What's News

• Well wishers from around the world converged on sunny Rochester, Minnesota the first weekend of August to join the IMF?in presenting its first Robert A. Kyle lifetime achievement award to the man in whose honor it is named. See more pictures and read about the event.
  
  
  
• International Non-Profit Decorates Pacific Northwestern Medical Community with Annual Ribbon of Hope
  The International Myeloma Foundation celebrates 13 years of continuing service and support to the multiple myeloma community with their annual Anniversary Gala Ribbon of Hope - Making a World of Difference. Hosted in beautiful Seattle for the first time, this major annual fundraising event will take place on October 4, 2003 at the Experience Music Project (EMP) at the Seattle Center in Washington.(from BusinessWire)
  
  
• Advocates Needed to Contact Congress to Increase Medical Research Funding
  This is technically an Advocacy Update, but it is so important, we put it here as well to make sure you see it.
  
  
• ASCO's People Living with Cancer Profiles IMF President Susie Novis
  "Cancer has changed my life in that my whole life is wrapped up in cancer, not only at an emotional level, but at a professional level as well. It is the driving purpose behind what I do, particularly when at the end of the day, you can look at yourself in the mirror and you can say, 'I made a difference today; I made someone's life better.'"
  
  
• IMF Japan Petitions The Ministry Of Labor & Welfare for Approval of Thalidomide and Velcade
  On July 9th, IMF Japan presented its appeal on behalf of myeloma patients in Japan.
  
  
• Medicare bill may threaten cancer treatment
  LaWanna Jones just wants to be left alone. For 10 years, the 78-year-old has waged a tiring but stubborn war against multiple myeloma. Now she is frightened by television reports warning her that cancer doctors soon may not be able to care for their Medicare patients -- that a new bill in Congress might somehow drive them to shut their doors.
  (from Atlanta Business Chronicle)
  
  
• Don't Get Killed By Bills
  A confusing medical bill. Is there any other kind? Healthcare financial systems are set with medical providers and insurance companies in mind, not patients. (from US News)
  
  
• 8.7 million awarded in the second round of Cancer Research Fund grants to 19 top Ontario researchers
  The grants are administered by the Ontario Cancer Research Network (OCRN), a non-profit organization established by a $100-million investment from the Ontario government. The OCRN provides grants to researchers conducting laboratory and clinical research and testing needed to transform promising discoveries into new treatments that can prevent, diagnose, control and ultimately cure various forms of cancer. (from Canada Newswire)
  
  

Q. Is Zometa safe for myeloma patients? Should I switch to Aredia? There has been an article circulating on the myeloma list serve about a number of myeloma patients who had kidney failure as a result of taking Zometa.

A. Aredia (pamidronate) and Zometa (zoledronate or zoledronic acid) are the two drugs currently approved by the Food and Drug Administration for use in preventing bone disease in multiple myeloma. They belong to a class of drugs called "bisphosphonates." Aredia was approved in 1996 and became the standard of care for myeloma patients. It has become established as a very safe, helpful drug for the treatment of myeloma bone disease. Zometa was approved in early 2002 based upon study results comparing it with Aredia. Zometa produces more rapid and prolonged reduction in elevated blood calcium when elevated levels are present. However, results evaluating the effects on skeletal related events ("SREs"--tumors and holes in the bone) showed that Zometa and Aredia affect SRE's equivalently. The major difference with Zometa, therefore, proved to be its much shorter infusion time of 15 minutes versus 2 to 4 hours for Aredia.

The most common side effects of either drug are fever, vein irritation at the site of the infusion, general aches and pains, and kidney dysfunction. Fever associated with bisphosphonates is typically mild (i.e. 100 degrees to 101 degrees), occurring a few hours after intravenous infusion and lasting for a few hours at most. Fever is usually easily treated or prevented with 1 or 2 Tylenol (325 mg per tablet).

The main additional concern relates to kidney side effects. All bisphosphonates are potential toxins for the kidneys. Since myeloma can have an impact on kidney function (due to myeloma protein damage or elevated blood calcium), the possibility of kidney-related side effects is of particular concern. Aredia has been used widely for almost 10 years, including the initial trials period. The main toxicity that has emerged is a type of protein loss in the urine (albuminuria or nephrotic syndrome). This toxicity has occurred predominantly with uses of higher than recommended doses (e.g. 180 mg versus 90 mg) and/or more frequent than recommended dosing schedules (e.g. every two weeks instead of once a month). This side effect is usually reversible with dose and/or schedule adjustments or, in occasional severe cases, discontinuing Aredia. Very rare irreversible damage has occurred. Periodic monitoring (e.g. every 3 to 6 months) of urine protein levels with 24-hour urine collection is recommended to prevent any significant kidney damage from Aredia.

