WHAT'S NEWS New F.D.A. Guidelines to Help Drug Researchers Federal health officials issued guidelines to help researchers identify sooner - with small, early tests of experimental drugs in humans - which medicines have a chance to reach the market. (from Reuters) Thalidomide makes comeback as cancer drug in Australia The drug's inclusion on the federal Government's Pharmaceutical Benefits Scheme starting February 1 for the treatment of myeloma will provide a subsidy for thousands of dollars in treatment costs. (from The Australian) European Commission Grants Orphan Drug Status for AmpliMed's Amplimexon? for the Treatment of Ovarian Cancer This is of interested to us because Amplimexon is currently in clinical trials in the UK as monotherapy for the treatment of refractory multiple myeloma. It was previously approved by the US Food and Drug Administration as an orphan drug for myeloma. (from Biotech Intelligence) Vertebroplasty Heals Fractures but May Cause Others A study finds that vertebroplasty, a procedure used to treat painful compression fractures in the spinal vertebrae, appears to increase the risk for new fractures in adjacent vertebrae. (from Newswise) If you have been thinking about attending the IMF Patient & Family Seminar in San Francisco, you need to stop thinking and start registering! We have a limited number of spaces left, and you do not want to miss it. ASH 2005: The IMF Takes You There If you were not able to attend the 47th Annual Meeting of the American Society of Hematology (ASH), you have had to make do with brief updates of the activities. Until now. The IMF brings a wide array of ASH presenters direct to you. See and hear them explain their research via our ASH 2005 webcast

WHAT'S NEW IN RESEARCH ARTICLES (IMF Scientific Advisors are marked with asterisks) Imaging techniques used in the diagnosis, staging, and follow-up of patients with myeloma. Mulligan ME Acta Radiol. 2005 Nov;46(7):716-24. Palifermin Reduces Patient-Reported Mouth and Throat Soreness and Improves Patient Functioning in the Hematopoietic Stem-Cell Transplantation Setting. Stiff PJ, Emmanouilides C, Bensinger WI*, Gentile T, Blazar B, Shea TC, Lu J, Isitt J, Cesano A, Spielberger R. J Clin Oncol. 2006 Jan 3; [Epub ahead of print] Severe pulmonary complications in Japanese patients after bortezomib treatment for refractory multiple myeloma Shigesaburo Miyakoshi, Masahiro Kami, Koichiro Yuji, Tomoko Matsumura, Masaaki Takatoku, Makoto Sasaki, Hiroto Narimatsu, Takeshi Fujii, Masateru Kawabata, Shuichi Taniguchi, Keiya Ozawa, and Kazuo Oshimi Blood published 12 January 2006, 10.1182/blood-2005-11-4541 In vivo peripheral expansion of naive CD4+CD25high FOXP3+ regulatory T cells in patients with multiple myeloma Marc Beyer, Matthias Kochanek, Thomas Giese, Elmar Endl, Martin R Weihrauch, Percy A Knolle, Sabine Classen, and Joachim L Schultze Blood published 12 January 2006, 10.1182/blood-2005-09-3671 Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple myeloma. Rifkin RM, Gregory SA, Mohrbacher A, Hussein MA*. Cancer. 2006 Jan 10; [Epub ahead of print] Infections after CD34-selected or unmanipulated autologous hematopoietic stem cell transplantation Frere P, Pereira M, Fillet G, Beguin Y. Eur J Haematol. 2006 Feb;76(2):102-8. Cataracts among cancer survivors. Stava C, Beck M, Vassilopoulou-Sellin R. Am J Clin Oncol. 2005 Dec;28(6):603-8. CLINICAL TRIALS VELCADE® trials THALOMID® trials REVLIMID® ; trials REVLIMID? Expanded Access Protocol DOXIL? trials (new sites added) A clinical trial entitled "Open-Label Phase II Study of the Safety and Efficacy of Perifosine (KRX-0401) Alone and in Combination with Dexamethasone for Patients with Relapsed/Refractory Multiple Myeloma" has been initiated at the Dana-Farber Cancer Institute in Boston, MA by principal investigator Dr. Paul Richardson. Patients with relapsed and/or refractory disease will be treated with KRX-0401 in a 150 mg daily oral dose. If a patient progresses on KRX-0401 alone, dexamethasone (20 mg twice weekly) will be added to the regimen. Dr. Rami Komrokji initiated a prospective Phase II clinical trial of the role of epidermal growth factor receptor inhibition by Cetuximab in the management of previously treated multiple myeloma at the University of Cincinnati. All stages of myeloma are eligible. Patients must have received at least one prior treatment and must have indications of disease progression. Erbitux is FDA-approved for advanced colon cancer. If you would like more information about any clinical trial, you can call the IMF Hotline at 800-452-CURE. 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 EmergingMed, with whom the IMF has entered into a partnership 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.

UPCOMING SEMINARS AND CLINICAL CONFERENCES San Francisco Patient & Family Seminar February 10-11, 2006 San Francisco, California Fort Lauderdale Patient & Family Seminar March 31 - April 1, 2006 Fort Lauderdale, Florida Portland Patient & Family Seminar July 7-8, 2006 Portland, Oregon Philadelphia Patient & Family Seminar August 4-5, 2006 Philadelphia, Pennsylvania See complete list of 2006 UPCOMING SEMINARS AND MEETINGS.

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