- Celgene Receives FDA Approvable Letter for Thalomid
Despite the fact that it is not yet approved for use in myleoma, THALOMID is being used successfully "off label" by a substantial number of myeloma patients and has become an important factor in myeloma treatment. Celgene submitted a supplemental New Drug Application (sNDA) to the FDA to add multiple myeloma as an approved indication for THALOMID.
This past Friday, Celgene announced that they received an "approvable letter" from the FDA for its THALOMID multiple myeloma sNDA. The FDA letter stated that sufficient support for an accelerated approval could be provided by the results of the completed study E1A00, a large randomized Eastern Cooperative Oncology Group (ECOG) study comparing thalidomide plus dexamethasone to dexamethasone alone in previously untreated multiple myeloma patients. Celgene expects that submission of this additional data and completion of required responses and its review by the FDA could result in an accelerated approval of THALOMID as a treatment for multiple myeloma in approximately six to nine months.
Receiving an "approvable letter" means that the FDA felt that the data submitted thus far was not sufficient but that the full results of the E1A00 trial, when submitted, would likely provide the necessary support for accelerated approval.
- New! IMF "Ask the Expert" videos on current thalidomide research.
We asked the experts about thalidomide alone and in trials with various other agentsresponse, side effects, and the impact of FDA approval on its use in myeloma. Our Ask the Expert Videos are a new feature of our expanded website.
- Kosan Biosciences has been awarded orphan drug status for 17-AGG in myeloma patients.
They have initiated Phase I dose escalating trials for 17-AGG in patients with refractory or relapsed myeloma, as well as conducting trials of 17-AGG in combination with VELCADE, which could enhance its uptake. (from Comment Wire)
WHAT'S NEW IN RESEARCH
- VELCADE® trials
- THALOMID® trials
- TRISENOX trials UPDATED 10/14
- REVLIMID trials
- Randomized Phase III Study of CC-5013 plus Dexamethasone versus CC-5013 plus Low Dose Dexamethasone in Multiple Myeloma with Thalidomide plus Dexamethasone Salvage Therapy for non-Responders
Eastern Cooperative Oncology Group E4A03
Opens October 22, 2004
- Researchers will shortly be enrolling newly diagnosed myeloma patients in a randomized, multi-center, Phase III clinical trial entitled “Thal/Dex (Thalidomide and Dexamethasone) vs. Dvd-T (Doxil, Vincristine, Dexamethasone and Thalidomide) in newly diagnosed multiple myeloma patients.” Tibotec, a subsidiary of Ortho Biotech, is sponsoring the research. We will keep you posted as the sites open for enrollment.
- Prognostic and biologic significance of chromosomal imbalances assessed by
comparative genomic hybridization in multiple myeloma
Norma C. Gutierrez, Juan L. Garcia, Jesus M. Hernandez, Eva Lumbreras,
Mariana Castellanos, Ana Rasillo, Gema Mateo, Jose M. Hernandez, Sonia
Perez, Alberto Orfao, and Jesus F. San Miguel
Blood 2004;104 2661-2666
- VEGF induces Mcl-1 up-regulation and protects multiple myeloma cells
Steven Le Gouill, Klaus Podar, Martine Amiot, Teru Hideshima,
Dharminder Chauhan, Kenji Ishitsuka, Shaji Kumar, Noopur Raje, Paul G.
Richardson, Jean-Luc Harousseau, and Kenneth C. Anderson
Blood 2004;104 2886-2892
For more information, the Myeloma Matrix has a current list of all myeloma trials from pre-clinical to recently FDA approved. If you would like to browse trials currently open for enrollment, visit the Clinical Trials page of the IMF web site. Among the links, you will find CenterWatch and EmergingMed. The IMF has entered into partnerships with them to assist you in matching trials to your particular patient profile (i.e., stage of disease, previous treatment, how well you are able to carry out the activities of daily living, etc.) and by doing so, increase your chances of being eligible. You can also learn more about clinical trials by reviewing materials from the National Cancer Institute.
If you live near any these local fundraisers, why not go on over? They are always fun, and the money raised helps the IMF help others.
FUNdraising Made Easy
Suzanne Battaglia can help you plan your fundraiser, so please write, call or email (SBattaglia@myeloma.org) so that you can get on our Calendar of Events!
- Holiday Wine Vests
Just in time for the holidays, IMFer Caethe Goetz has created these adorable vests for wine bottles. A portion of each sale will be donated to the IMF.
The Multiple Myeloma Awareness Bracelet
IMFer Kristi Difford makes these beautiful custom bracelets to grace the wrists of those who have joined the struggle against Multiple Myeloma.
- Have an old cell phone lying around?
Donate your old cell phone, get a tax deduction, and become part of the cure. The IMF receives a donation for every cell phone collected. Find out how.
- The Catlett Card Series
The Catlett Cards are designed by Irma Catlett in memory of her husband Lou. All proceeds go to support the programs of the IMF.
- Volume II of Cooking with the IMF
The collection of recipes for Volume II of our very popular healthy food cookbook is being led by Marilyn Alexander, a myeloma survivor from Philadelphia. Please help us with this important project by submitting your favorite recipes.
ITEMS OF INTEREST
BE PART OF THE CURE!
Many of the internet's most popular merchants will donate a portion of your purchases to the IMF if you enter their sites using the links on our Shop For The IMF page. So, Be Part of the Cure by using these links to get the same great service and low prices you're used to while helping support the IMF!
Help Us Help Others...
As a non-profit organization, the IMF is completely dependent on the support of our members. Tax-deductible donations in honor of a friend or family member make great gifts and are a wonderful way to celebrate a special occasion. You can donate online or by calling the IMF at (800) 452-CURE. We sincerely thank you for your support.
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