Zometa, on the other hand, has only been in clinical use for 18 months. The major toxicity-related concern that has emerged with Zometa is an increase in serum creatinine, which is an indication of kidney dysfunction. Reports of both increased creatinine and occasionally more severe kidney damage, acute tubular necrosis, within the first year have raised concerns that this much more potent bisphosphonate must be used more cautiously with respect to kidney function.

The article which is being referred to on the list serve was published in Kidney Int. 2003 Jul; 64(1): 281-289, entitled "Toxic acute tubular necrosis following treatment with zoledronate (Zometa)." The authors, from the departments of pathology, nephrology, and internal medicine at Columbia Presbyterian Hospital in New York, Morristown Memorial Hospital in New Jersey, and Community Medical Center in East Toms River, New Jersey, evaluated six patients who had kidney failure after receiving Zometa (five of them diagnosed with myeloma, the sixth with Paget's Disease of the bone). All six of the patients had bone disease, and all received pamidronate (Aredia) before being switched to Zometa. Of note: none of the six patients had previous evidence of kidney disease. The mean duration of Zometa therapy for these patients was 4.7 months before renal failure occurred. All had received the correct, recommended dose: 4 mg of Zometa once a month, infused over at least 15 minutes.

In addition, three abstracts presented at the most recent ASCO (American Society of Clinical Oncology) meetings in Chicago, raised concerns about kidney toxicity with Zometa and, as in the above article, particularly in patients switching from Aredia to Zometa.

As a result of similar reports from around the country, Novartis, the company that makes both Aredia and Zometa, has proposed a set of guidelines for physicians who treat myeloma patients. These guidelines include the following precautions:

• Be especially cautious with the use of Zometa if there is concern from the outset for kidney dysfunction?i.e. with Bence Jones myeloma, diabetes, long-standing high blood pressure, or in elderly or frail patients. Do not use Zometa in patients with known kidney deterioration, especially if the creatinine value is over 3 mg/dl.
  
  
• Check the serum creatinine level before each dose of Zometa.
  
  
• If the serum creatinine value has increased by > (greater than or equal to) 0.5 mg/dl in a patient with normal renal function at the outset, the doctor should hold the next dose until the value returns to within 10% of baseline.
  
  
• For those patients who have experienced mild elevations in serum creatinine values that have returned to 10% of baseline, adjustments to the treatment schedule may be considered, to include increasing the time of infusion from 15 minutes to 30 or 45 minutes, using larger volumes of diluting fluids, or delaying the administration of the next dose. The treating physician should use his/her clinical judgment to determine which option is the most appropriate for an individual patient.
  
  
• Certain drugs that may affect kidney function could be more likely to do so if they are given concurrently with bisphosphonates. Some examples of these medications may include nonsteroidal anti-inflammatories (NSAIDs), thalidomide, and certain antibiotics.

In order to avoid an infusion rate that is more rapid than planned or anticipated, an infusion time of 30 minutes can be strongly considered. Using a 30 minute infusion time provides some leeway for the infusion center and can help prevent Zometa from ever being infused in less than 15 minutes.

With the above caveats in mind, you should be scrupulous in discussing with your doctor whether or not Zometa is an appropriate choice for you, and in turn, your doctor should be scrupulous in monitoring your serum creatinine level before your monthly infusion of bisphosphonates.

What's New in Research:

Newly Identified Tumor Suppressor Cooperates With p53 to Protect Mice Against Tumors
In a study published in the Aug. 8, 2003, issue of the journal Cell, researchers at the National Cancer Institute demonstrate that reducing or eliminating the H2AX gene in mice that lack p53, a well-known tumor suppressor gene, causes an increase in the number of tumors that develop.

• Maintenance with pamidronate following first-line MP or VAD therapy in multiple myeloma.
  Kondo H, Mori A, Kubota M.
  Despite small numbers, the results suggest that pamidronate may have anti-tumor activity and be useful for treatment after the conventional chemotherapy in some cases of MM.
  
  
• Mayo Clinic researchers report that gene therapy makes multiple myeloma cells more sensitive to radiotherapy.
  Transduction of myeloma cells with the targeted vector coding for hNIS led to its expression by these cells allowing them to concentrate radioiodine up to 18-fold compared with controls.
  
