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March 1, 2009

Live Report from IMW - Day 3: Chief Medical Officer, Susan Kelley

The proceedings on Day 3 of this 4 day meeting were just as energetic as the prior two days. The general scientific sessions and abstract presentations started at 6:30 in the morning and ran through 6:30 in the evening. It is quite gratifying to see over 1,200 scientific researchers and clinicians discussing data, sharing research results and challenging each other to ensure that the most important questions to be addressed in multiple myeloma receive attention. Among the important scientific sessions today, was a presentation by the Consensus Panels of the International Myeloma Working Group. These three Consensus groups reached out to a total of over 150 experts in multiple myeloma worldwide, through a series of meetings and teleconferences. Three areas of myeloma diagnosis and treatment were addressed and three reports have been generated. The reports are available on the IMW website and will be published in a major medical journal later this year.

Guidelines for the Uniform Reporting of Clinical Trials in Myeloma: this report presents a standard approach for clinical trials to evaluate new treatments in myeloma, including standard definitions of patient populations, types of clinical data to be collected on a trial, and how to present the results of a trial, so that the findings across important trials may be interpreted consistently. View guidelines http://www.mw-delhi09.com/spargoDocs/Consensuspanelone.pdf

· Guidelines for Risk Stratification in Myeloma: The committee members stressed that, currently, to mandate definitive treatment according to cytogenetic abnormalities is premature. Additional randomized prospective studies are needed to validate the relationship of particular risk factors to treatment outcome or to assign patients with specific cytogenetic (chromosomal) abnormalities to specific treatment regimens. Instead, these guidelines provide a suggested set of risk factors that can be evaluated to help assess prognosis. View guidelines http://www.mw-delhi09.com/spargoDocs/Consensuspaneltwo.pdf

· Guidelines for Standard Investigative Work Up in Myeloma (Diagnosis and Staging): The standard procedures (laboratory and clinical tests) that should be conducted at the time of initial diagnosis and at subsequent relapse or disease progression have been agreed and outlined. View guidelines http://www.mw-delhi09.com/spargoDocs/Consensuspanelthree.pdf

In another session there was a presentation of viewpoints from myeloma experts in the US, Italy and France regarding the approaches to timing and type of bone marrow transplant or stem cell transplant in myeloma. Dr. M. Cavo from Italy reminded the audience of the favorable 20-30% Complete Response rates being reported with use of the newer therapies (lenalinomide and/ or bortezimib combination therapy) in the treatment of newly diagnosed myeloma. There are important questions to be answered in upcoming studies, regarding the timing of ASCT (stem cell transplant) in patients who may derive good, durable response after 4-5 cycles of treatment with the newer treatment regimens.

February 28, 2009

Live Report from IMW - Day 2: Program Director, Anne Quinn Young

Day two of the XIIth IMW represented the transition day from a predominant focus on basic science and translational research to clinical data. The first clinical session of the day included representatives from 5 countries discussing recent and planned cooperative group Phase III clinical trials in each of their countries. Cooperative group trials are government organized and run, with industry funding and/or drug support provided in most cases. These trials tend to address questions that require data with long-term follow-up, such as: What is the optimal induction regimen prior to high-dose therapy and stem cell transplant? Is it better to combine three or four drugs upfront or sequence them? What is the value of a stem cell transplant in the age of novel therapies? What is the role of maintenance therapy? And so on.

Past cooperative group trials have addressed questions like the value of a second (consecutive) transplant; superiority of MP plus novel agents vs MP alone for newly diagnosed, transplant ineligible patients; optimal dosing of dexamethasone in combination with Revlimid (lenalidomide) for first-line therapy; and the role of Thalomid (thalidomide) as maintenance therapy.

What was striking about the planned trials from the various groups was their complementary nature. Many of the questions mentioned above have been addressed in countries such as France, Spain, Italy, the Netherlands, and the UK, where participation in clinical trials is often upwards of 50% of patients. With so many possible combinations and sequences, and so many critical late stage trials underway in the U.S. to address these questions, it is important for patients to participate in clinical trials. Otherwise, progress in the field will be slowed. To find a trial that is right for you or your loved one, call 866-603-MMCT (6628) or visit www.myelomatrials.org.

