia Group B (CALGB) study sponsored by the U.S. National Cancer Institute demonstrated a 90% overall survival rate in the REVLIMID arm of the trial at more than two years following transplant compared to 83% survival for patients given a placebo*. The study further showed that REVLIMID maintenance resulted in longer remissions, delaying disease progression by a median of four years. The findings were presented at the 13th Annual International Myeloma Workshop in Paris.

“This clearly validates an important treatment option for patients,” said Kenneth Anderson, M.D., of the Dana-Farber Cancer Institute. “The development of new, targeted drugs such as REVLIMID that are well tolerated allowed us to consider this approach, and with these new survival data we can add long-term maintenance to our arsenal as a new standard of care.”

Dr. Anderson’s patient Terry Barter entered one of the first clinical trials of REVLIMID, and he’s still taking the drug nearly ten years later: “I ride my motorcycle, I go to work every day, I have my energy, I don’t have hardly any side effects. It’s just been a great drug for me.”

A similar study of REVLIMID following transplant from the French Francophone Myeloma Intergroup (IFM) also demonstrates benefit with progression free survival, patients living longer without active disease. And maintenance is being considered as an option with other drugs including VELCADE® when administered in a reduced dose, or as a subcutaneous injection instead of the traditional I.V.

There is an issue of a small number of second cancers developing in patients taking REVLIMID long-term. Possible factors are being studied including patients’ genetic profiles and prior treatments.

“There is a risk/benefit ratio with all potent medications, but overall survival clearly demonstrates that in this case, benefit far outweighs any risk,” said Brian G.M. Durie, M.D., IMF chairman, who co-authored a retrospective analysis of REVLIMID and second cancers that was presented at the conference.

Myeloma, also called multiple myeloma, is a blood cancer that affects cells in the bone marrow and can damage bone. It cannot be cured.

Video footage and interview available on request

*(unadjusted p>0.018)

ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 195,000 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 in four key areas: research, education, support, and advocacy. To date, the IMF has conducted more than 200 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF can be reached at (800) 452-CURE. The global website is www.myeloma.org.

MEDIA CONTACTS:
United States – Jennifer Anderson +1 212 918 4642
At the conference – Stephen Gendel +1 917 856 3915

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