  
• Apomine has demonstrated potential bone-building activity in preclinical studies
  Like the more well-known bisphosphonic acids such as Fosamax? (alendronate) and Actonel? (risedronate), Apomine has been shown in preclinical models to inhibit osteoclasts and bone metastasis. However, unlike the bisphosphonic acids, it appears to also have antitumor activity and to activate osteoblasts, with potential anabolic (bone-building) effects. (from ILEX's press release)

• New Phase III thalidomide study taking place at Mayo Clinic, Rochester, MN, and its Arizona and Florida satellites:
  Randomized trial of thalidomide plus zoledronic acid versus zoledronic acid alone in patients with early stage multiple myeloma. Contact: VIncent Rajkumar, MD 507-284-8430.
  
  
• New sites added to Open Label Multicenter Phase II REVIMID trial as of 08/11/03
  
  
• New sites added to Phase III?THALOMID study list as of 08/06/03
  
  
• New sites added to Phase III VELCADE study list as of 7/25/03
  
  
• New sites added to Phase III REVIMID study list as of 08/11/03
  
  
• New site added to Phase II Trial of VELCADE Alone and in Combination with Dexamethasone in Previously Untreated Multiple Myeloma Patients as of 08/17/03
  
  
• Phase I Trial of VELCADE and Melphalan. A prospective, open-label, safety and efficacy study of combination treatment with VELCADE and melphalan in patients with relapsed or refractory multiple myeloma. Investigator: James Berenson, MD 310-556-0185

• Phase I Trial of VELCADE and Thalidomide. Phase I exploratory study of combination VELCADE and Thalidomide in refractory multiple myeloma. Investigator: Bart Barlogie, MD, PhD 501-526-CARE (2873)
  
  
• Phase I/II Trial of VELCADE + Adriamycin + Dexamethasone. (UK only) Phase I/II study to assess the safety, efficacy, and tolerability of combination therapy with VELCADE, Adriamycin, and dexamethasone (PAD) as primary therapy for patients with multiple myeloma. Investigator: Jamie Cavanaugh, MD +440 207 601 8202
  

• Myeloma Matrix?(updated 08/07/03)
  The Myeloma Matrix provides updated information about drugs beginning with pre-clinical developments and tracks drugs as they proceed through Phases I ? III of clinical trials, drugs that have been FDA approved, and information on trials that are being conducted by NCI- sponsored cooperative groups as well as other myeloma study groups. The online version is updated regularly. If you would like to have a printed copy, call the toll-free hotline (800) 452-2873.
  
  
• Cancer Trials Support Unit: A Web Based System That Offers Efficient and Effective Tools for Clinical Trials Management.
  The Cancer Trials Support Unit (CTSU) is an NCI funded program to facilitate participation (by both patients and physicians) in phase III NCI sponsored Cancer treatment trials.

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.

• Advocates Needed to Contact Congress to Increase Medical Research Funding
  Leaders in the Senate and House are moving to increase funding for the National Institutes of Health (NIH) above the 2.5% recommended by President Bush need your voices of support within the next two weeks. Learn how you can make your voice heard in support of two very important initiatives.
  
  
• Cancer Patients and Public Policy: The Importance of Advocacy
  Hosted by the Raleigh-Durham, North Carolina Myeloma Support Group, this special meeting will feature IMF Advocate Greg Brozeit. October 15, 2003.
  

• Torino Patient & Family Seminar
  Turin, Italy
  September 12, 2003

• Paris Patient & Family Seminar
  September 19, 2003

• Heidelberg Patient & Family Seminar
  Heidelberg, Germany
  September 26-28, 2003

• Philadelphia Patient & Family Interactive Seminar
  October 17-18 2003

• Tokyo Patient & Family Seminar
  Tokyo, Japan
  November 2, 2003

• Dallas Patient & Family Interactive Seminar
  Baylor University Medical Center
  November 7-8, 2003

• IVth International Conference on Cancer-Induced Bone Diseases
  San Antonio, Texas
  December 7-9, 2003
  Put on by the Paget Foundation, conference will cover the spectrum of bone metastases caused by breast cancer, prostate cancer, and osteolyic lesions due to myeloma. IMF Board Member Gregory R. Mundy, MD is Conference Chair.