There were also many presentations of data related to novel investigational treatments in early stage (Phase I and II) clinical trials. Nine of these were from MMRC-supported trials! These new trials can be loosely broken into three groups: trials involving treatments that are already FDA-approved for other indications, eg, Zolinza (vorinostat) and Torisel (temsirolimus) and could be prescribed off-label for MM; investigational treatments (not FDA approved for any use) that represent second generation proteasome inhibitors such carfilzomib and NPI-0052 or pomalidomide, a new IMiD; and novel treatments that hit new targets such as perifosine or elotuzumab. But, with so many exciting new treatments, without increased clinical trial participation, we won’t know which are truly promising. Therefore, at any time in your disease – from first-line therapy to multiple relapses – it is critically important to consider a clinical trial.

Stay tuned for more clinical trials data in tomorrow’s report from IMW as well as new data from medical meetings in the spring including ASCO.

February 27, 2009

Live Report from IMW - Day 1: Chief Scientific Officer, Louise Perkins

The biennial International Myeloma Workshop opened today in Washington, DC. This meeting is the 12th such workshop and was originally scheduled to be held in New Delhi. The unfortunate events in Mumbai of late 2008, prompted the organizers to move the meeting to a different city and in just 7 weeks they were able to identify Washington as the new venue. Kudos to Drs. V. Rajkumar, S. Jagannath, N. Munshi and V. Raina for their successful efforts to do so.

This first day of the meeting started with review and discussion of research leading towards an improved understanding of what treatments should be matched to which patient and when. There is a great deal that has already been done to establish risk parameters in the context of the high-dose chemotherapy and transplant. However, as newer drugs come into wider use and are used in different combinations, it is necessary to create fresh perspectives on “risk” that are relevant to those treatments. Why is this important? Here is just one example. Increasing evidence indicates that patients whose myeloma is t(4;14) – historically viewed as denoting “high-risk” - can be effectively treated with the addition of Velcade to treatment regimens. It is important to mention that these studies are not definitive, but the data are encouraging and it seems likely that many other like situations will be found.

Among the highlights for the day were a comprehensive review of the genomic changes seen in patient samples and the possible targets for therapeutic intervention that can be gleaned from those studies. In addition, the MMRC Genomics Initiative findings and data portal were highlighted in three separate presentations by Drs. Kuehl, Bergsagel and Stewart. It was great to see these important data being used and discussed to benefit patients.

Clearly, a great deal of research has and continues to be done to identify new targets and develop new drugs that patients will be able to rely upon should they fail the existing therapeutic approaches.

February 26, 2009

MMRF Founder, CEO Kathy Giusti: Live Report from IMW

Thirteen years ago, when I was first diagnosed with multiple myeloma, I was told I would live three years and would not see my daughter, then only one, start kindergarten. I attended my first International Myeloma Workshop (IMW) that same year in Boston. I was struck by the commitment and passion of the myeloma research community, but also made very aware that there were few effective treatments, minimal research investment into the disease, and an empty product pipeline.

Back then, I never would have imagined how far we have come.

  • Four lifesaving treatments approved by the FDA in four years that have helped almost double the life expectancy for some myeloma patients
  • Some of the most talented, committed people focused on myeloma, including more than 1,000 doctors, scientists and others at today’s IMW meeting
  • A research landscape that has dramatically shifted from a focus on viruses, immune therapy, and transplants, to developing novel compounds and combination approaches to effectively treat myeloma patients at all stages of the disease
  • A phenomenal pipeline of compounds that may represent the next generation of treatments

Looking back, I also never thought I would be here today, sharing incredible moments that I never dreamt I would see. It is sometimes hard to believe, but my daughter, Nicole, is now a high-school cheerleader, and my son, David, who was a month old when I spoke at my first IMW meeting, is an all-star athlete who led his team to the Little League World Series this past summer.

I am so proud that the MMRF has been part of the amazing progress that has been made in the field of myeloma and so grateful for the extraordinary support and generosity of our donors who have been there every step of the way.

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