FUNdraising Made Easy
You know you want to do something, but deciding on what to do can be confusing. The IMF can help. This year, our members really rallied 'round the cause, picked up the gauntlet, and raised a lot of money for myeloma research and programs. We are already getting calls from new members who want to join in the effort and hold an event in 2004. Suzanne Battaglia is waiting for your call. She is here to help you plan and execute your event, so please write, call or email (SBattaglia@myeloma.org) so that you can get on our Calendar of Events! See what you can do in your community to help further the goal of finding the cure!

Ralph Ferrizzi Memorial Golf Tournament August 23, 2003 Allentown, PA

• Ribbon of Hope Making A World of Difference Anniversary Gala
  October 4, 2003
  Paul Allen's Experience Music Project Museum in Seattle, WA
  
  The evening promises to be the best ever, both creatively and financially! The EMP is Seattle's most unique architectural wonder. The Frank O. Gehry-designed building houses a new interactive museum that combines performance space, technology and revolutionary architecture in a facility created to celebrate the heritage and anticipate the future of American popular music.
  
  
• Third Multiple Myeloma Quilt of Courage is Online
  The third quilt is finished and on the web. Like the two before it, it is both beautiful and moving. Take a look for yourself.
  
  Several people who purchased squares for the 4th and final quilt were not able to complete them. Therefore, we have had to send out new squares to people on a waiting list, and we are now waiting for them to return their finished squares. They've been given a deadline of mid to end of August, so we're hoping to have the 4th quilt up on our web site by the first week in September. For all of you who finished and sent back your 4th quilt square in a timely fashion, we apologize for the delay.
  
  
• GTC Telecom is reaching out on behalf of the IMF with a wonderful new way for you to help fight myeloma while saving yourself money at the same time!
  By signing up for the new IMF Long Distance Plan, 10% of what you spend on your long distance calls every month will be directly donated to the International Myeloma Foundation. This fantastic long distance plan offers you savings of up to 40% or more over what you may currently be paying! Click on the link to find out more.

• BANK ON A CURE^?
  BANK ON A CURE^? is an innovative and powerful concept designed to establish a method to find new treatments for multiple myeloma and other related diseases as well as the possibility of new cures, while customizing care for current patients.
  

• International Prognostic Index
  The International Myeloma Foundation is proud to sponsor the International Prognostic Index (IPI) Classification for Multiple Myeloma. Nearly twenty myeloma institutions from around the world are collaborating to create an updated staging system for multiple myeloma.

• NexCura Cancer Profiler
  The Cancer Profiler is a free service (no hidden fees or charges). Its tools provide you with information specific to your cancer diagnosis to help you make more informed treatment decisions along with your physician.

• Expert Opinions on Multiple Myeloma
  A multimedia, CME-accredited program for physicians with the chance to see world-renowned myeloma specialists sharing their knowledge, discussing treatment choices, and comparing their perspectives on controversial issues in multiple myeloma and related diseases.

• MMInteractive
  An exciting new way for myeloma patients to get involved at patient seminars.

• Myeloma At The Movies
  It has been our goal to bring our Patient & Family Seminars to people around the country who might not be able to attend an actual meeting, so we have set up a video lending library. New tapes have recently been added from the Seattle Patient & Family Seminar.

• The Catlett Card Series
  The Catlett Cards are designed by Irma Catlett in memory of her husband Lou. The stunning pictures on these cards chronicle their travels together and honor Lou and the life they shared. Blank on the inside, they are perfect for thank-you's, birthdays, anniversaries, and just general correspondence. All proceeds go to support the programs of the IMF.
  

• IMFers Esther and Herman Adler, of Adler & Company Jewelers in Los Angeles are continuing their generous offer to help the IMF. Buy beautiful jewelry at wholesale prices and?if you tell them you are an IMFer?a portion of the proceeds will be donated to the IMF. They make it so easy, too. They can work from digital pictures if you cannot meet with them, and they have a return policy if you are not completely satisfied. Call them at 213-624-1945 for more information.
  
  

Shop for 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 Cure page. You can also use the special shortcut URLs listed below:

amazon.myeloma.org	barnesandnoble.myeloma.org	buy.com.myeloma.org
delta.myeloma.org	disney.myeloma.org	drugstore.myeloma.org
ftd.myeloma.org	jandr.myeloma.org	landsend.myeloma.org
microwarehouse.myeloma.org	marshallfields.myeloma.org	netritition.myeloma.org
1800flowers.myeloma.org	proflowers.myeloma.org	sharperimage.myeloma.org
staples.myeloma.org	target.myeloma.org	travelocity.myeloma.org
	walmart.myeloma.org

So, Shop For The Cure by using these links to the same get great service and low prices you're used to while helping support the IMF!